Welcome to the TMI Blog - In this blog you will find the musings of Dr.Mayer about diabetic related material on and off of the internet. Be sure to follow us on Twitter or join our newsletter to get the latest info from this blog.
Robert Frykberg,DPM, MPH PRESENT RI Editor Diabetic Limb Salvage
Descriptive Statistics
As we discussed last month , I thought that we might start out with our Primer on Biostatistics from a clinician’s standpoint. I know that statistics can be daunting for those of you who are like I was – having a dislike of mathematics and not having a clue about statistics. The amazing thing is that you can learn so much about a study simply by reading the tables, the numbers, graphs, and figures. Many readers might just go to the tables and figures if the abstract has gotten their interest. I can still remember one of my professors in graduate school telling us that he only read the abstracts of papers to digest their meaning and rarely did he actually read the entire paper. I am somewhere in between – if the abstract is not interesting, I don’t really care to read the paper. If it is and has some good data to report, I will read the paper and specifically look at the tables and graphs to get a real insight into the methodologies as well as the important results.
All of this, however, presupposes that the reader has a basic understanding of medical statistics and knows what he/she is reading. I can’t say that I really did for all of my training and the first 14 years of practice – a real shortcoming! You need to be an educated consumer of the medical literature in this century if you are to stay abreast of developments. So let’s make it as easy as possible and start with the basics first. Digest the information in this series in small quantities so that it is comprehensible and meaningful. Again, I am a clinician, so things need to be made clear to me in a simplified manner that I can understand. I’ll try to do the same for you.
To Start — Descriptive Statistics
Descriptive statistics will be our starting point because of their basic nature and fundamental importance to a discussion of statistics. Although we haven’t yet discussed Student t-tests, you have obviously heard of this basic analytical method for hypothesis testing. But you very likely do not realize that it is most often used inappropriately. This is because the users (or authors) did not pay attention to the descriptive attributes of their study data. In this regard, t-tests require that the data follows a normal distribution (bell curve or parametric) and not a skewed distribution (non-parametric). See Figure 1 below. Specific to our point at this time, however, a t-test is used to test differences between means of two populations or matched pairs. Aside from frequencies (percentages or crude numbers), measures of central tendencies lie at the heart of descriptive statistics. The three measures of central tendency that describe populations are mean, median, and mode. Most of us are familiar with means– the mathematical average of a sum of values (divided by the count or number of values summed). This is a very simple concept that we have all mastered in grade school. However, the mathematical average value of a population/distribution does not always give an accurate picture of that population.
Figure 1. Normal distribution or “Bell” curve (top). Skewed distribution (bottom)
Remember that the mean follows the tail – this means that a single skewed or aberrant result way out of line (i.e. excessively large or small) will affect the average value by skewing that average toward that outlier value. While describing the mean is appropriate for a normally distributed population (where the mean lies in the center of the curve), it is not appropriate for a non-parametric dataset (population). For data that is not normally distributed but skewed, it is appropriate to measure the center of the data by its median. The median is defined as the middle value when the numbers are arranged in increasing or decreasing order. For instance, if we have the following five values of 2, 3, 5, 9, and 10, the median or middle value would be 5. This is fine for an odd number of individual values (half are larger and half are smaller), but for an even number of values (datapoints) the median is defined as the average of the two middle values. For instance, in the following data set of six values ( 2, 6, 10, 13, 17, and 20), the average of the two middle values (10 and 13) is 11.5 – thus, it is the median value of this dataset. It best describes the center of this dataset.
The final measure of central tendency is the mode. The mode is described as the most common value occurring in a set of numbers. If we have a set of five prices from five sources for a new statistical calculator, the iCalc, that includes: $150, $155, $150, $160, and $159.50, we can easily see that the mode is $150. This is the value (price) that occurs most frequently from these sources.
The Three Measures of Central Tendency:
Mean – the mathematical average of a sum of values
Median - the middle value when the numbers are arranged in order
Mode - the most common value occurring in a set of numbers
Interestingly, for a perfectly symmetric distribution (Bell curve, normal distribution), the mean, median, and mode will all fall at the center of the curve. For skewed populations, the mean will always follow the tail (outliers) such that it lies on one or the other side of the curve, adjacent at some level to the median value. The mode will usually be found toward the high point of the curve, reflecting the most commonly occurring value. (Figure 2)
Figure 2. In the normal curve (top), the mean , median, and mode are all at the same point. In the negatively skewed curve below, the three measures of central tendency are at different points (values) along the curve.
That’s it for now- we will keep things simple so you can assimilate these concepts. They will be your building blocks for the future. If I can understand statistics, so can you! I have provided references for you below and suggest that you do some reading on your own.
My hope is that you too will be amazed at the Power of Numbers...
See you next time.
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
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REFERENCES:
Statistics. Cliffs Notes, Lincoln Nebraska. David Voelker and Peter Orton. 1993
"More people must get the care they deserve to drastically reduce the number of preventable amputations.”
The Putting Feet First campaign will highlight how good practice results in reduced amputation rates.
'Unacceptably high' number of diabetes amputations in Wirral
A NATIONAL campaign group has criticised the “unacceptably high” number of amputations in Wirral involving people with diabetes.
Diabetes UK has launched its Putting Feet First campaign this week aimed at lowering the number of “preventable” amputations.
It reveals that Wirral Primary Care Trust has 1.17 major amputations per 1,000 adults with diabetes, compared to the national average of .99 per 1,000 and that from 2008 to 2011, Wirral had 66 major amputations per 1,000 adults living with diabetes.
It disclosed further that during the same period 136 adults living with diabetes across Wirral had amputations and there were 850 episodes of care for diabetic foot disease accounting for 8,906 nights in hospital.
Over the three-year period 366 patients were admitted across Wirral PCT for foot disease.
Helen Pattie, Diabetes UK NW regional manager, said: “A single preventable amputation is one too many and the number of amputations in Wirral PCT is unacceptably high.
We need to see an improvement in the way care is organised.
"More people must get the care they deserve to drastically reduce the number of preventable amputations.”
The Putting Feet First campaign will highlight how good practice results in reduced amputation rates.
It aims to reduce diabetes related amputations by 50% over the next five years and to raise awareness of people living with diabetes in understanding how important it is to look after their feet and having them checked regularly.
CHICAGO | New research gives clear proof that weight-loss surgery can reverse and possibly cure diabetes, and doctors say the operation should be offered sooner to more people with the disease—not just as a last resort.
The two studies, released on Monday, are the first to compare stomach-reducing operations to medicines alone for “diabesity” —Type 2 diabetes brought on by obesity. Millions of Americans have this and can’t make enough insulin or use what they do make to process sugar from food.
Both studies found that surgery helped far more patients achieve normal blood-sugar levels than medicines alone did.
The most proper name for the surgery would be diabetes surgery
The results were dramatic: Some people were able to stop taking insulin as soon as three days after their operations. Cholesterol and other heart risk factors also greatly improved.
Doctors don’t like to say “cure” because they can’t promise a disease will never come back. But in one study, most surgery patients were able to stop all diabetes drugs and have their disease stay in remission for at least two years. None of those treated with medicines alone could do that.
“It is a major advance,” said Dr. John Buse of the University of North Carolina at Chapel Hill, a leading diabetes expert who had no role in the studies. Buse said he often recommends surgery to patients who are obese and can’t control their blood-sugar through medications, but many are leery of it. “This evidence will help convince them that this really is an important therapy to at least consider,” he said.
There were signs that the surgery itself —not just weight loss—helps reverse diabetes. Food makes the gut produce hormones to spur insulin, so trimming away part of it surgically may affect those hormones, doctors believe.
Weight-loss surgery “has proven to be a very appropriate and excellent treatment for diabetes,” said one study co-leader, Dr. Francesco Rubino, chief of diabetes surgery at New York-Presbyterian Hospital/Weill Cornell Medical Center. “The most proper name for the surgery would be diabetes surgery.”
The studies were published online by the New England Journal of Medicine, and the larger one was presented Monday at an American College of Cardiology conference in Chicago.
More than a third of American adults are obese, and more than 8 per cent have diabetes, a major cause of heart disease, strokes and kidney failure. Between 5 million and 10 million are like the people in these studies, with both problems.
For a century, doctors have been treating diabetes with pills and insulin, and encouraging weight loss and exercise with limited success. Few very obese people can drop enough pounds without surgery, and many of the medicines used to treat diabetes can cause weight gain, making things worse.
Surgery offers hope for a long-term fix. It costs $15,000 to $25,000, and Medicare covers it for very obese people with diabetes. Gastric bypass is the most common type: Through “keyhole” surgery, doctors reduce the stomach to a small pouch and reconnect it to the small intestine.
One previous study tested stomach banding, a less drastic and reversible procedure for limiting the size of the stomach. This technique lowered blood sugar, but those patients had mild diabetes. The new studies tested permanent weight-loss surgery in people with longtime, severe diabetesAt the Cleveland Clinic, Dr. Philip Schauer studied 150 people given one of two types of surgery plus standard medicines or a third group given medicines alone. Their A1c levels _ the key blood-sugar measure _ were over 9 on average at the start. A healthy A1c is 6 or below.
One year after treatment began, only 12 per cent of those treated with medicines alone were at that healthy level, versus 42 per cent and 37 per cent of the two groups given surgery.
Use of medicines for high cholesterol and other heart risks dropped among those in the surgery groups but rose in the group on medicines alone.
“Every single one of the bypass patients who got to 6 or less got there without the need for any diabetes medicines. Almost half of them were on insulin at the start. That’s pretty amazing,” said a study co-leader, Dr. Steven Nissen, the Cleveland Clinic’s cardiovascular chief.
An obesity surgery equipment company sponsored the study, and some of the researchers are paid consultants; the federal government also contributed grant support.
The second study was led by Dr. Geltrude Mingrone at the Catholic University in Rome, with Rubino from New York. It involved 60 patients given one of two types of surgery or medicines alone. The researchers set as their goal an A1c under 6.5—the level at which someone is considered to have diabetes.
Two years later, 95 per cent and 75 per cent of the two surgery groups achieved and maintained the target blood-sugar levels without any diabetes drugs. None of those in the medicine-alone group did.
There were no deaths from surgery and only a few complications. Four patients in the Cleveland study needed second surgeries, and two in the Italian study needed hernia operations. Doctors note that uncontrolled diabetes has complications, too _ many patients wind up on dialysis when their kidneys fail, and some need transplants.
An adult who has a body mass index (a calculation based on height and weight) of 30 or more is considered obese. That’s 203 pounds or more for a 5-foot-9 man, for example.
The government recently lowered the criteria for use of gastric bands from a BMI of 35 down to 30 in diabetics or people with heart disease, opening the way for wider use of this and other procedures for obesity.
Dr. Alvin Powers, director of the Vanderbilt University diabetes centre, said the results are very encouraging for people like those in these studies _ very obese, with diabetes that can’t be controlled through less drastic means.
“We still don’t know the long-term outcomes of these surgeries” and whether the benefits will last for more than a few years, he said.
Others were more positive.
The studies “are likely to have a major effect on future diabetes treatment,” two diabetes experts from Australia, Dr. Paul Zimmet and George Alberti, wrote in an editorial in the medical journal. Surgery “should not be seen as a last resort” and should be considered earlier in treating obese people with diabetes, they wroteJon Diat is a success story. Diat, 50, who works at Citigroup and lives in New York, had been piling on pounds and pills for cholesterol and high blood pressure. After he needed an artery-opening procedure he was diagnosed with diabetes, but medicines for that failed to keep his disease under control and worsened his obesity.
“I was maxed out on the medications. It was very grim,” he said. Two years ago, he had weight-loss surgery from Rubino.
“They told me, ‘You’re going to see rapid results,’ but it was amazing. I literally lost 70 pounds in the first three months,” he said. “I was off insulin within less than 72 hours of surgery. I am in complete, total remission of diabetes. My blood sugars are normal.”
Now he eats right, plays tennis and hockey, walks the two miles home from work and takes 12 flights of stairs to his apartment.
“I look at this as a second chance at life,” he said. “It’s been liberating.”
Tamikka McCray, 39, who also lives in New York and works for the city’s Human Resources Administration, also had success from her surgery a year and a half ago. When she left the hospital, her diabetes had disappeared before any major weight loss had a chance to occur.
“That was the crazy part,” she said. “I didn’t understand that when they came in and they checked it. My sugars were normal.” She added: “I left the hospital with no medication. And I haven’t been on anything since.”
Mark Wahba Emergency Room Physician, Saskatoon Health Region mywahba@mac.com
Remember when you were a kid and you or a sibling collected sports cards? They came in wax paper packs with hard sticks of chewing gum (always broken). Whether they were hockey, baseball or football they were all similar: a photo of a player on the front with a write-up on the back. The photo was great: a cool action shot or perhaps the stock head and shoulders portrait.
But the best parts were the biographical snippets on the back. Everyone knew what the player looked like. But what were they really like?
Where were they born? Where did they start their career? What’s their nick-name?
There were team cards. Cards with trophies on them. Special edition cards.
These cards gave you a glimpse into the players’ lives. Made them human. Check out the Mets’ Gregg Jefferies card here. Who knew he loved baseball so much? Other cards gave you some background into a team's history. Some told the origins of a particular award and who had won it.
They also connected you to a world that you watched from the outside - made you a part of the team. What does it mean to be an "Oiler", a "49er" or a member of the "Red Sox?" What does it take to win the Most Valuable Player award or the Most Sportsmanlike Player? How many times have the Canadiens won the Stanley Cup? (Twenty-four, but who’s counting.)
I wonder if patients feel the same way. Being an outsider in a hospital and watching the world around them from the inside. Wondering what the people are really like.
How about this? Healthcare trading cards.
Think of it. At each new patient encounter, the staff member would hand the patient one of their cards. All the doctors, nurses, support staff, everyone. The card would have the staff member’s first name and photo on the front with a little write-up on the back. Maybe something like:
Richard. Team: Housekeeping. Started with health region in 1987. Wizard with the floor waxer. Takes pride in making the patient's stay as comfortable as possible. Easy to work with and always a smile on his face.
Francis. Team: Nursing. Started with health region in 1996. Experience with surgical and obstetrical nursing. Has a special gift of comforting patients and families before and after surgery. Favorite part of nursing is getting to know her patients. Favorite technical skill is dressing changes.
Team card. 5B: Surgery. 20 bed surgical unit: 16 regular and 4 high-level observation. 1 charge nurse with 5 nurses each shift. Our motto "Excellent pre- and post-operative care. No pain shall be left unmanaged."
Printing tens of thousands of cards to give to each patient coming through the doors would be expensive and not very environmentally friendly. So how about a virtual card for everyone? Each ID badge could have a QR code it. (That's one of those black and white boxes that you take a picture of with your phone which then takes you to a website. [1])
Patients could scan the code and find out who their team is. Maybe even have a spot on the website to leave some feedback for the employees. It would be a great way to close the feedback loop so sorely missing in healthcare. Combine this idea with a fully functioning patient-centred electronic health record and Wow! You’d completely connect the whole team.
What a great way to get patients involved and humanize the care experience. Instead of a crowd of anonymous white coats in the room during bedside rounds there would be:
Rachel, 4th year medical student: studied education before medicine, wants to work with children.
Fernando, junior resident: likes operating. Wants to develop a better technique to reduce post op infections.
Heather, senior resident: Going to Ottawa for a vascular fellowship. Hopes her children will adapt well to the new school.
Ivan, attending general surgeon: specializes in laparoscopic surgery. Volunteered his surgical skills in Haiti last year.
These cards could become part of the patient’s personal health record. Based on their experiences, patients would have favourites, their own personal dream teams. The aide who played cribbage with you during his break might be your equivalent of a Wayne Gretzky or Reggie Jackson rookie card.
The most valuable card of all would be the patient's, which reveals the person behind the case, the life that transcends the disease. No longer would it be "the woman with colon CA in bed 12" or “the guy in bed 2 with dementia waiting placement.” Instead it would be "Adele, mother of 3. Accountant. Likes to be called by her first name. Fears that the colostomy bag will leak when she's at work." And “Maj. Richardson. Served in World War 2 spending time in the Netherlands. Owned a hardware store and is a skilled woodworker.”
Healthcare cards would give both staff and patients a glimpse into the person behind the face, the white coat, or the gown. In an often impersonal, high-tech, fast-paced medical world, maybe there’s something to learn from the sports trading cards that helped kids who wanted to know, “What are those people really like?”
Though not a baseball fan, Dr. Mark Wahba found inspiration in the bestselling book Moneyball, leading him to think of new ways in which medicine can use statistics to achieve better results.
Two years ago, emergency physician Dr. Mark Wahba was searching for an innovative way to improve efficiency at the Royal University Hospital in Saskatoon as part of a provincial health-care quality control program he was taking.
He finally found what he was looking for in a pub 500 kilometres away in his hometown of Estevan, on Saskatchewan’s border with North Dakota.
“I was having a beer with an old friend and he said, ‘You’ve got to read this book,’ ” recalls Dr. Wahba, a clinical assistant professor of medicine at the University of Saskatchewan.
The book was American sportswriter Michael Lewis’s 2003 book, Moneyball: The Art of Winning an Unfair Game, the bestselling story of how Billy Beane, general manager of the Oakland Athletics, used statistical analysis to build winning teams made up of low-budget players whose baseball talents were overlooked by big-market Major League Baseball competitors such as the New York Yankees and Los Angeles Dodgers.
“When I read it, I was amazed, absolutely floored,” says Dr. Wahba. “The similarities between the Oakland Athletics and our health-care system were striking: We were both trying to provide big-league services with restricted budgets.”
That epiphany prompted Dr. Wahba to approach Mary Smillie, a former consultant with the Health Quality Council of Saskatchewan, and Steven Lewis, a baseball fan and health policy professor at Simon Fraser University in Burnaby, B.C., to talk about if and how Canada’s public health-care system could benefit from Beane’s game-changing approach to baseball.
The result of their discussions is a new blog called “M.A.S.H.”—Meaningful Analogies in Sports and Health.
Launched on the Open Medicine website in October (to roughly coincide with the late-September release of the book-based hit movie Moneyball, starring Brad Pitt), the blog is devoted to exploring how medicine and health care can profit from the development, use and application of statistical analysis in sports.
The similarities between the Oakland Athletics and our health-care system were striking: We were both trying to provide big-league services with restricted budgets.
“Our operative theory is that health care would get better if it used data as adeptly as baseball—and, increasingly, other sports—to improve decision-making and quality,” the trio wrote in their first entry on the website (http://blog.openmedicine.ca/mash).
“We suspect that many others out there agree in principle.”
Though the site is open to sports-medicine analogies of all kinds, Dr. Wahba says he believes that baseball—a sport for which he says he has little affinity as a fan—was the perfect entry into the discussion because of its widespread and time-honoured use of statistics and analysis.
“Professional baseball by far predates all other sports in regards to data collection,” he says.
He notes, for example, that baseball managers, coaches, players and even fans routinely follow and compare in minute detail almost every aspect of the sport, from pitches thrown and the resulting strikes and balls, to batters’ hitting averages based on multiple factors including left- versus right-handed pitching, pitch counts and having runners in scoring positions.“Numbers are in the very DNA of baseball,” says Dr. Wahba. “It is a series of highly discrete events, every one of which can be shown to affect the outcome of a game.”
He adds that other sports—notably professional hockey, football and basketball—are also now collecting and using analytical data in an effort to both gain competitive advantage and to select players who have the best chance of success in their sport.
“There is no doubt that the use of statistics is now widespread in sport, and that they are enhancing performance,” says Dr. Wahba.
Contrast that with health care, “which has an enormous inventory of unexplored data, underused analysis and, in too many places, a culture that regards data with suspicion and even hostility.”
In their initial paper on the blog, the MASH founders write that in the world of professional sports, “the difference between success and failure sometimes hinges on minor differences in capacity and execution.
“Health and health care are, of course, far more fundamental to the human condition. Often, people live because of evidence-informed practice or die because the evidence has been ignored.”
To date, the site has a handful of entries that explain what analogies might be drawn between sports and health data.
Dr. Wahba, for example, considers which data could explain outcomes. “The batting average explains less about a player’s performance than previously assumed; being overweight (but not obese) has less adverse impact on health status than previously assumed,” he writes. But there are “perils of focusing too narrowly on a performance metric. . . . Fielding average does not tell us much about fielding performance; 30-day postsurgical mortality or readmission rates may be less meaningful than one-year quality-of-life outcomes.”
He advances a similar possibility for the importance of case-mix adjustment.
“A pitcher who yields three runs a game in a hitter-friendly ball park may be better than a pitcher who yields 2.5 runs a game in a park with distance fences; a surgeon with a higher crude mortality rate may be more skilled than one with a lower rate who takes easier cases.
“Understanding luck or random outcomes (good or bad),” he adds, “a pitcher who strikes out few batters but gives up few runs may be living on borrowed time; a hospital with no hand-washing protocol but (with) no major infection outbreaks may be likewise rolling the dice.”
A recent MASH blog, which Lewis posted on Dec. 6, is entitled “Do clinicians need spring training?”
“Baseball,” it reads, “has spring training and no one is exempt from the drills, the repetitions (and) the fine tuning. It is not just a rite of spring; it is fundamental to the pursuit of excellence.
“Baseball assumes that skills are impermanent, mastery is fleeting, coaching is essential, and practice never ends. Health care assumes that skills, once achieved, are permanent, mastery comes with time, coaching is unnecessary and practice is for students. Baseball has it right.”
He notes that to succeed like Billy Beane, hospital and health-care stakeholders—everyone from administrators to medical staff—need to completely rethink their time-honoured approaches to chronic problems.
For Dr. Wahba, the goal of the MASH blog is to stimulate debate, participation and enjoyment among readers and writers alike
“The first question we should be asking ourselves is, ‘What exactly are we trying to accomplish?’ ” says Dr. Wahba. “From there it’s a matter of working backward to figure out how to make it happen.”
He says he hopes the MASH blog will get people thinking along those lines.
“A measure of success,” says Dr. Wahba, “would be if it inspires a single person to do something that improves a patient’s experience or outcome.”
HOLLYWOOD (CBS) — Leaders in the medical world met in Hollywood Thursday for a global conference on diabetes care.
The Diabetic Foot Global Conference (DFCon) focuses on amputation prevention and foot and wound care.
The conference, now in its tenth year, was started by Dr. George Andros, the Medical Director of the Amputation Prevention Center at Valley Presbyterian Hospital, and Dr. David Armstrong, Professor of Surgery at the University of Arizona.
The conference is the largest of its kind in the world.
The founding doctors said that there is a misconception among people with diabetes.
“If you take all the patients that come in and have this sore on their foot and the ulcer that puts them at risk for amputation, I ask them, ‘what do you think your chances of saving your foot are?’ And they say, ‘Aw, not very good doc – 5 percent?’ Well I say, ‘You got the right number, but the wrong way around.’ We save 95 percent of the feet that come to us at risk of amputation,” Dr. Andros said.
“So the patients come in quite despondent and depressed and I think after we’ve seen them and talked with them — but most importantly after we’ve treated them – I think they feel a lot less depressed and a lot happier about their lives,” he added.
“The great news is that there’s hope and that is what we’re seeing in meetings like this. We have folks now from 50 nations, all 50 states, from 15 different medical, surgical, nursing disciplines that are here at DFCon that are now going to go back to their country as delegates, as champions and try to make a difference,” said Dr. Armstrong.
There are only four specialized clinics, like the ones at Valley Presbyterian and the University of Arizona, in the country.
The doctors said that more are needed and that is why the conference is so important.
For more information, visit DFCon online at http://dfcon.com/
Posted by: PV Mayer at 02:54 pm 2 comments - Add a Comment Category: Diabetic Foot Ulcer Treatment
(Reuters Health) - People with diabetes may have better blood sugar control during workouts if they lift weights before doing cardio exercise, according to a new study by Canadian researchers.
It's important to define the best way for people with type 1 diabetes to exercise so that blood sugar doesn't drop too low, yet they can still reap all the benefits of aerobic exercise, Dr. Ronald Sigal, an endocrinologist at the University of Calgary in Canada and lead author of the study told Reuters Health.
Those with type 1 diabetes, a condition in which the body does not produce its own insulin, a hormone needed to convert food into fuel, risk low blood sugar during exercise. Blood sugar that drops too low can lead to poor coordination, unconsciousness or even coma.
About five percent of all Americans with diabetes, or roughly 1.3 million people, have type 1, which is often diagnosed in childhood, according to the Centers for Disease Control and Prevention.
Twelve fit people with type 1 diabetes, who already ran and lifted weights at least three times per week, participated in the new study. The 10 men and two women averaged 32 years old.
They met researchers at the laboratory for two experimental exercise sessions, which were held at least five days apart.
At one session, participants did 45 minutes of treadmill running followed by 45 minutes of weight lifting. They switched the order for the other session.
Each workout started at five o'clock in the evening to simulate a common time of day people might exercise after work, said Sigal.
Researchers measured blood sugar levels before, during and after exercise for each participant.
In people with type 1 diabetes, target blood sugar levels can range from about 4 to 10 millimoles per liter of blood (mmol/L).
Researchers interrupted participants before blood sugar became too low for safety reasons -- if it fell below 4.5 mmol/L, participants stopped and ate a snack.
When participants did aerobic exercise first, blood sugar dropped closer to that threshold and remained lower for the duration of the workout than when they lifted weights first and ran second.
Lifting weights first was also associated with less severe drops in blood sugar hours after exercise, and post-exercise drops that did occur tended to last a shorter period of time.
The current study, published in the journal Diabetes Care, echoes previous research showing that aerobic exercise causes a more rapid decrease in blood sugar than weightlifting.
“Your muscles utilize sugar very quickly in aerobic exercise," Dr. Vivian Fonseca, chief of endocrinology at Tulane University Medical School told Reuters Health. He was not involved in the current work.
The study was small, and the researchers acknowledge that other factors, which they did not measure, could be at work, rather than the exercise order. For example, they did not account for levels of a number of hormones that could also lead to changes in blood glucose during exercise.
Nor did they have control over participants' food and activity choices prior to exercise --the authors wanted the study to reflect real-life conditions faced by people with type 1 diabetes.
Because study participants were young, active people with type 1 diabetes, it's not clear whether the findings would apply to less fit people with type 1 diabetes or people with type 2 diabetes.
“While the study findings are very intriguing, they may have limited practical value until more studies are done," said Fonseca.
Still, the authors conclude, those people with type 1 diabetes who tend to develop low blood sugar during exercise “should consider performing their resistance exercise first."
SOURCE: bit.ly/yItDRO Diabetes Care, online February 28, 2012.
We here at TMI like the idea of reducing carbs sensibly to trim the fat. This study gives our patients another innovative angle to help them tackle one the most difficult aspects of diabetes management.
Low Carbs for Just Two Days a Week Spurs Weight Loss
Adhering to a strict, low-carbohydrate diet two days per week led to greater reductions in weight and insulin levels when compared with standard daily dieting.
Can you diet for just two days a week? You might be able to drop more weight if you cut back on carbs just two days a week.
The study's lead author Michelle Harvie, a research dietician at the Genesis Prevention Center at the University Hospital in South Manchester, England stated that, "We came up with the idea of an intermittent low-carb diet because it enables people to still have foods that are very satiating." "Also, there's a lot of evidence from other studies showing that restricting carbohydrates has the same effect as restricting energy."
British researchers found that women who essentially gave up carbs for two days and ate normally the rest of the time dropped about 9 pounds on average, as compared to the 5 pounds lost by women who cut back to around 1,500 calories every day, according to a new report presented at the CTRC-AACR San Antonio Breast Cancer Symposium.
Harvie and her colleagues were spurred to find a diet that would be easier for women to follow because research has shown that obesity and the changes it causes in the body increase the risk for breast cancer. "We know from our research in animal models that losing weight has the potential for reducing breast cancer risk," Harvie said.
The researchers followed 88 women for four months. All the women were at high risk for breast cancer based on their family histories. One third of the women were put on a Mediterranean-type diet that restricted calories to about 1,500 per day. A second group was told to eat normally most of the time, but two days a week to cut carbs and also calories to about 650 on those two days. The third group was also to cut carbs two days a week, but there was no calorie restriction on those days.
At the end of four weeks women in both of the intermittent dieting groups had lost more weight -- about 9 pounds -- than the women who ate low calorie meals every day of the week -- about 5 pounds.
Women in the intermittent dieting groups also had better improvement than daily dieters in the levels of hormones -- insulin and leptin -- that have been linked with breast cancer risk, Harvie said. And, yes, this is something you can try at home, Harvie said. You just need to dramatically cut back carbohydrates two days a week and try to eat sensibly the rest of the time, she added.
What that means, Harvie said, is that you can eat protein and healthy fats on the two low carb days, but skip bread, pasta, root vegetables like potatoes, carrots and parsnips to get to the 50g limit. The diet allows for one piece of fruit on the low carb days. Other foods on the menu include: nuts and green, leafy vegetables, peppers, mushrooms, tomatoes, broccoli, eggplant and cauliflower.
Presented at the CTRC-AACR San Antonio Breast Cancer Symposium Nov. 2011
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
The Challenges of Diabetic Foot Infections (Part 3): A Brief Primer on Antibiotics
In the last couple of issues of Footnotes, we have been discussing the assessment and non-pharmacologic management of diabetic foot infections. Certainly, infection is that complication that so often leads to tissue loss – and in the presence of ischemia, directly contributes to limb loss. Antimicrobial therapy is the third element of care for diabetic foot infections (DFI) – third because antibiotics should be considered adjunctive to surgical management, although this 3rd rail is crucial to effective eradication of bacterial pathogens in this difficult setting.
I am a clinician, not an infectious disease specialist. But having been in the trenches with such patients for a good many years, I’ve learned a little about antimicrobial management for DFIs. Granted, I’ve made many mistakes to go along with the successes. Hopefully, those experiences have made me somewhat wiser in my approach to such patients. Relatively mild or non-limb threatening infections are generally straightforward to manage with oral agents. For the purposes of this Foot Notes, however, we will concentrate on the more serious DFIs requiring hospitalization (IDSA Grade 3-4).
Simplification, while appreciating the magnitude of the problem at hand, is always best. Many years ago, the standard “cocktail” for hospitalized patients with DFI consisted of triple therapy with Gentamicin, Ampicillin, and Clindamycin (or cephalothin). This regimen would cover most Gram negative rods (GNR), Gram positive cocci (GPC), as well as anaerobes. MRSA was not the problem that it is today. As you have surmised, we must have done a lot of harm to the diabetic kidneys with the aminoglycosides. In the mid-seventies, we didn’t have carbapenems or extended spectrum penicillins (with or without beta-lactamase inhibiting agent combinations). With the advent of Imipenem, Ticarcillin, amoxicillin-clavulanate, and then piperacillin, and piperacillin/tazobactam, our options expanded dramatically. Soon, we were able to treat even the most severe of infections with a single empirical agent in many cases. Of course, then as now, penicillin (PCN) allergic patients presented a little more difficulty. Clindamycin even today remains a mainstay of treatment for such patients, although the options are quite a bit more numerous than before. Hence, we can discuss antimicrobial management in terms of severity of infection, as well as in the setting of PCN-allergic patients. This is obviously a simplistic approach, but in most cases, this approach will be sufficient for the average clinician to provide for reasonable initial empirical therapy. As always, antibiotic regimens need to be fine tuned and adjusted, based on culture and sensitivity (C&S) results, patient response, and renal function.
Only three currently marketed antibiotics have a specific indication for diabetic foot infections: piperacillin/tazobactam, linezolid, and ertapenem. These are great agents, and found to be superior to their various comparators in clinical trials (see references). Nonetheless, these agents are not always effective for all patients or pathogens (or combinations of pathogens). Hence, we usually provide parenteral empirical therapy with combinations of agents, until our C&S results have been returned.
Common antibiotics used for the management of diabetic foot infections
Aside from the need to empirically cover GNRs, GPC (especially Staph aureus and Group B Streptococci), and anaerobes, we must now be vigilant for the predominance of MRSA in the United States. Since more than 50% of our staphylococcal isolates in my facility are MRSA, we always empirically cover for this organism. For this, we add Vancomycin to our broad spectrum agent, Piperacillin/Tazobactam. One could just as easily prescribe Vancomycin plus ertapenem to achieve very broad coverage (even in PCN allergic patients). Whereas amoxicillin/clavulanate previously was my combination agent of choice, it no longer has the Gram positive and Gram negative spectrum that it once enjoyed. I do not really like vancomycin, due to rising minimum inhibitory concentrations (MIC) required, as well as its nephrotoxicity in diabetic patients with acute renal failure. Linezolid is a far more effective drug (that can also be given orally), but with a rising number of patients on SSRI agents for depression – especially in the Veteran population- we must be cognizant of Serotonin syndrome. Therefore, we use this agent primarily for documented MRSA infections in patients who have failed or responded poorly to vancomycin. I suppose daptomycin would be an equally good choice in this regard. Again, once our initial cultures have been returned with sensitivities, we narrow our coverage accordingly- to the simplest effective agent. Nafcillin or cefazolin are the single agents most often used for methicillin-sensitive staph aureus (MSSA) or streptococcal infections. For purely streptococcal infections, (excluding enterococcus) we prefer intravenous Penicillin G until we can safely switch to the oral formulation. For Enterococcus faecalis, we prefer ampicillin in some format (or vancomycin if being used for MRSA).
For the PCN allergic patient, we rely very much on Clindamycin, Ciprofloxacin, and vancomycin (or linezolid). While Ciprofloxacin will provide coverage for most GNRs, clindamycin will cover MSSA, streptococci (not enterococcus), and even anaerobes. Occasionally, it will even cover MRSA. Furthermore, it can be safely used in patients with impaired renal function. Vancomycin is a more certain coverage for MRSA (as well as MSSA) and enterococcus. We will generally start those with moderately severe infections on a combination of Vancomycin and oral Ciprofloxacin for fairly broad coverage (but not good anaerobic coverage). Hence, for severe infections and necrotizing infections, it makes sense to add clindamycin to this regimen or at least metronidazole. Linezolid can also be considered for excellent GPC coverage – MSSA, MRSA, streptococcal, and enterococcus (including VRE). Again, tailoring coverage to isolated pathogens once sensitivities are known will make your patients and pharmacists very happy.
I have left many possible agents or combinations out of this discussion for the sake of simplicity. In managing your patients, however, you must always consider the severity of the infection, prior cultures, local antibiogram profiles, renal function, concurrent medications, and general allergy profiles. It is also wise to be familiar with the profiles of your favorite antimicrobial agents – know the pathogen coverage they provide as well as the gaps in coverage. Remember that if the patient dos not respond within 24 to 48 hours, you have missed something. This could be an undrained abscess, ischemia, or a resistant or untreated pathogen. For particularly difficult patients, infections, or pathogens, I will consult my infectious disease specialist for help. Things can go downhill awfully quickly in this patient population. Nothing says it better than this quote from Louis Pasteur in 1880:
“The germ is nothing. It is the terrain in which it is found that is everything”
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References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on eTalk.
Best regards,
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
REFERENCES
Eneroth M, Apelqvist J, Stenstrom A. Clinical characteristics and outcome in 223 diabetic patients with deep foot infections. Foot Ankle Int. Nov 1997;18(11):716-722.
Frykberg RG. An evidence-based approach to diabetic foot infections. Am J Surg. Nov 28 2003;186(5A):44S-54S; discussion 61S-64S.
Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-Oct 2006;45(5 Suppl):S1-66.
Lipsky BA, Berendt AR, Deery HG, et al. Diagnosis and treatment of diabetic foot infections.Clin Infect Dis. Oct 1 2004;39(7):885-910.
Caputo GM, Cavanagh PR, Ulbrecht JS, Gibbons GW, Karchmer AW. Assessment and management of foot disease in patients with diabetes. N Engl J Med. Sep 29 1994;331(13):854-860.
Grayson ML, Balaugh K, Levin E, Karchmer AW. Probing to bone in infected pedal ulcers. A clinical sign of underlying osteomyelitis in diabetic patients. J Am Med Assoc.1995;273(9):721-723.
Lavery LA, Armstrong DG, Wunderlich RP, Mohler MJ, Wendel CS, Lipsky BA. Risk factors for foot infections in individuals with diabetes. Diabetes Care. Jun 2006;29(6):1288-1293.
Eneroth M, Apelqvist J, Stenstrom A. Clinical characteristics and outcome in 223 diabetic patients with deep foot infections. Foot Ankle Int. Nov 1997;18(11):716-722.
Frykberg RG. An evidence-based approach to diabetic foot infections. Am J Surg. Nov 28 2003;186(5A):44S-54S; discussion 61S-64S.
Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-Oct 2006;45(5 Suppl):S1-66.
Javier Aragón-Sánchez, Yurena Quintana-Marrero, Jose L. Lázaro-Martínez, et al: Necrotizing Soft-Tissue Infections in the Feet of Patients With Diabetes: Outcome of Surgical Treatment and Factors Associated With Limb Loss and Mortality. INT J LOW EXTREM WOUNDS 2009; 8; 141
Javier Aragón-Sánchez: Seminar Review: A Review of the Basis of Surgical Treatment of Diabetic Foot Infections International Journal of Lower Extremity Wounds 2011 10: 33
Lipsky BA, Itani K, Norden C. Treating foot infections in diabetic patients: a randomized, multicenter, open-label trial of linezolid versus ampicillin-sulbactam/amoxicillin-clavulanate.Clin Infect Dis. Jan 1 2004;38(1):17-24.
Lipsky BA, Armstrong DG, Citron DM, Tice AD, Morgenstern DE, Abramson MA. Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial. Lancet. Nov 12 2005;366(9498):1695-1703.
Frykberg RG, Wittmayer B, Zgonis T. Surgical management of diabetic foot infections and osteomyelitis. Clin Podiatr Med Surg. Jul 2007;24(3):469-482, viii-ix.
Warren Joseph: Handbook of Lower Extremity Infection. Data Trace Publishing
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
The Challenges of Diabetic Foot Infections: (Part 2)
In the last issue of FootNotes, we focused on what I consider to be the essential components in the assessment of patients presenting with diabetic foot infections. Although I concentrated on severe or limb threatening foot infections, the principles remain the same for even mild or moderate infections: always be suspicious, always look for ischemia, and always obtain appropriate laboratory tests and imaging procedures as essential parts of your evaluation. Also important, please recognize that just having a wound does not imply that it is infected; most, if not all, wounds are contaminated. Infection is a clinical diagnosis based on those classical signs we are all familiar with: rubor, tumor, dolor, and calor. Nonetheless, diabetes (like syphilis) has become the great masquerader in that typical signs and symptoms are masked – especially in the presence of neuropathy. Hence, my exhortation that one must always be suspicious in such patients who often do not respond to treatment the way one would expect them to under normal circumstances (i.e. persistent fever after several days of ostensibly appropriate therapy).
So now let us focus on the management of established diabetic foot infections that have been appropriately evaluated. Our focus will always be aimed at limb salvage, a much harder task in many cases than primary leg amputation!
Management of Diabetic Foot Infections
Antibiotics are only part of the management strategies for these complicated patients, although a significant component, of course. In most cases, however, antimicrobial therapy becomes adjunctive to non-pharmacologic (surgical) therapy. An old adage from my years of training in Boston stipulates that diabetic patients cannot tolerate undrained infection (I believe this comes from an old friend and surgeon, Gary Gibbons). This is a good point to remember, since it is painfully driven home whenever it is forgotten! As I mentioned earlier, those patients not responding to antimicrobial therapy alone likely are failing due to an undrained abscess or retained necrotic tissue. This is a very common scenario and one that is seen especially frequently in those patients with necrotizing soft tissue infections (necrotizing fasciitis, necrotizing cellulitis, clostridial myonecrosis, etc.). These patients typically require several trips to the operating room before their infection is controlled- short of doing a primary major amputation. Last month, I presented a case of necrotizing soft tissue infection. (Figure 1 ) As in this case, such patients do not always present with gas in the soft tissues – that would be too easy. Gas easily identifies those individuals requiring an urgent trip to the operating room – few would miss this clinical clue. Nonetheless, many individuals present with severe cellulitis and some soft tissue necrosis even in the absence of purulent drainage.
Fig. 1. Necrotizing soft tissue infection- no gas on x-rays but note the severe cellulitis, edema, and necrotic dorsal skin. The portal of entry was in the webspace at the base of the second toe. No ischemia was present.
They may or may not be sick (IDSA Grade 4 or 3), but the severity of their infection is signified by recalcitrant hyperglycemia, leukocytosis, and failure to resolve cellulitis with broad spectrum antimicrobial therapy. These important clinical clues should indicate that, very likely, surgical debridement or partial foot amputation is necessary. Several procedures are often required prior to eventual control of infection and definitive closure. (Figures 2-4)
Fig. 2. Same patient after initial extensive debridement and toe amputations. Although infection somewhat improved, further necrosis and persistent cellulitis required further debridement.
Fig. 3. After further debridement and toe amputations, the infection came under control. A large soft tissue and osseous defect remained with residual necrosis at the midfoot, placing the limb at risk.
Fig. 4. Definitive closure was obtained with a Chopart amputation.
Equally important is the necessity for detecting and treating peripheral ischemia (PAD) when present. Many patients with pre-existing PAD have a foot infection as their first presenting sign of ischemia. In the presence of neuropathy, critical limb ischemia is often silent in that the usual symptoms of claudication or rest pain are absent. Therefore, in all patients presenting with acute foot infection it is prudent to look for underlying PAD and request appropriate vascular studies and consultations. That being said, ischemia does not preclude appropriate surgical management for the acute infection. It is still essential to drain abscesses or to perform emergent local amputations to control infection. Revascularization should be performed after immediate control of infection. A final, definitive procedure such as a closed amputation or skin graft should follow the revascularization and restoration of perfusion to the foot.
We have previously discussed the management of osteomyelitis in Diabetic Footnotes Issue 18 - Osteomyelitis — Now What?, but it is worth mentioning again in the overall context of managing diabetic foot infections. I am of the (biased) opinion that in the diabetic foot, osteomyelitis is best managed surgically in most instances. While this is a matter of debate around the Globe, surgical debridement or bone resection (and sometimes local amputation) with adjunctive systemic antimicrobial therapy seems to more predictably affect a cure than treatment with just antibiotics. This is the course of treatment followed by most US surgeons until prospective studies can definitively identify those sites or patients best suited to medical therapy alone. Nonetheless, osteomyelitis very rarely, if ever, presents as an acute problem – it usually comes associated with an acute soft tissue infection.
Once the acute infection has been managed, the bone infection can be definitively treated as appropriate for the circumstances. For instance, in a patient with an infected plantar ulcer of a metatarsal head without gangrene, a joint resection with a 4 to 6 week course of culture-directed oral antibiotics will most often result in a “cure”.
I have not specifically addressed antimicrobial therapy thus far, because I think that we need to place a good deal of emphasis on the surgical management of limb threatening infections. Nonetheless, in our next issue, we will discuss my approach to antimicrobial management of diabetic foot infections – from a clinician’s viewpoint. I have been in the trenches for many years in this regard and have made many mistakes. Hopefully, I’ve learned from them and can offer some guidance to you as well. Until next time…
###
References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on eTalk.
Best regards,
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
REFERENCES
Eneroth M, Apelqvist J, Stenstrom A. Clinical characteristics and outcome in 223 diabetic patients with deep foot infections. Foot Ankle Int. Nov 1997;18(11):716-722.
Frykberg RG. An evidence-based approach to diabetic foot infections. Am J Surg. Nov 28 2003;186(5A):44S-54S; discussion 61S-64S.
Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-Oct 2006;45(5 Suppl):S1-66.
Lipsky BA, Berendt AR, Deery HG, et al. Diagnosis and treatment of diabetic foot infections.Clin Infect Dis. Oct 1 2004;39(7):885-910.
Javier Aragón-Sánchez, Yurena Quintana-Marrero, Jose L. Lázaro-Martínez, et al: Necrotizing Soft-Tissue Infections in the Feet of Patients With Diabetes: Outcome of Surgical Treatment and Factors Associated With Limb Loss and Mortality. INT J LOW EXTREM WOUNDS 2009; 8; 141
Javier Aragón-Sánchez: Seminar Review: A Review of the Basis of Surgical Treatment of Diabetic Foot Infections International Journal of Lower Extremity Wounds 2011 10: 33
It appears that we here at TMI are not alone in our frustration with less than timely vascular referrals for our patients with PAD. We need to do better.
Guideline neglect observed for limb ischemia
U.S. study uncovers substandard care for patients facing amputation
WRITTEN BY ED SUSMAN ON FEBRUARY 27, 2012 FOR CANADIANHEALTHCARENETWORK.CA
MIAMI BEACH, FLA. | Despite recommendations that patients at risk of amputation be referred to vascular surgeons, barely one-third of doctors at one institution complied with those guidelines.
But a review of patients’ charts also found the recommendation was just one of many American Heart Association/American College of Cardiology recommendations for patients with chronic critical limb ischemia that had poor compliance, according to Dr. Laura Harmon, a surgery resident at Scott & White Hospital in Temple, Texas. She conducted the retrospective study at Texas Tech University Health Sciences Center in Odessa.
“Only 36% of our patients in this study got beyond the primary caregiver,” Dr. Harmon said at her poster presentation during the 2012 International Symposium on Endovascular Therapy here. “The problem is not that our facilities are isolated and don’t have specialists available. We are just not getting the referrals to the appropriate people.”
Dr. Harmon and colleagues reviewed cases of lower limb amputation from 2006 to 2010 to determine how well doctors were doing at following the 2005 guidelines.
She found that of the 314 patients in the study: • 26% were referred to institutional smoking cessation programs • 32% had surgical revascularization procedures • 34% underwent assessment of additional ischemic risk factors • 34% had endovascular revascularization procedures • 36% were referred to a vascular specialist • 38% were on statin prescriptions • 39% were given hemodynamic diagnostic studies • 56% were given prescriptions for antiplatelet therapy • 59% had imaging studies to define underlying vascular anatomy.
“Despite the guidelines for lower extremity arterial disease management, a substantial gap exists between current recommendations and clinical practice,” Dr. Harmon said. “Our goal in performing this study was to bring some attention to this situation in our home facility and say: ‘Hey, we are not doing this right.’”
She said plans are in place to determine if greater compliance with guidelines can be achieved through the education of physicians and allied health-care professionals.
If a man loses his leg in Sierra Leone — from the blast of a land mine or in a horrific car accident — chances are he will not be able to get an artificial limb.
Those used in Canada and the U.S. are too expensive, costing many thousands of dollars each. And if a limb were available, it would likely be too primitive for him to use.
But Jan Andrysek, a scientist at Holland Bloorview Kids Rehabilitation Hospital, has developed a cheap and functional artificial limb for those who have had their leg amputated above the knee.
It costs just $50. Comparable limbs have a $3,000 price tag.
On Thursday, Andrysek received a $100,000 grant to further develop his innovative limb, prosaically dubbed the Low-Cost Prosthetic Knee Joint, or the LC Knee. The award is one of 15 handed out by Grand Challenges Canada, an independent non-profit organization funded by the federal government, to Canadian researchers working to improve global health conditions.
Researchers whose ideas prove successful are eligible for an additional $1 million to help get their innovation to the people who need it most.
Andrysek, a rehab engineer, says designing the limb had its challenges. It had to be simple, but robust enough to withstand rough terrain, whether unpaved roads or mountain paths. It had to be comfortable so those who use the limbs could go back to work, often the hard physical labour of farming. It also needed to be inexpensive, yet made of high-quality materials that could last for years without need of repair.
A key component of the limb is its unique knee mechanism that functions much like the human joint.
“It automatically locks and unlocks itself based on how the person is putting their weight on the limb,” Andrysek says, noting that many of the artificial limbs used in developing countries have outdated manual locks on the joints.
“The mechanisms and technologies used are based on designs from post-World War II. They have not changed in 50 years.”
In addition to the novel design, which cut costs, Andrysek made the LC Knee of low-cost thermoplastics which could be mass-produced using injection molding techniques.
“We can now mold all the pieces for a knee for about $15,” he says. “These are fairly complex parts that have a complex structure and integrity and strength.”
An added bonus of using plastic? The knee is waterproof, increasing its chances of working well in humid environments.
Andrysek plans to use the $100,000 grant to further test the LC Knee in developing countries, including Ethiopia, Colombia and Nicaragua.
Toronto Innovators
15 Canadian researchers received $100,000 grants from Grand Challenges Canada. The money is to be used to help get innovative health solutions to people in the poorest regions of the world. Four grants went to Toronto researchers.
Lu Chen from the University of Toronto is developing a low-cost, portable device to monitor HIV progression in patients, a service usually unavailable to those in resource-poor areas.
Helen Dimaras from the University Health Network is working on a way to quickly evaluate the progression of cancer in patients living in rural Africa.
Ophira Ginsburg from Women’s College Research Institute is designing a mobile phone tool for community health workers to use to encourage women in rural Bangladesh to seek help for breast cancer, a disease for which many women do not get treated until it is too late.Toronto Scientist
For patients with HIV, strictly adhering to their regimen of antiretroviral drugs is not just critical but life-sustaining. So when patients admit to drug noncompliance, doctors are faced with how to help them take their drugs as prescribed.
But rather than engaging in open-ended conversations to address barriers to adherence such as side effects, patient misunderstanding and scheduling, physicians tend to ask yes-or-no questions and tell patients what to do, said a study published online Jan. 31 in the journal AIDS and Behavior.
As important as medication compliance is to HIV care, only 10% of discussion time with patients is devoted to antiretroviral treatment, said the study, based on audio recordings of patient visits to physicians and other health professionals. Researchers categorized the discussions based on whether they were expressive, emotional, empathic, directive, problem-solving, joking and so on.
Nearly half the patients prescribed antiretroviral medications told researchers they were less than 100% drug-compliant. About 90% of the time, these patients did hear from their physicians about the importance of drug adherence, but doctors focused on problem-solving just 23% of the time. When discussing medication compliance, the physicians and other health professionals studied typically asked four closed or leading questions and rarely asked open-ended questions or checked if patients understood what they were being told.
"Even when there is problem-solving talk, there is very little of it," said Ira B. Wilson, MD, senior author of the study. "What's going on instead of problem-solving is what we call directives. It's natural in the course of the physician-patient dialogue around medication adherence for physicians to encourage, to exhort, to cheerlead patients. ... If you're going to help people problem-solve, you need to have a discussion about those problems."
Patients with HIV are likelier than other patients to have struggles with employment, housing and substance abuse, the study said.
Not just an HIV care problem
Generally, between 30% and 60% of all patients fail to take their medicines as prescribed, according to previous research cited in the study. The rate at which physicians take a patient-centered approach to improving drug compliance is probably lower among physicians treating patients with illnesses other than HIV, said Dr. Wilson, chair of the Dept. of Health Services, Policy & Practice at the Warren Alpert Medical School of Brown University in Providence, R.I.
"Everybody knows the game in HIV care is very much about medication adherence. If patients take their meds, they can turn this fatal disease into a chronic illness. Look at Magic Johnson," Dr. Wilson said. "Awareness of, consciousness of, discussion of medication adherence in most other conditions is probably much less. I think this is as good as it gets."
Physicians ought to receive more training on how to employ motivational interviewing and other techniques that can help spur higher adherence rates, Dr. Wilson said. Simply asking patients how they feel about their medications can solicit a lot of information about their drug-taking habits.
"This research is not a criticism of physicians," he added. "This is an observation about the culture that's grown up around complicated behaviors such as medication nonadherence, and our difficulties in cracking that nut and solving that problem. ... We need to get over the idea that we just give the patient information and then it's up to them to take action."
One of the main problems with diabetic peripheral neuropathy is that, when someone is affected with it, he or she is unaware when pressure-induced damage is being done.The result is tissue damage, leading to ulceration, and often, amputation.
The patented SurroGait Rx is a high-tech, pressure-sensing insole that tells the user when damage is being done to the feet and provides substitute sensation for “numb” feet. The SurroGait Rx includes a high-resolution pressure-sensing insole and a low-profile, ergonomic back display. Pressure information collected in the shoe is wirelessly sent in real-time to the back display.The back display transposes sensation that would otherwise be felt on the foot onto the back, so that the user can “feel” his or her feet through the back. With practice, through the incredible phenomenon of neuroplasticity, the user will “rewire” his or her brain so that interpreting the feeling on the back is second nature.
This device is intended to not only prevent and treat the complications of peripheral neuropathy, but also to enable improved gait and balance, and decrease the risk of falls inherent to the problem of not being able to properly feel the feet.
Clinical trials will begin with the SurroGait Rx in early 2013.
Our Solution
The SurroGait System uses a sensor grid to measure pressure over the bottom of the foot. Using a wireless communication profile this data is then transmitted to a back-display. A low-power processor is then used to analyze the data and convert it into a signal that can be used to stimulate the lower back. Using this stimulus the patient is able to feel the pressure exerted on the feet in a 1-to-1 fashion. A lightweight battery and state-of-the-art electronics in the back display allow the system to be ergonomic and low-profile to reduce visual impact of the device. A wristband display or mobile device can be used to control the intensity of the stimulus, as well as monitor battery life and pressure information.
Toronto's medical community is buzzing about an invention that could change the way health professionals screen for infectious disease and cancer.
"We've been working on this, really, for about a decade," said Dr. Shana Kelley, a scientist at the University of Toronto.
Kelley spoke as she held a small black device her hand, shaped like a smartphone but bulkier, with a microchip inside that Kelley says can determine in 15 minutes if you have cancer or an infectious disease.
The device works with a blood sample or swab placed on a microchip. It then reads — and recognizes — certain types of cells.
Kelley says eventually there will be a disposable cartridge that contains the sample.
Instead of days, or sometimes weeks, before patients get their results, with the new machine they're ready in minutes.
For those on health care's front-lines, the promise of an early diagnosis means more lives can be saved.
"Infectious disease is the medical condition where rapid turnaround is maybe most critical and our chip, coupled with portable instrumentation, are good at providing very fast answers," Kelley said.
It could also save the health care system millions. In the case of detecting prostate cancer it means no more lengthy, costly and uncomfortable biopsies.
"I think it's superb and very exciting," said Dr. Robert Nam, an uro-oncologist at Sunnybrook Hospital, who believes Kelley and her team's invention will transform the medical community in Canada and abroad.
"We can identify patients with most lethal cancer…and, secondly, how about avoiding a biopsy?" he said.
Canada and the United States have invested millions and there's a European company that's jumped on board with more cash for this invention, which they hope will be in use in a couple of years.
Expectations are high.
"It will allow physicians out in the field, and I'm thinking public health physicians, to be able to assess patients right then and there," said Dr. Frances Jamieson, a medical microbiologist with Public Health Ontario. She highlighted tuberculosis as one possible disease the new device could diagnose faster.
Dr Perry Mayer Dr. Perry Mayer treats patients with diabetic foot and wound issues in his Railway Street clinic. Many of his patients are on such a long wait list for surgery that they run the risk of loosing a limb. Mayer sends these patients to Toronto for surgery even though the surgery could be done here in Hamilton.
Cathie Coward/The Hamilton Spectator
Diabetes patients in danger of losing limbs are being sent to Toronto for treatment because Hamilton’s waits are too long.
The Mayer Institute, which specializes in diabetes wound care, sends patients needing urgent treatment, within 30 days, to vascular surgeons at Sunnybrook Health Sciences Centre instead of waiting for diagnostics and surgery at Hamilton Health Sciences or St. Joseph’s Healthcare.
“In my world, I wait an inordinate amount of time,” said the institute’s medical director, Dr. Perry Mayer. “It’s a ridiculous situation in Hamilton. We have brilliant, gifted surgeons here, they’re second to none. But their hands are tied.”
Hamilton’s lead vascular surgeon says the problem is that 90 per cent of patients referred to them are urgent, so it can be difficult to determine who gets the care first.
“A lot of us feel overwhelmed with the sheer volume of disease,” said Dr. David Szalay, division head of vascular surgery at HHS, St. Joseph’s and McMaster University. “The challenge can be to try to work through your list and make sure nobody dies of a ruptured aneurysm waiting for you, nobody has a stroke waiting and you can intervene on the leg quick enough to prevent limb loss.”
Szalay says the delays occur when patients are referred and waiting for their first appointment and again when surgeons order diagnostic tests. In contrast, Toronto has more vascular surgeons to share the load, so patients get their first appointment faster. The doctors at Sunnybrook also have access to their own angioplasty suite so they do the diagnostics themselves and immediately do the treatment.
“Their model is ideal but pretty unique,” Szalay said of Sunnybrook.
Angelo Maletta says he would have lost his foot if he’d waited any longer for treatment. The 61-year-old Welland maintenance worker was told in August his right foot would have to be amputated because of a diabetic wound.
His cousin knew someone whose leg was saved by Mayer and recommended the clinic on Railway Street. Many of Mayer’s patients tell the same story of finding the institute by chance from friends or family after being told they’d need an amputation.
“My cousin, who I hadn’t seen in months, happened to be at my house the day they told me they wanted to amputate,” said Maletta, who shudders to think what would have happened otherwise. “It would have been terrible for me.”
Maletta saw Mayer at the end of August. Tests showed there was not enough blood flow in his foot, so he was referred to Sunnybrook in October and had surgery on Nov. 9.
“Everything was just boom, boom, boom,” said Maletta, commenting on the speed of treatment.
His foot is now healing well.
Getting treatment fast is significant considering Wound Care Canada reports there is a “small window of opportunity” for therapies. More than 50 per cent of lower extremity amputations are due to non-healing foot ulcers and the long-term prognosis isn’t good for amputees. The death rate is 39 per cent to 68 per cent over a five-year period.
There is hope that waits will ease a bit in Hamilton as another vascular surgeon is being recruited — the equivalent of three fewer surgeons are practising in this area compared to seven years ago. A second vascular ultrasound opened last week to double diagnostic capacity, and other health professionals such as physician assistants are being added to the vascular team.
But until then, Mayer says he will continue to send patients to Toronto: “These people can’t wait. The patients who don’t get to me lose their limbs. They lose their limbs at an astonishing rate.”
The Challenges of Diabetic Foot Infections: Part 1
I’ve had a particularly difficult (and frustrating) week caring for several patients with very severe diabetic foot infections. I’ve been at this for about 35 years now, but it doesn’t seem to be getting any easier. Perhaps the patients are just getting more complex and sicker or perhaps the pathogens are getting more virulent. Regardless, the infections just seem to be getting more difficult to control. While we have many more antimicrobial agents than we did years ago, antibiotics are only part of the solution to managing foot infections in the diabetic patient. We certainly need to have a very good understanding of the spectrum of coverage (and gaps in coverage) for a number of different agents. But the reality is, antibiotics alone can most often NOT be relied on to be the “magic bullet” for managing such complications. In fact, a good friend of mine who specializes in such matters is known to advocate that “draino” is the best (and perhaps the most important) agent for treating diabetic foot infections (DFI). Others can do a better job than I of discussing the multitude of antimicrobial therapies available for treating such infections (and perhaps it might be the subject of a future discussion).
Hence, I will focus here on the non-pharmacologic principles of assessment and management that are critical to success in this regard. For the purposes of our discussion, we will concentrate primarily on limb threatening (moderate or severe) infections.
The Physical Exam
A systematic and thorough evaluation is absolutely essential to detect associated abnormalities that either directly lead to the infection or contribute to its severity. Medical history and evaluation is obviously important for antecedent injuries, comorbidities such as kidney disease, peripheral arterial disease, heart disease, diabetes control and medications, allergies, etc.
A diabetic foot ulcer (DFU) is rarely caused by an infection but is perhaps the most frequent causal factor leading to diabetic foot infections. Sometimes it is just a blister or a burn (especially in the Summer heat of Arizona) or a puncture wound that breaks the skin envelope and opens the portal to infection. In the most severe presentations (necrotizing soft tissue infections) signs will include secondary blisters, bullae, or necrosis proximal to open wounds or gangrenous toes.
Fig. 1. Necrotizing soft tissue infection- no gas on x-rays but note the severe cellulitis, edema, and necrotic dorsal skin. The portal of entry was in the webspace at the base of the second toe.
Palpation of the foot might not only express purulence, but subcutaneous crepitance might be palpable as well. Ulcers of long duration or with bone exposure are at high risk for developing infections. Therefore, it is important to carefully examine such lesions - or to look for them when they might be between the toes. A sterile probe or even applicator stick can be used to examine the depths of any wounds to ascertain bone involvement or exposure or whether sinus tracts extend proximally along fascial planes or tendon sheaths. While this “probe-to-bone” test has been maligned as a good indicator for osteomyelitis, in hospitalized patients with severe infections, it actually has quite good predictive value for osteomyelitis. It is therefore a routine and essential part of my examination.
While many, if not most, of hospitalized patients with DFIs have at least some degree of peripheral neuropathy and sensory loss, you must always look for underlying ischemia. I am quite impressed with the frequency of undetected peripheral arterial disease (PAD) that we first diagnose upon presentation with a rather severe DFI. Perhaps the frequency of neuroischemic wounds has risen over the years; certainly the number of foot infections in such patients has in my clinical practice. Hence, palpation of pulses (at least from the Popliteal to pedal arteries) is a key part of the examination as well. Too often, however, the foot is so swollen that pulses- even when present- are difficult to palpate. This is why I carry a Doppler ultrasound unit in my pocket. I will routinely ascertain the presence and quality of Doppler signals in the pedal vessels. While rarely finding triphasic signals in the affected feet, we will often find biphasic or monophasic signals in the dorsalis pedis and posterior tibial arteries. Monophasic signals portend peripheral arterial disease, although when intermetatarsal artery signals are present, there is less concern for critical ischemia. Nonetheless, we very liberally order Doppler Segmental Limb Pressures and ankle-brachial indices (ABI) or toe pressures for qualitative and quantitative evidence of peripheral perfusion. Pulse volume recordings (PVR) are also quite useful in this regard, especially in the presence of calcified arteries in this patient population. Vascular surgical consultation to assess the need for angiography and revascularization is necessary when significant abnormalities are found.
Imaging
X-rays, of course, must be taken to determine whether there are underlying foreign bodies, deformities (Charcot), or signs of osteomyelitis. Equally important, one must always look for the presence of subcutaneous gas. Necrotizing soft tissue infections, whether caused by anaerobes, gram negative bacilli, staphylococci, or Beta-hemolytic streptococci frequently demonstrate gas accumulations around and proximal to the original focus of infections. Accordingly, plain films of the leg must also be taken to ensure that the foot infection does not involve these fascial planes or tendon sheaths. There are obvious treatment implications –emergent treatment implications- when gas is found in the soft tissues. But air is not gas in this sense of the word- sometimes air is found in the periwound area from walking on the foot. This is called emphysema and this is really not an emergency. When undrained abscesses or osteomyelitis are suspected, MRI or other advanced imaging can assist in making the diagnosis.
Fig. 2. Note the soft tissue defect adjacent to the first MTP joint and the gas at the lateral ankle in this other patient.
Laboratory Studies
Laboratory studies are, of course, critical in determining the patients’ response to the infection and help determine its severity. While complete blood count (CBC), differential, serum glucose, glycohemoglobin, and sedimentation rate are routine labs in this scenario, one must recognize that leukocytosis does not always accompany a moderate or severe infection in the diabetic patient. Hence, the clinician cannot be lulled into a false sense of comfort upon not finding an elevated white blood count (or elevated temperature for that matter). Suspicion and caution are the best attributes of the provider caring for such patients. Routine assessment of renal function is also necessary, following serum creatinine, blood urea nitrogen, and estimated glomerular filtration rate (eGFR). These values will obviously affect antimicrobial dosing as well as consideration for angiography and contrast for MRI studies.
Classification
Once the patient assessment has been completed, classification of the infection will be helpful in guiding treatment. The Infectious Disease Society of America (IDSA) has put forth a DFI Classification scheme that has been almost universally adopted here and abroad. (See Table below) This scheme is an expansion of the former non-limb threatening/ limb threatening classification used several decades ago.
The reader is referred to the references below for an in-depth review of the points discussed in this month’s ezine. Next month, in Part II, we will discuss treatment of the infected diabetic foot. As always, your comments are always appreciated and encouraged.
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References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on eTalk.
Best regards,
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
REFERENCES
Eneroth M, Apelqvist J, Stenstrom A. Clinical characteristics and outcome in 223 diabetic patients with deep foot infections. Foot Ankle Int. Nov 1997;18(11):716-722.
Frykberg RG. An evidence-based approach to diabetic foot infections. Am J Surg. Nov 28 2003;186(5A):44S-54S; discussion 61S-64S.
Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-Oct 2006;45(5 Suppl):S1-66.
Lipsky BA, Berendt AR, Deery HG, et al. Diagnosis and treatment of diabetic foot infections.Clin Infect Dis. Oct 1 2004;39(7):885-910.
Caputo GM, Cavanagh PR, Ulbrecht JS, Gibbons GW, Karchmer AW. Assessment and management of foot disease in patients with diabetes. N Engl J Med. Sep 29 1994;331(13):854-860.
Grayson ML, Balaugh K, Levin E, Karchmer AW. Probing to bone in infected pedal ulcers. A clinical sign of underlying osteomyelitis in diabetic patients. J Am Med Assoc.1995;273(9):721-723.
Lavery LA, Armstrong DG, Wunderlich RP, Mohler MJ, Wendel CS, Lipsky BA. Risk factors for foot infections in individuals with diabetes. Diabetes Care. Jun 2006;29(6):1288-1293.
The Challenges of Diabetic Foot Infections: (Part 2)
In the last issue of FootNotes, we focused on what I consider to be the essential components in the assessment of patients presenting with diabetic foot infections. Although I concentrated on severe or limb threatening foot infections, the principles remain the same for even mild or moderate infections: always be suspicious, always look for ischemia, and always obtain appropriate laboratory tests and imaging procedures as essential parts of your evaluation. Also important, please recognize that just having a wound does not imply that it is infected; most, if not all, wounds are contaminated. Infection is a clinical diagnosis based on those classical signs we are all familiar with: rubor, tumor, dolor, and calor. Nonetheless, diabetes (like syphilis) has become the great masquerader in that typical signs and symptoms are masked – especially in the presence of neuropathy. Hence, my exhortation that one must always be suspicious in such patients who often do not respond to treatment the way one would expect them to under normal circumstances (i.e. persistent fever after several days of ostensibly appropriate therapy).
So now let us focus on the management of established diabetic foot infections that have been appropriately evaluated. Our focus will always be aimed at limb salvage, a much harder task in many cases than primary leg amputation!
Management of Diabetic Foot Infections
Antibiotics are only part of the management strategies for these complicated patients, although a significant component, of course. In most cases, however, antimicrobial therapy becomes adjunctive to non-pharmacologic (surgical) therapy. An old adage from my years of training in Boston stipulates that diabetic patients cannot tolerate undrained infection (I believe this comes from an old friend and surgeon, Gary Gibbons). This is a good point to remember, since it is painfully driven home whenever it is forgotten! As I mentioned earlier, those patients not responding to antimicrobial therapy alone likely are failing due to an undrained abscess or retained necrotic tissue. This is a very common scenario and one that is seen especially frequently in those patients with necrotizing soft tissue infections (necrotizing fasciitis, necrotizing cellulitis, clostridial myonecrosis, etc.). These patients typically require several trips to the operating room before their infection is controlled- short of doing a primary major amputation. Last month, I presented a case of necrotizing soft tissue infection. (Figure 1 ) As in this case, such patients do not always present with gas in the soft tissues – that would be too easy. Gas easily identifies those individuals requiring an urgent trip to the operating room – few would miss this clinical clue. Nonetheless, many individuals present with severe cellulitis and some soft tissue necrosis even in the absence of purulent drainage
Fig. 1. Necrotizing soft tissue infection- no gas on x-rays but note the severe cellulitis, edema, and necrotic dorsal skin. The portal of entry was in the webspace at the base of the second toe. No ischemia was present.
They may or may not be sick (IDSA Grade 4 or 3), but the severity of their infection is signified by recalcitrant hyperglycemia, leukocytosis, and failure to resolve cellulitis with broad spectrum antimicrobial therapy. These important clinical clues should indicate that, very likely, surgical debridement or partial foot amputation is necessary. Several procedures are often required prior to eventual control of infection and definitive closure. (Figures 2-4)
Fig. 2. Same patient after initial extensive debridement and toe amputations. Although infection somewhat improved, further necrosis and persistent cellulitis required further debridement.
Fig. 3. After further debridement and toe amputations, the infection came under control. A large soft tissue and osseous defect remained with residual necrosis at the midfoot, placing the limb at risk.
Fig. 4. Definitive closure was obtained with a Chopart amputation.
Equally important is the necessity for detecting and treating peripheral ischemia (PAD) when present. Many patients with pre-existing PAD have a foot infection as their first presenting sign of ischemia. In the presence of neuropathy, critical limb ischemia is often silent in that the usual symptoms of claudication or rest pain are absent. Therefore, in all patients presenting with acute foot infection it is prudent to look for underlying PAD and request appropriate vascular studies and consultations. That being said, ischemia does not preclude appropriate surgical management for the acute infection. It is still essential to drain abscesses or to perform emergent local amputations to control infection. Revascularization should be performed after immediate control of infection. A final, definitive procedure such as a closed amputation or skin graft should follow the revascularization and restoration of perfusion to the foot.
We have previously discussed the management of osteomyelitis in Diabetic Footnotes Issue 18 - Osteomyelitis — Now What?, but it is worth mentioning again in the overall context of managing diabetic foot infections. I am of the (biased) opinion that in the diabetic foot, osteomyelitis is best managed surgically in most instances. While this is a matter of debate around the Globe, surgical debridement or bone resection (and sometimes local amputation) with adjunctive systemic antimicrobial therapy seems to more predictably affect a cure than treatment with just antibiotics. This is the course of treatment followed by most US surgeons until prospective studies can definitively identify those sites or patients best suited to medical therapy alone. Nonetheless, osteomyelitis very rarely, if ever, presents as an acute problem – it usually comes associated with an acute soft tissue infection.
Once the acute infection has been managed, the bone infection can be definitively treated as appropriate for the circumstances. For instance, in a patient with an infected plantar ulcer of a metatarsal head without gangrene, a joint resection with a 4 to 6 week course of culture-directed oral antibiotics will most often result in a “cure”.
I have not specifically addressed antimicrobial therapy thus far, because I think that we need to place a good deal of emphasis on the surgical management of limb threatening infections. Nonetheless, in our next issue, we will discuss my approach to antimicrobial management of diabetic foot infections – from a clinician’s viewpoint. I have been in the trenches for many years in this regard and have made many mistakes. Hopefully, I’ve learned from them and can offer some guidance to you as well. Until next time…
###
References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on eTalk.
Best regards,
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
REFERENCES
Eneroth M, Apelqvist J, Stenstrom A. Clinical characteristics and outcome in 223 diabetic patients with deep foot infections. Foot Ankle Int. Nov 1997;18(11):716-722.
Frykberg RG. An evidence-based approach to diabetic foot infections. Am J Surg.Nov 28 2003;186(5A):44S-54S; discussion 61S-64S.
Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-Oct 2006;45(5 Suppl):S1-66.
Lipsky BA, Berendt AR, Deery HG, et al. Diagnosis and treatment of diabetic foot infections. Clin Infect Dis. Oct 1 2004;39(7):885-910.
Javier Aragón-Sánchez, Yurena Quintana-Marrero, Jose L. Lázaro-Martínez, et al: Necrotizing Soft-Tissue Infections in the Feet of Patients With Diabetes: Outcome of Surgical Treatment and Factors Associated With Limb Loss and Mortality. INT J LOW EXTREM WOUNDS 2009; 8; 141
Javier Aragón-Sánchez: Seminar Review: A Review of the Basis of Surgical Treatment of Diabetic Foot Infections International Journal of Lower Extremity Wounds 2011 10: 33
The United States of Diabetes: New report shows half the country could have diabetes or prediabetes at a cost of $3.35 trillion by 2020.
More than 50 percent of Americans could have diabetes or prediabetes by 2020 at a cost of $3.35 trillion over the next decade if current trends continue, according to new analysis by UnitedHealth Group's Center for Health Reform & Modernization, but there are also practical solutions for slowing the trend. See this week's Tool for Your Practice.
New estimates show diabetes and prediabetes will account for an estimated 10 percent of total health care spending by the end of the decade at an annual cost of almost $500 billion -- up from an estimated $194 billion this year.
The report, The United States of Diabetes: Challenges and Opportunities in the Decade Ahead,produced for November's National Diabetes Awareness month, offers practical solutions that could improve health and life expectancy, while also saving up to $250 billion over the next 10 years, if programs to prevent and control diabetes are adopted broadly and scaled nationally. This figure includes $144 billion in potential savings to the federal government in Medicare, Medicaid and other public programs.
Key solution steps include lifestyle interventions to combat obesity and prevent prediabetes from becoming diabetes and medication control programs and lifestyle intervention strategies to help improve diabetes control.
"Our new research shows there is a diabetes time bomb ticking in America, but fortunately there are practical steps that can be taken now to defuse it," said Simon Stevens, executive vice president, UnitedHealth Group, and chairman of the UnitedHealth Center for Health Reform & Modernization. "What is now needed is concerted, national, multi-stakeholder action. Making a major impact on the prediabetes and diabetes epidemic will require health plans to engage consumers in new ways, while working to scale nationally some of the most promising preventive care models. Done right, the human and economic benefits for the nation could be substantial."
The annual health care costs in 2009 for a person with diagnosed diabetes averaged approximately $11,700 compared to an average of $4,400 for the remainder of the population, according to new data drawn from 10 million UnitedHealthcare members. The average cost climbs to $20,700 for a person with complications related to diabetes. The report also provides estimates on the prevalence and costs of diabetes based on health insurance status and payer, and evaluates the impact on worker productivity and costs to employers.
Diabetes currently affects about 27 million Americans and is one of the fastest-growing diseases in the nation. Another 67 million Americans are estimated to have prediabetes. There are often no symptoms, and many people do not even know they have the disease. In fact, more than 60 million Americans do not know that they have prediabetes. Experts predict that one out of three children born in the year 2000 will develop diabetes in their lifetimes, putting them at grave risk for heart and kidney disease, nerve damage, blindness and limb amputation.
Estimates in the report were calculated using the same model as the widely-cited 2007 study on the national cost burden of diabetes commissioned by the American Diabetes Association (ADA).
The report also focuses on obesity and its relationship to diabetes. Being overweight or obese is one of the primary risk factors for diabetes, and with more than two-thirds of American adults and 17 percent of children overweight or obese, the risk is clearly rising. In fact, over half of adults in the U.S. who are overweight or obese have either prediabetes or diabetes, and studies have shown that gaining just 11-16 pounds doubles the risk of type 2 diabetes and gaining 17-24 pounds nearly triples the risk.
"Because diabetes follows a progressive course, often starting with obesity and then moving to prediabetes, there are multiple opportunities to intervene early and prevent this devastating disease before it's too late," said Deneen Vojta, M.D., senior vice president of the UnitedHealth Center for Health Reform & Modernization, who helped develop UnitedHealth Group's Diabetes Prevention and Control Alliance.
Diabetes is a major non-communicable disease worldwide. There are now some 40 million people with diabetes – and a similar number with impaired fasting glucose or impaired glucose tolerance – in mainland China alone (China News, 2008). Among those with diabetes, diabetic foot disease is becoming a serious health burden, impacting negatively both on peoples’ quality of life and on healthcare budgets.
The First and Second Diabetic Foot Groups of the Chinese Diabetes Society were founded in 1996 and 2002, respectively. The groups aimed to establish a campaign to improve diabetic foot care in China. This included the participation of the Second Diabetic Foot Group in the International Consensus on the Diabetic Foot, which was published by the International Diabetes Federation (International Working Group on the Diabetic Foot, 2003).
The Third Diabetic Foot Group of the Chinese Diabetes Society was founded in October 2008 and is currently active. This group aims to recruit new members from fields not specifically diabetes related, such as orthopaedic and vascular surgery, but whose contribution to diabetic foot care is essential.
Over the past 5 years, various national meetings on diabetic foot disease and its management and prevention have been held at both local and national levels in China. A number of international experts in the field of diabetic foot care have been invited to China for lectures and clinical visits.
The International Forum on Diabetic Foot and Related Diseases was held in Beijing in 2005 and 2006, in Kunming in 2007, and in Chengdu in 2008. Some 400-500 delegates attended each of these 3-day meetings. Workshops where held, during which approximately 100 participants were divided into groups to learn how to conduct basic examinations of the diabetic foot and investigations for peripheral vascular disease.
A range of topics were covered, including taking an ankle-brachial pressure index and ulcer dressing choice. The workshops were mostly attended by physicians and nurses from teaching hospitals. Many attendees asked the Diabetic Foot Group to hold similar workshops in the future. To date, more than 1500 healthcare professionals have participated in diabetic foot care training provided by the group.
In August of this year, the 5th International Forum on Diabetic Foot and Related Diseases was held simultaneously with the 6th Asia-Pacific Diabetic Limb Problems Meeting in Beijing. More than 500 participants from 16 countries took part. Speakers included Professors Robert Frykberg, Andrew Boulton, David Amstrong, Bejamin Lipsky and Dennis Yue, as well as Marg McGill, Senior Vice-President of the International Diabetes Federation.
There are now more diabetic foot clinics in China than ever before, with seven new centres established in the past 5 years. However, relative to the size of the population with diabetes, there remains too few diabetic foot centres. The clinic at which I work has treated more than 350 people with diabetic foot problems over 5 years. We have been able to achieve a reduction in the amputation rate from 11.5% 5 years ago to 7.2% (mostly minor amputations) today.
Some newer techniques for the management of diabetic foot disease have been used in Chinese clinics. These include vascular intervention (stents, Figure 1), and the transplantation of autologous peripheral blood stem-cells for the treatment of peripheral vascular disease. Autologous platelet-rich gels and negative pressure therapy have also been used for the treatment of hard-to-heal ulcers, with some diabetic foot centres achieving positive results. Some Chinese physicians treat foot problems with a combination of Western medicine and traditional Chinese medicine.
Figure 1. Ischaemic ulcer (a) upon admission to hospital and (b) shortly after. Reperfusion was undertaken, the vascular supply is shown (c) before and (d) after intervention. The ulcer (e) 2 weeks after the intervention, and (f) 2 months after the intervention.
In an effort to increase the amount of literature available to healthcare professionals with an interest in the diabetic foot working in China, the Diabetic Foot Group has undertaken a number of initiatives. The International Consensus on the Diabetic Foot (International Working Group on the Diabetic Foot, 2003) has been translated into Chinese and is now in its second print run, with 6000 copies distributed to-date. The group has worked with experts from a range of fields to produce books that introduced topics on the care of the diabetic foot. The output of literature from China has likewise increased. The number of scientific articles published by practitioners working in diabetic foot care in China has risen dramatically, from 6 in 1996 to 360 in 2006.
In 2004, the Diabetic Foot Group organised research involving 14 teaching hospitals located in cities around China. A range of topics were investigated, including the classification and pathogenesis of diabetic foot disease and peripheral arterial disease, and the cost of diabetic foot disease to hospitals. People (n=634) with diabetes and foot problems or peripheral arterial disease admitted from 1 January to 31 December 2004 were included in this research.
Neuropathy was present in 68.0% of participants, hypertension in 57.4%, peripheral arterial disease in 28.7%, coronary heart disease in 28.5%, cerebral vascular disease in 24.3%, and 38.8% were smokers. Foot ulcers were, in the majority (82.2%) of cases, at Wagner stage 1 or 2. In 42.7% of cases, more than one ulcer was present, and 67.9% of ulcers were complicated by infection. Ulcers were commonly neuroischemic. The average direct medical cost to the hospital attributable to diabetic foot disease or peripheral arterial disease in people with diabetes was ¥RMB 14906/person ($US 1850/person). Our results were presented at the 5th International Symposium on the Diabetic Foot held in The Netherlands (Xu, 2007).
Diabetic foot disease is becoming a serious health and economic burden in China and around the world. The First, Second and Third Diabetic Foot Groups of the Chinese Diabetes Society have looked to provide healthcare professionals working in China with more information on, and clinical skills in, the management of diabetic foot disease. Practitioners in China look forward to increasing national and international cooperation between those with an interest in the care of the diabetic foot, through knowledge-sharing and participation in research.
REFERENCES
China News (2008) [Rapidly increasing prevalence of diabetes in China.] (In Chinese) Available from: http://tinyurl.com/yfnwsfz (accessed 26.10.09) International Working Group on the Diabetic Foot (2003) International Consensus on the Diabetic Foot and Practical Guidelines on the Management and the Prevention of the Diabetic Foot. International Diabetes Federation, Amsterdam Xu Z (2007) The diabetic foot in China. 5th International Symposium on the Diabetic Foot, 9-12 May 2007, Noordwijkerhout, The Netherlands
First, artificial intelligence trumped expert chess players at their own game. Then came Watson, a computer system that famously beat Jeopardy! champions Brad Rutter and Ken Jennings. Now, researchers are putting artificial intelligence to work to automate biological research—-specifically the reverse engineering of metabolic networks from experimental data.
A team of scientists from Vanderbilt University, Cornell University, and CFD Research Corp. have shown that a computer can take raw experimental numbers from a biological data and derive equations from it that describe how the system functions. The modelling used in the research is said to be one of the most complex scientific modeling problems that artificial intelligence has solved completely from scratch.
Check out the announcement from Vanderbilt University:
The “brains” of the system, which [Vanderbilt professor John P. Wikswo] has christened the Automated Biology Explorer (ABE), is a unique piece of software called Eureqa developed at Cornell and released in 2009. [Michael Schmidt and Hod Lipson at the Creative Machines Lab at Cornell University] originally created Eureqa to design robots without going through the normal trial and error stage that is both slow and expensive. After it succeeded, they realized it could also be applied to solving science problems.
One of Eureqa’s initial achievements was identifying the basic laws of motion by analyzing the motion of a double pendulum. What took Sir Isaac Newton years to discover, Eureqa did in a few hours when running on a personal computer.
In 2006, Wikswo heard Lipson lecture about his research. “I had a ‘eureka moment’ of my own when I realized the system Hod had developed could be used to solve biological problems and even control them,” Wikswo said. So he started talking to Lipson immediately after the lecture and they began a collaboration to adapt Eureqa to analyze biological problems.
“Biology is the area where the gap between theory and data is growing the most rapidly,” said Lipson. “So it is the area in greatest need of automation.”
Wikswo believes that artificial intelligence could potentially be harnessed to generate and analyze biological data to such a degree that it could predict the behavior of biological systems under a variety of conditions.
[Wikswo also] maintains that this approach will give scientists the ability to control biological systems even if [the researchers] can’t completely explain how they work, and this capability can provide the basis for the development of significantly improved drugs and other therapies.
According to Cornell professor Hod Lipson, the researchers might need to create another program to translate the meaning of the equations that the Eureqa program comes up with.
This this video from a couple of years ago explains how the Eureqa software derived the fundamental equations of motion from observations of a double pendulum.
Top image: The microformulator pictured enables the biological experiments to be performed without human intervention. Image credit: Wikswo Lab.
Department of Biostatistics and Epidemiology and the Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
OBJECTIVE Lower-extremity amputation (LEA) is common among persons with diabetes. The goal of this study was to identify geographic variation and the influence of location on the incidence of LEA among U.S. Medicare beneficiaries with diabetes.
RESEARCH DESIGN AND METHODS We conducted a cohort study of beneficiaries of Medicare. The geographic unit of analysis was hospital referral regions (HRRs). Tests of spatial autocorrelation and geographically weighted regression were used to evaluate the incidence of LEA by HRRs as a function of geographic location in the U.S. Evaluated covariates covered sociodemographic factors, risk factors for LEA, diabetes severity, provider access, and cost of care.
RESULTS Among persons with diabetes, the annual incidence per 1,000 of LEA was 5.0 in 2006, 4.6 in 2007, and 4.5 in 2008 and varied by the HRR. The incidence of LEA was highly concentrated in neighboring HRRs. High rates of LEA clustered in contiguous portions of Texas, Oklahoma, Louisiana, Arkansas, and Mississippi. Accounting for geographic location greatly improved our ability to understand the variability in LEA. Additionally, covariates associated with LEA per HRR included socioeconomic status, prevalence of African Americans, age, diabetes, and mortality rate associated with having a foot ulcer.
CONCLUSIONS There is profound “region-correlated” variation in the rate of LEA among Medicare beneficiaries with diabetes. In other words, location matters and whereas the likelihood of an amputation varies dramatically across the U.S. overall, neighboring locations have unexpectedly similar amputation rates, some being uniformly high and others uniformly low.
Dr. Aaron I. Vinik on Early Insulin Use in the Progression of Diabetes
One of the leading diabetes researchers in the world, Dr. Aaron I. Vinik, Director of Research and Neuroendocrine Unit, EVMS Strelitz Diabetes Research Center, shares his views on early insulin initiation.
The natural history of type 2 Diabetes (T2DM) is a progressive worsening of glycemic control as a consequence of progressive beta cell failure so that ultimately all patients with T2DM are equivalent to patients with type 1 DM and are insulin deficient. In addition the clock starts ticking for macrovascular complications such as heart attacks, strokes and peripheral vascular diseases before the advent of fasting or postprandial hyperglycemia indicating that there are, in addition to hyperglycemia, a host of risk factors conducive to macrovascular disease. In contrast, the glycemia milieu is the single most important determinant of microvascular complications
Major studies in T2DM have indubitably shown a reduction of microvascular complications by good glycemic control and the effect persists despite failure to maintain A1c's near normal. This is in stark contrast with the recent attempts to show that intensive glycemic control in the ACCORD, ADVANCE and VADT studies reduce macrovascular events: somewhat disconcerting was the finding in the ACCORD study of an increase in sudden death by 22% in the intensively treated group. Thus, the window of opportunity to aggressively treat T2DM is early and patients can enjoy a 'legacy effect' or what has been reported as metabolic memory. Why then did we not see this benefit in the three studies above and what have we learned? The lessons were invaluable and suggest that there can be a bad metabolic memory or legacy effect in certain situations:
1. If the diabetes has been there for > 12-15 years;
2. Older people and African Americans;
3. Significant impairment of renal function;
4. The presence of coronary calcification;
5. The history of peripheral neuropathy and the findings of autonomic neuropathy.
So the window of opportunity has to be early in the absence of kidney, somatic and autonomic dysfunction, established cardiovascular disease and there are gender and ethnic group sensitivities. Perhaps the only protective factor appears to be obesity but that is almost contrary to everything we are trying to achieve in T2DM.
So armed with this information, why is it that we have developed a treat-for-failure approach trying several medications, diet and exercise and only when we have failed to reach goal do we make adjustments? The median delay of adjusting a sulfonylurea is 24 months and metformin is 36 months. Titration is a tardy task and treating for failure is doomed to failure. A fundamental change in physicians' management of T2DM is required and the traditional treatment algorithm should emphasize treatment for success not failure.
Traditional oral hypoglycemic agents such as sulfonylurea, metformin, the glitazones and the Incretins and Gliptins are able to lower A1c's about 0.5 to 2.0 %. Combinations of these agents can under optimum conditions achieve an A1c reduction of 3%. Thus in people close to goal of 6.5% (AACE) or 7.0% (ADA) then exercise, diet and a single agent are appropriate. If the A1c is between 7.5% and 9.0%, combinations of oral agents are an appropriate first choice. When A1c is > 9.0 we need the unlimited capacity of insulin to achieve goal. This can be accomplished in a number of ways which include addition to the oral regimen, use of a single long acting insulin analog, use of combinations of different forms of insulin and finally a basal long acting insulin together with a short acting bolus based upon the prevailing blood glucose and the anticipated carbohydrate intake. Data from the UKPDS indicate that after insulin is introduced either alone or in combination with oral therapy, the long term outcome is improved glycemic control. There is however a clinical inertia amongst generalists and even endocrinologists to make these change.
The barriers to initiation of insulin therapy are legion. Physicians have a fear of hypoglycemia and imagine there are adverse health consequences of the insulin itself. They have misconceptions of the regimens as being too complex and that it should be the therapy of last resort or limited efficacy. They are indeed major contributors to the fear patients have of the needle. This is a paradox when the needle per se is more benevolent than, for example, a finger stick. Patient-related behaviors are fear of hypoglycemia, adverse health outcomes, medication errors, needles and pain, weight gain and the complicated regimens and scheduling of injections. Unfortunately patients have been brainwashed into thinking that use of insulin is a personal failure, their disease is too advanced, it is the therapy of last resort and it greatly increases cost. Our own studies comparing insulin with oral agents have shown that insulin is associated with improved quality of life, less fatigue, increase in energy and enhanced state of emotion. Patient education along with the use of insulin formulations that reduce risk of hypoglycemia and weight gain, simplified treatment regimens and easy to use insulin delivery systems, should help to reduce the barriers to early aggressive insulin use when the window of opportunity presents itself and clinicians need to overcome inertia and not allow the window to close upon them. Every day here at the EVMS Strelitz Diabetes Center we see patients who are grateful for the restoration of their quality of life as well as the anticipated reduction of the burden of diabetes complications.
Dr. Aaron I. Vinik has written five books, published more than 250 papers in medical journals, and is recognized as a pioneer and scholar. Dr. Vinik has received research funding for his studies from the National Institutes of Health, the National Cancer Institute, the Kroc Foundation and the American Diabetes Association. He is a leader in research on the diagnosis and treatment of diabetic neuropathy with a particular expertise in the area of autonomic diabetic neuropathy, a complex and challenging condition. Dr. Vinik has also been a leader in research on new approaches to generate islet cell tissue from pancreatic duct tissue which may one day lead to a true cure for diabetes.
Proper preparation of the wound bed is essential to priming the wound for effective healing. Accordingly, this author discusses key principles from the literature and shares insights from his clinical experience in employing debridement and adjunctive modalities to help facilitate better wound healing and eventual wound closure.
Wound bed preparation is a term that describes making the wound ready for closure by advanced means. If the wound is not properly prepared, even the most expensive products or devices are unlikely to produce a positive outcome. One does not usually perform wound bed preparation in a single visit. There is more of a process to prepare the wound to be closed. In addition to the wound itself, one must ensure the patient is prepared for wound closure.
Podiatric physicians must manage infection, ensure adequate vascularity and remove external pressure from the wound.1 One can confirm the patient’s vascular status via noninvasive testing since pedal pulses alone are not a good indicator of sufficient perfusion. If there is vascular impairment, podiatrists should consider an appropriate referral for an intervention to improve circulation.
In regard to infection, patients with diabetes do not often mount systemic responses to infection. Therefore, clinicians must rely upon local signs. Is there erythema, purulent drainage or odor present? As infection is purely a clinical diagnosis, a culture cannot determine if the wound is infected. Cultures can only help to discern which bacteria are pathogens in that infection. Uninfected wounds should not be cultured.
One can mitigate external pressure either by surgical intervention or by using devices such as a total contact cast or removable cast walker.2
Completing the above process and creating a good wound healing environment is considered the standard of practice in most communities. One monitors the wound over four weeks. If the wound area does not reduce by at least 50 percent in that time period, the wound is unlikely to heal in 12 weeks and one should employ advanced therapies.3 There are many advanced therapies, ranging from skin grafts and flaps to bioengineered tissues, but they all require the wound to be adequately prepared.
A Closer Look At Key Factors That Can Affect Wound Healing
Wound bed preparation consists of far more than just a debridement and, in some cases, may take weeks to accomplish. The goal is to optimize the wound in order to promote healing with advanced means and remove the barriers to healing. Let us first consider the inherent factors that are detrimental to wound healing like bacteria, senescent cells and hyperkeratotic tissue.
Bacteria. A wound is a break in the dermal envelope. It is usually contaminated by bacteria and may even have a biofilm present. Just because a wound is colonized does not mean that it is infected. If the wound becomes critically colonized with bacteria, an infection may develop. Researchers suggest that bacterial loads between 105 and 106 per gram of tissue in the wound bed may cause infection.4
However, more virulent organisms may cause infection at lower concentrations. Biofilm itself is detrimental to wound healing and will hinder the process, but infection causes tissue destruction. Biofilm is difficult to treat. At this time, only thorough debridement has proven to be a definitive treatment.
Senescent cells. Cellular dysfunction is common in diabetic foot ulcers and other chronic ulcers. Somatic cells can only divide 50 times before their DNA telomeres have shortened and they can no longer replicate full copies of the DNA. At that point, there should be apoptosis or programmed cell death.
In some diabetic wound healing models, researchers have shown that the apoptotic mechanism is impaired. They note that these old (senescent) cells continue to live in the wound but do not replicate or produce growth factors.5 The senescent cells impair the ability of the wound to heal.
Hyperkeratotic tissue. This hardened tissue forms along the wound periphery and its formation is accelerated by pressure, either direct forces or shearing forces. Bearing weight on the hardened tissue causes subdermal tissue trauma and hemorrhage. Hyperkeratotic tissue acts as a barrier to epithelialization. This tissue can also undermine and collect fluid and debris, thus increasing the risk for infection.
Using Debridement And Adjunctive Modalities To Prepare The Wound Bed
The main goal of preparing the wound bed is to provide a healing surface, which would accept a graft. While wound bed preparation involves debridement, this is more than just debridement. It also includes consideration of the aforementioned factors such as bacteria, cell senescence and hyperkeratotic tissue. Debridement removes devitalized or contaminated material from within or surrounding the wound. Selective debridement stimulates the repair process. There are various methods of debridement including surgical (scalpel), hydrosurgical (Versajet, Smith and Nephew), biosurgical (maggots), enzymatic or mechanical (wet to dry dressings).6
I have heard the axiom that debridement converts a chronic wound into an acute wound. However, acute and chronic are specifically terms that describe time. One cannot take a chronic wound that has been open for four months and convert it into an acute wound present for one day. However, I believe debridement can put an acute injury into a chronic wound, which may provide growth factors and speed healing.
For the purposes of wound bed preparation, surgical or hydrosurgical debridement is preferred. It can occur at the same time as grafting or precede grafting by up to a week. Use a scalpel to remove the wound margins, saucerizing the tissue, and then use a curette or hydroscalpel to debride the wound bed. The goal is to obtain a bleeding granular wound. If you are preparing a wound in the operating room for grafting, ensure that bleeding is under control prior to applying the graft in order to avoid a hematoma. Hematoma between the wound bed and the graft is a leading cause of graft failure. One should avoid electric cautery, if possible, and employ pressure, epinephrine or thrombin if needed
If the wound is not completely granular, one should consider using either platelet-derived growth factor (PDGF, Regranex, Healthpoint Biotherapeutics) or negative pressure wound therapy (NPWT, VAC therapy, KCI) to make the wound granular and level with the surrounding tissue. The VAC therapy works well in combination with debridement to prepare the wound for grafting. VAC therapy can also assist in managing wound exudate. If one uses VAC therapy in the OR setting, ensure that bleeding is under control before applying NPWT.
Armstrong and Lavery studied 162 patients as part of a 16-week randomized clinical trial.7 As part of the study, 77 patients received NPWT while 85 received standard moist wound care. They found that VAC therapy had a faster rate of developing granulation tissue in comparison to standard moist wound therapy.
When choosing a biomaterial, foam is more effective than gauze at producing granulation tissue. Foam also compresses and contracts better than gauze, enhancing the wound’s ability to contract. Employing a silver impregnated foam can help manage bioburden.
When performing wound bed preparation a week prior to applying bioengineered tissue, one should perform an adequate debridement, saucerize the margins and promote a good wound healing environment with regular dressing changes until applying the tissue.
The first photo on page 1 shows two wounds on the lateral surface of a foot that are fibrotic but uninfected. We performed debridement with a scalpel and curette, which uncovered a healthy bleeding base (see the second photo on page 1). The use of bioengineered tissue prepared the wound for grafting. This preparation occurred in a single stage. One can apply a silver dressing to the wound to manage bacterial load and prevent infection until the application of bioengineered tissue.
Often, the wound requires a maintenance debridement at the time of grafting and during subsequent applications. Cardinal and colleagues retrospectively analyzed the results from two controlled, prospective, randomized trials of topical wound treatments on 366 venous leg ulcers and 310 diabetic foot ulcers over 12 weeks.8 The study results suggest that frequent debridement of diabetic foot and venous leg ulcers may increase wound healing rates. Maintenance debridements usually involve removing any obvious debris, fibrosis or hyperkeratotic margins.
In some cases, the purpose of bioengineered tissue application might be to aid wound bed preparation because the cellular therapy provides the wound with multiple growth factors.
Case Study: When There Is An Ankle Wound With Exposed Tendon
A 71-year-old male with diabetes presents to the clinic with a small, painful, undermining wound on the anterior ankle with an exposed extensor digitorum longus tendon. The wound was caused by direct trauma from a water sprinkler head. The tendon was visibly moving in the wound when the patient dorsiflexed and plantarflexed the ankle. This is problematic because bacteria has access to the tendon and can spread to adjacent compartments. The moving tendon also prevents granulation tissue from adhering.
The patient went to the operating room for a wide debridement and I removed all undermining tissue. The patient was admitted to the hospital
We started the patient on a VAC Ulta, a new product by KCI that instills a fluid into the wound. In this case, I infused one-quarter strength Dakin’s solution for the anti-infective and anti-inflammatory properties. With the VAC Ulta, one can tightly control the infusion/suction rate. I set this to instill 50 mL of Dakin’s solution, hold for five minutes, then resume suction and repeat the process every two hours.
After three days, the wound appeared to improve but the tendon was still exposed. The patient went back to the OR, where we performed debridement with a Versajet. I placed Integra (Integra Life Sciences) on the wound and used traditional VAC therapy with the Granufoam Bridge Dressing as a bolster. The patient wore a total contact cast (TCC-EZ, MedEfficiency) to keep the tendon from moving under the graft. I changed the TCC-EZ and VAC therapy twice per week. After two weeks of treatment, the wound became granular and the tendon was covered.
The aforementioned process describes wound bed preparation. I debrided the margins with a scalpel and performed light debridement of the wound bed with a Versajet. A split thickness skin graft was harvested from the anterolateral ipsilateral thigh at a thickness of 0.020 inches. I meshed this at 1:1.5 ratio, placed it on the wound and stapled it in place. I used a Mepitel silicone dressing (Molnlycke) as an interface. I placed VAC therapy on the graft as a bolster dressing and set this to -125 mmHg continuous pressure for five days.
After VAC therapy removal, I covered the wound with Mepilex Ag (Molnlycke) at that point. The graft interstices healed in about 10 days. I covered the donor site with a Mepilex Border (Molnlycke) and changed it as needed. The wound healed uneventfully.
Final Words
Proper preparation of the wound bed is vital to graft or tissue success. Wound bed preparation is much more than just a debridement and takes into account factors that impede wound healing.
By creating a recipient wound bed that is well vascularized, free from infection and granular with even sloping margins, we can increase the chance of graft take and facilitate more reliable wound healing.
Dr. Rogers is the Associate Director of the Amputation Prevention Center at Valley Presbyterian Hospital in Los Angeles
1. Rogers LC, Bevilacqua NJ. Organized programs to reduce lower-extremity amputations.J Am Podiatr Med Assoc. 2010;100(2):101-104. 2. Armstrong DG, Boulton AJ. Pressure offloading and “advanced” wound healing: isn’t it finally time for an arranged marriage?Int J Low Extrem Wounds. 2004; 3(4):184-187. 3. Snyder RJ, Kirsner RS, Warriner RA, Lavery LA, Hanft JR, Sheehan P. Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes.Ostomy Wound Manage. 2010; 56(4 Suppl):S1-24. 4. Sen RK, Murthy N, Gill SS, Nagi ON. Bacterial load in tissues and its predictive value for infection in open fractures.J Orthop Surg. 2000; 8(2):1-5. 5. Rogers LC, Bevilacqua NJ, Armstrong DG. The use of marrow-derived stem cells to accelerate healing in chronic wounds.Int Wound J. 2008; 51(1):20-25. 6. Attinger CE, Bulan E, Blume PA. Surgical debridement: the key to successful wound healing and reconstruction.Clin Podiatr Med Surg. 2000; 17(4):599-630. 7. Armstrong DG, Lavery LA. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial.Lancet. 2005; 366:1704-1710. 8. Cardinal M, Eisenbud DE, Armstrong DG, et al. Serial surgical debridement: a retrospective study on clinical outcomes in chronic lower extremity wounds.Wound Rep Regen. 2009; 17(3):306-311.
For 100 years, the process of vascular anastomosis has largely been the same. Surgeons take a needle and thread and delicately suture together the walls of the blood vessel. Though literally sewing together blood vessels is a widely utilized surgical procedure, it isn’t without its issues. Intimal hyperplasia, a cell response to the trauma of the needle and thread, causes blood vessels to narrow which increases the risk of a blood clot or localized turbulence. Sutures may trigger an immune response that causes dangerous inflammation. Moreover, suturing becomes extremely challenging on blood vessels that are less than one millimeter in diameter.
Microsurgeons at Stanford University have developed a new method of vascular anastomosis that is safer and faster. The key ingredient in this new process is Poloxamer 407, a unique, FDA-approved polymer whose properties can be reversed by heating. In the case of vascular anastomosis, Poloxamer 407 is injected at the site where the blood vessels are to be joined, and the area is heated. The unique properties of Poloxamer 407 cause it to become elastic and solid when heated above body temperature. This causes both openings of a severed blood vessel to become distended, allowing surgeons to precisely join the openings together with Dermabond, a commonly used surgical sealant. After the blood vessels have been joined, a decrease in temperature causes Poloxamer 407 to dissolve harmlessly into the bloodstream.
The process has been successfully demonstrated on blood vessels as small as 0.2 millimeters. If successful, the process could ultimately improve patient care by decreasing amputations, strokes and heart attacks while reducing health-care costs.
A couple of days ago, we ran a blog post on an implantable oxygen sensor for monitoring tumor growth. In related news, researchers at Purdue University are developing an implantable device using a similar approach to treat tumors. But instead of monitoring oxygen, the device generates the gas in order to boost the effectiveness of chemotherapy and radiation treatment. The technology generates oxygen through water electrolysis.
The device targets tumors that are hypoxic, meaning having low levels of oxygen. Hypoxic tumors are difficult to treat using radiation therapy because oxygen amplifies the effectiveness of radiation by helping to form free radicals, which damage a tumor’s genetic material. “So the hypoxic areas [of tumors] are hard to kill,” says Babak Ziaie, a Purdue professor who led the research. “Pancreatic and cervical cancers are notoriously hypoxic. If you generate oxygen you can increase the effectiveness of radiation therapy and also chemotherapy,” he adds.
Ziaie reports that his father is a cancer survivor, who went through many rounds of painful chemotherapy treatment. “This is a new technology that has the potential to improve the effectiveness of such therapy,” he says.
In testing on mice, the research group showed the oxygen generators are effective in treating pancreatic tumors. Measuring less than one centimeter in length, the generators were inserted into tumors using a hypodermic biopsy needle.
Bruin Biometrics, LLC, a wireless health technology company, and researchers at UCLA have developed a device for measuring the risk of pressure ulcer formation. The Sub-Epidermal Moisture (SEM) scanner is a handheld device which measures the dielectric properties of the tissue being assessed and provides an estimation of the sub-epidermal moisture which is indicative of risk of decub ulcer formation. The SEM scanner is designed to overcome current difficulties with visual pressure ulcer assessments by detecting early pressure damage before it becomes visible on the skin surface.
The scanner is intended for use in a point of care environment and can wirelessly transmit measured data for storage and analysis on Bruin Biometrics’ proprietary back end system. The video below gives a nice overview of the early clinical work on SEM that led to the development of the system. It also has some nice technical info and shots of the device itself (techies scroll to 3:30). The SEM scanner was officially unveiled in April of this year and is expected to be commercially launched in the coming months.
Case Presentation and Conclusion: A Novel Therapy for Treatment of a Diabetic Ulceration by Conway T. McLean, DPM
Conway T. McLean, DPM Director of Podiatric Surgery Cottage Clinics Chicago, IL
A diabetic patient presented to the office with a common presenting complaint, a non-healing wound. Like so many individuals with diabetes, this particular patient's level of self-care (as well as their understanding of the disease) was somewhat lacking. A limb-threatening infection had developed of the left foot, due, at least in part, to inappropriate care. Relevant medical history included a five year history of a charcot foot deformity of the right tarsus.
The motor changes associated with this patient's neuropathy manifested in hammertoe deformities, which predictably led to a distal digit ulceration. A better informed diabetic would have sought care sooner, well before the ulcer had developed into osteomyelitis. Thus, a primary causative agent, it might be argued, was a lack of education.
The patient presented to the office three weeks after the development of the digital ulceration. He had received minimal care prior to his arrival, consisting of simple wet-to-dry guaze dressing changes.
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Ulceration at first post-op check following debridement of infected bone and non-viable soft tissue, appropriate wound care.
Physical Exam
Initial assessment naturally included evaluation of the wound, vascular status and neurological function, and radiographs. Arterial doppler studies revealed patent pedal vessels, although skin perfusion was reduced, likely due in part to excessive edema with induration of soft tissues. The ulceration itself was fairly typical for the clinical situation, with surrounding hyperkeratosis, the presence of mild amounts of purulence, and gross enlargment of the digit. No actual pain was reported by the patient secondary to neuropathy, nor were systemic signs of infection evident, as is so often the case with a localized diabetic infection.
Musculoskeletal exam revealed contracture of the lesser digits with increased pressures to the distal aspect of the 3rd digit left. As is the pathogenesis of this condition, mild, non-infectious erythema led to the development of hyperkeratosis. The insensate patient will experience minimal to no symptoms, and only attuned health care specialists will be aware of impending events.
Plain film radiographs revealed osseous changes consistent with osteomyelitis, including cystic changes, fragmentation and osteolysis.
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Digit after debridement and excision of osteomyelitic bone and one FREMS treatment.
Treatment Considerations
Unfortunately for many diabetics, the terrible triad of immunopathy, neuropathy and vasculopathy combine to create very real and formidable obstacles to healing. "We are held captive by the blood flow" is a very apt saying, and though this individual had sufficient large vessel flow, signs of inadequate perfusion due to microvasculopathy were noted, included hair loss and atrophic epithelium.. The most obvious and accepted therapies, which were utilized here, include debridement of necrotic bone and soft tissue, moist wound healing, and appropriate antibiosis.
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Ulcerated digit demonstrating progressive healing following seven FREMS treatments
Unique Treatment
Utilized in this case was a very new, unique form of electrical stimulation, which employs high negative potential, single-phase electric current pulses, with suitably modulated frequencies and very short durations. These pulses are regulated in frequency, intensity, duration and potential, and act on the surface as well as the deep tissues. FREMS (Frequency Rhythmic Electrically Modulated Stimulation) was designed to take advantage of the belief that the summation of sub-threshold electrical stimuli, conveyed through the skin proximal to a motor nerve in a non-invasive system, would induce composite motor action potentials in excitable tissues.
This is in stark contrast to a single, low-intensity impulse of brief duration, such as the one delivered by TENS. This is unable to overcome the dielectric skin barrier and thus will not excite the underlying nervous and/or muscle to elicit a recordable motor action potential (MAP). The signal of the FREMS is quite different. Through a specific sequence of weak impulses, with a rapid increase and decrease in pulse frequency and duration, there is a gradual recruitment of MAP in the stimulated tissues.
The patient's wound closed quickly and progressively, without interruption. An additional benefit to this patient was the associated improvement in sensorium. Because the therapy was utilized to treat the ulceration, it was performed unilaterally. The increase in sensation, as compared to the untreated side, was reported by the patient with signs including improved two point discrimination, vibratory sensation, monofilament detection. Also importantly, this benefit continued, with minimal loss, for eleven months.
The science and art of wound care has developed rapidly as a field of study in the last few decades. This is evidenced by the explosion of new products and materials now available. Many adjunctive treatments have been developed, with more recent advances including negative pressure wound therapy, hyperbaric oxygen therapy and biological living skin equivalents.
The FREMS device has been shown through numerous double-blind studies to have several significant and important effects. For example, there are changes in the perfusion velocity in the microcirculation, as well as inducing a long-acting increase in vasomotor activity (with significant changes noted at four months post treatment).
Some other effects are an increase in the release of growth factors including VEGF, increased blood flow and capillary density encouraging the formation of new granulation tissue. Additionally, there is a significant increase in nerve conduction velocity(MNCV) and a statistically significant reduction of pain after FREMS. On average, at the end of active treatment, MNCV was increased by almost 5 m/s; vibration perception threshold was reduced by more than 2 V; and the number of foot points insensitive to the Semmes–Weinstein monofilament was decreased.
In this case, healing progressed rapidly upon initiating the FREMS, while the usual armamentarium of antibiosis, appropriate debridement and proper wound care were employed. Osteomyelitic bone was resected during the course of FREMS treatments (typically consists of ten sessions). The presence of infection is not a contraindication to its use, and it seems likely that FREMS aids the process of bacterial eradication by increasing perfusion.
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Osteomyelitic metatarsal head excision site healing via secondary intention.
Immunopathy is an important component of the lower extremity problems experienced so frequently by people with diabetes. Yet vasculopathy and neuropathy may be considered the more devastating mechanisms, which lead so often to limb loss, disability, and a drastic reduction in quality of life. Those studies performed to date appear to indicate that we have a new and powerful tool that may significantly alter the natural history of this condition, leading to morbidity and mortality. No side effects or complications from it's use have been experienced, and though perhaps not all will experience such dramatic effects as this patient did, it appears certain that this modality has the potential to drastically change the outcomes of diabetic patient care and maintanence.
Sincerely,
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REFERENCES:
Barrella M, Toscano R, Goldoni M, Bevilacqua. Frequency rhythmic electrical modulation system (FREMS) on H-reflex amplitudes in healthy subjects. Eura Medicophys 2007, 43: 37-47.
Bevilacqua M, Barrella M, Toscano R et al (2004) Disturbances of vasomotion in diabetic (type 2) neuropathy: increase of vascular endothelial growth factor, elicitation of sympathetic efflux and synchronization of vascular flow (vasomotion) during frequency modulated neural stimulation (FREMS). 86th Annual Meeting of the Endocrine Society, p 321, P 2–61 (abstract)
Bevilacqua M., Baruffaldi L., Foddis L., Toscano R., Vago. Increase of Vascular Endothelial Growth Factor by Electrical Stimulation with High Varialbility in Frequency and Amplitude: a clinical study in non-insulin dependent diabetics with limb ischemia. 85th International Congress of Endocrine Society, Philadelphia, June 2003
Bevilacqua M. et al. – Increase of Vascular Endothelial Growth Factor (VEGF) by FREMS. A clinical study in Non-Insulin Dependent Diabetics with Limb Ischemia. Presented at ENDO 2003 – Endocrinology Society’s 85th annual meeting – Philadelphia.
Bosi E, Conti M, Vermigli C, et al. Effectiveness of a novel frequency modulated electro-magnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia 2005, 48: 817-23
Ciancia, et al. Diabetic plantar ulcer treated with an innovative thearpy - FREMS (frequency modulated electro-magnetic neural stimulation). Italian Society of Gerontology and Geriatics, Florence; Palazzo Congressi 9-13 November 2005
Combi F. Application of novel neuromodulation for skeletal muscle regeneration following chronic fobrosis process. The Rehabiliation of Sports Muscle and Tendon Injuries-Milano April 2004
Conti M., Peretti E., Cazzetta G., Folini L., Vermigli C., Galimberti G. Frequency modualted electromagnetic neural stimulation enhances cutaneous microvascular perfusion in patients with diabetic neuropathy. 42nd Annual Meeting of the European Association for the Study of Diabetes, Copenhagen Sept. 2006
Da Ros R., C. Vitale, R. Assaloni, A. Ceriello Neuromodulation FREMS in the treatment of diabetic peripheral arterial disease. 42nd Annual Meeting of the European Association for the Study of Diabetes, Copenhagen Sept. 2006
Facchini M.G., Mambelli E., Checchia G., Gaggi R., Santoro A., The Lorenz Therapy: a new tool in the treatment of uremic neuropathy. European Dialysis and Transplant Association, Lisbona May 2004.
Farina S., Casarotto M., Benelle M., Tinazzi M., Fiaschi A., A randomized controlled study on the effect of two different treatments (FREMS and TENS) in myofascial pain syndrome. EUR MED PHYS 2004; 40:293-301
Guggi S, Cavina U. Experience of a novel transcutaenous neuromaodulation as first approach to muscle injuries. XIV International Congress on Sports Rehabilitation and Traumatology, Bologna 2005
Kumar D, Marshall HJ (1997) Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulation. Diabetes Care 20:1702–1705
Scionti L., Conti M., Vermigli C., Cazzetta G., Galimberti G., Bosi E. A new treatment for painful diabetic neuropathy: the Frequency Modulated Neural Stimulation (FREMS). NEURODIAB, Resensburg, Germany
Zhao M. Bai H, Wang E, Forrester J.V., McCaig CD. Electrical stimulation directly induces pre-angiogentic responses in vascular endothelial cells by signaling through VEGF receptors. J Cell Sci 2003:117.395-405.
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A partnership between the Mayo Clinic and the minds behind IBM's Watson technology is close to completing development of tools to mine data from electronic health records that speak different digital languages.
The goal is to "safely and securely convert stores of electronic health records into a bottomless pool of real-world clinical knowledge," the Mayo Clinic says in a news release. Reaching that goal requires the ability to glean information from a variety of EHRs that tag and store clinical information in different, often proprietary, digital formats.
So far, investigators with the Mayo-led team have used "natural language processing tools" to pull information from the records of 30 patients with diabetes and run it through computing systems developed with IBM's Watson Research Center, a process that transforms the data into 134 billion pieces of information, according to the clinic. (Watson is the language-recognition computer that recently won a Jeopardy! challenge against two of the game show's best human players.)
HHS believes that mining EHRs for clinical information can lead to improved care by allowing researchers to learn from trends and treatment successes across the country.
"This gets to the heart of meaningful use," says Lacey Hart, Mayo's SHARP administrator, in the news release. "It's one thing to meet the government requirement that you should have an electronic record, but it's another thing, once you have that record, to make meaning out of it."
The project is one of four funded by the $60 million Strategic Health ITAdvance Research Project (SHARP) program, an initiative of the U.S. Department of Health and Human Services through its Office of the National Coordinator for Health IT.
Decubitus ulcers are caused by pressure, sheer, and friction. The patient presented here had compromised blood flow. The additional pressure on the heel deformed the vascular bed and precipitated the necrosis/ischemia. If a decubitus ulcer is stable, my protocol is to evaluate the vascular status, hydrate anhydrotic skin, address any potential infections, optimize nutrition, offload the area (preventing friction and sheer), and have the patient ambulate if possible.
This 54-year-old insulin dependent diabetic was initially treated for a sterile bullae on the posterior aspect of the left heel. There was no precipitating acute trauma or thermal injury.
PAST MEDICAL HISTORY: This includes hypertension, diabetes, peptic ulcer and osteoarthritis.
MEDICATIONS: Catapres, Lovenox, Insulin, Zestril, Lisinopril and Reglan.
ALLERGIES: Percocet
FAMILY HISTORY: Diabetes, history of GI bleed.
SOCIAL HISTORY: Previous history of smoking, ceased more than ten years ago.
SURGICAL HISTORY: The patient has had left toe amputation, right ankle surgery times two, cholecystectomy and trigger finger release.
Activity Level
TREATMENT AND COURSE
After two weeks, the bullae dried into a gangrenous eschar with minimal moist necrosis in the deeper layers. The eschar was loosely adhered to the heel. The patient was seen weekly for debridement of devitalized tissue.
A L’Nard splint was utilized to offload the area. Home healthcare did daily assessments and applied enzymatic debridement agents with dressing changes.
This patient slowly developed a poor quality granulating base. Although there was some evidence of improvement, new areas of necrosis were seen. After some time, a component of the Achilles tendon could be visualized. Her pain level was between a 5 or 6 out of 10, giving a high suspicion that ischemia was a larger component of the problem than originally thought.
The patient was sent for a vascular evaluation. Peripheral flow to her leg was marginal at best. Stent placement would be considered, only if the wound would not heal, as patient was not an ideal candidate for surgical intervention. The arterial Doppler suggested partial occlusion of the femoral artery with calcifications in the distal branches.
Two months after the initial presentation, the patient came to the office with large bullae formation along the medial and lateral walls of the calcaneus.
Infectious Bullae Medial Wall (post debridement)
Bullae Lateral Wall (post debridement)
Moist necrosis Heel with MRSA
Erythema, fluctulance and drainage were readily apparent. Cellulitis and lymphangitis were noted. Cultures taken at that time indicated a MRSA infection.
The patient was admitted to the hospital and started on Vancomycin. An MRI indicated marrow signal changes in the posterior calcaneus compatible with osteomyelitis.
Standard x-rays showed loss of normal cortical structure.
MRI
Standard Radiograph
Hospital Admission
Upon admission, the patient’s WBC was 22, 000. Blood glucose was 360. Blood cultures were negative. After 48 hours, a partial calcanectomy was performed with wound debridement.
Postoperatively negative pressure wound therapy was initiated.
VAC in place
2nd Hospital Admission
During a subsequent hospitalization, stents were placed in the left leg. The quality of the granular bed improved markedly over the next two to three weeks.
Ultimately, a GRAFTJACKET® t was applied to the heel to further promote healing. Below is the most recent photograph showing the patient at one month status post surgery.
GRAFTJACKET® Applied
GRAFTJACKET® from KCI
One month post-op
Two month post-op
10 weeks post-op
At this point the options available to us are:
Hyperbaric Oxygen Therapy to promote further neovascularization
Debridement of undermined tissue with second application of synthetic skin
Debridement of undermined tissue with direct application of split thickness skin graft
Application of silver dressing to decrease bacterial load
Posted by: PV Mayer at 06:20 am 2 comments - Add a Comment Category: Diabetic Foot Ulcer Treatment
At this year's Desert Foot Multidisciplinary High Risk Foot Seminar (Nov 16- 18, AZ Grand Resort in Phoenix) we will be honoring a true legend with the inauguration of our Annual Paul Brand Memorial Lectureship. Some of you may have no idea who this remarkable man was (even though you all practice with the principles that he taught us). If you treat a neuropathic foot, you are approaching that high risk foot with the guidance that Dr Brand offered over his many years of practice and writings.
Paul Brand, MD 7/17/1914 - 7/8/2003
Paul Brand, MD (July 17, 1914 - July 8, 2003)was a Christian Missionary working in Vellore, India at a Leprosy Mission for many years (1946-1966). A trained Orthopaedic Surgeon, Dr. Brand, who grew up the son of English missionaries to South India, achieved world renown for his research on leprosy and related research on the dynamics of pain. He was a pioneer in developing tendon transfer techniques for use in the hands of those with leprosy (Hansen's Disease). He was the first physician to appreciate that leprosy did not cause the rotting away of tissues, but that it was the loss of the sensation of pain which made sufferers susceptible to injury.
Brand contributed extensively to the fields of hand surgery and hand therapy through his publications and lectures, and wrote popular autobiographical books about his childhood, his parents' missionary work, and his philosophy about the valuable properties of pain.
His book, Pain: The Gift Nobody Wants, one of several of his reflections on physiology, combines autobiography, stories of research, and reflections on pain and pain management. Indeed, still today we hear renowned lecturers use that same term to describe the affliction of diabetic persons with neuropathy — and how that loss of protective sensation robs them of the "gift of pain" that can protect their limbs from injury.
In 1966, after 19 years of service in India, he moved to the U.S.A. to become the Chief of Rehabilitation Branch at the National Hansen’s Disease Center at Carville, Louisiana. He worked there for 20 years and established a well-equipped and well-staffed research unit to study the complications of insensitive hands and feet, their prevention and management. During his time in Carville, he trained a number of podiatrists, physicians, and physical therapists and became well known for his understanding of neuropathic injuries to the lower extremities in leprosy as well as diabetic patients. He also introduced the concept of moderate repetitive stress (through his experiments on the footpads of mice) as the underlying etiology for the majority of neuropathic foot lesions.
His methods for prevention and management of plantar ulcers have subsequently been widely adopted for treatment of patients with diabetes mellitus. Brand reintroduced and popularized the Indian technique of total contact casting for effective offloading of the ulcerated neuropathic foot.
I first met Dr. Brand in 1978 as a new practitioner when I visited him in Carville to learn of his theories and principles. When he retired in 1986 from the U.S. Public Health Service, he moved to Seattle and continued his teaching as Emeritus Professor of Orthopaedics at the University of Washington. I again met him in Atlanta in 1996 at the American Diabetes Association Meeting, where he was awarded the prestigious Roger Pecoraro Award from the Foot Care Council, which I had the great honor to receive this year. His lecture on the Biomechanics of the Insensitive Foot was a stirring account of his life and research on neuropathic deformities and injuries. The lecture certainly warranted the standing ovation that he received after its delivery! My final encounter with Dr Brand was at the APMA National Meeting in Seattle in 2002, where he also was a guest speaker. The photo attached was taken at that meeting where you can see Paul Brand flanked by a much younger me (right) and the world renowned diabetic foot expert, Professor Andrew Boulton of Manchester, U.K.
Professor Andrew Boulton, Paul Brand and yours truly, Robert Frykberg at the APMA National Meeting in Seattle in 2002
It is most fitting that Professor Boulton receives the inaugural lectureship award named after Paul Brand this November 17th at our Desert Foot Meeting (AZ Grand Resort, Phoenix, AZ).. No one has taken up the mantle for the diabetic foot better than Andrew Boulton. More than any other person today, he is truly the International Ambassador for the Diabetic Foot around the Globe. Traveling to practically every Continent each year, Andrew tirelessly spreads “the Gospel” about the management of the neuropathic diabetic foot. Also a student and colleague of Dr Brand, Professor Boulton frequently mentions the “Gift of Pain ” as espoused by Dr. Brand in his lectures on neuropathy and diabetic foot disorders. The recipient of numerous accolades and awards for his work in this regard, Dr. Boulton has also been the recipient of the ADA’s Roger Pecoraro Award and the DFCON’s Edward Olmos Award.
Here’s an unusual story. As part of a “bio-art” project, Dutch artist Jalila Essaïdi collaborated with the Forensic Genomics Consortium Netherlands with the goal of developing bulletproof skin. To accomplish this, the scientists merged human skin cells with spider silk harvested from transgenic goats. In tests, the skin proved to be strong enough to stop a .22 caliber bullet fired at a reduced speed. It didn’t succeed, however, in repelling a bullet fired at full speed. Despite that setback, such skin could eventually be used for an array of medical applications, including burn and wound treatment, and tendon and ligament repair.
Vastly stronger than steel, spider silk is notoriously difficult to come by; harvesting the material from arachnids is complicated by the fact that the creatures are both highly territorial and cannibalistic. For that reason, the silk used for this application was made from genetically engineered goats that excreted silk protein in their milk.
The skin created for this project features a spider-silk matrix sandwiched between a dermis and epidermis layer.
The skin is on display at the National Natural History Museum in Leiden, Netherlands.
A video explaining how silk was harvested from milk from transgenic goats:
And for our Dutch speakers, here’s more about the silk with time at the gun range:
Artist’s description of the bulletproof skin: 2.6g 329m/s
Posted by: PV Mayer at 02:46 pm 2 comments - Add a Comment Category: Diabetic Foot Ulcer Treatment
Thanks to SALSA grad Tim Fisher for finding and tweeting this from his home in the UAE . It's work from Robert Gabbay from Penn State reviewed in MedPage today. Enjoy.
_________________
By Kristina Fiore
Diabetes patients enrolled in a medical home program supported by multiple payers saw improvements in several aspects of their care, researchers say.
A study of 10,000 patients who had been in the program for a year found that the percentage of patients who had yearly foot assessments for neuropathy rose from a baseline 50% to 69%, according to Robert Gabbay, MD, PhD, of Penn State University, and colleagues.
In addition, more patients got yearly screenings for nephropathy and diabetic retinopathy, and there was also an increase in pneumonia and flu shots over baseline, the investigators reported in the June issue of the Joint Commission Journal on Quality and Patient Safety.
Providers also made greater use of therapies shown to reduce morbidity and mortality: the proportion of patients on statins jumped from 36% to 57% after initiation of the program, while those on either an ACE inhibitor or an angiotensin receptor blocker (ARB) rose from 42% to 56% (P<0.05 for both).
Gabbay and colleagues lamented the fact that only 7% of diabetes patients currently achieve evidence-based goals for key predictors of morbidity and mortality, including glycated hemoglobin (HbA1c), blood pressure, and lower LDL cholesterol.
Further improvements likely require a paradigm shift, they said, which may be found in the Chronic Care Model incorporated into the Patient-Centered Medical Home.
The patient-centered medical home concept involves a team-based model of care, led by a primary care doctor who provides coordinated care throughout a patient's lifetime. The chronic care model focuses on multiple elements that enhance the relationship between patients with chronic conditions and their medical team, including greater support for self-management, improved clinical information systems, making community resources available, and offering decision support.
Gabbay and colleagues initiated one of the first medical home centers that incorporates the chronic care model for diabetes patients, initially encompassing 25 practices and 143 primary care providers covering about 10,000 diabetes patients in southeast Pennsylvania. Their model was unique, they said, because it incorporates multiple payers -- six of the state's private insurers.
Since there haven't been any data reported on this type of medical home, Gabbay and colleagues analyzed the program's first year, from May 2008 to May 2009.
During that time, they said they saw significant improvement in both evidence-based care guideline adherence and clinical outcomes.
Gabbay and colleagues also reported "small but statistically significant" improvements in key clinical parameters such as blood pressure and cholesterol, although they noted the greatest improvements occurred in the highest-risk patients:
An 8.5% absolute increase in the percentage of patients with an LDL cholesterol level under 130
A 4% absolute increase in those with blood pressure under 140/90
A 2.5% drop in the proportion of patients with HbA1c above 9%
They noted that said these effects may have been the result of the fact that the initiatives focused on high-risk patients in order to reduce the number of people with the poorest diabetes quality measures.
It's also possible that "some of the assessed performance improvement could be attributed to better data collection, documentation, and reporting," they wrote.
As well, improvements in complication screening resulted, in many cases, from distributing tasks among the healthcare team, they said.
The study was also limited by self-reported data, but overall the researchers said the program has already been expanded to include 152 practices and 644 providers.
Similar, multi-payer initiatives began after this initiative -- in Colorado, Rhode Island, and Vermont -- but Gabbay and colleagues noted that there are differences in their design and said it "will be important to understand how these differences affect the effectiveness of the patient-centered medical home efforts."
Superb article in today's Lower Extremity Review (online) by Cary Groner. He does a wonderful job in synthesizing works from a variety of research teams that come up with similar conclusions: if you don't use it, you lose it. Enjoy:
A classic case of innovative research turning conventional wisdom on its head is changing the way clinicians approach exercise in patients with diabetic neuropathy.
For decades, patients with type 2 diabetes and peripheral neuropathy were cautioned against weight-bearing exercise out of fear that the accompanying stress on the foot would lead to plantar ulcers. Then, in 2003, scientists began to report surprising findings.
"Prior to those studies, the feeling was that weight-bearing exercise was too risky to recommend to patients who lacked sensation," said Joseph LeMaster, MD, MPH. LeMaster, for many years an associate professor in the Department of Family and Community Medicine at the University of Missouri, will move to the University of Kansas this fall. "There was evidence that people with neuropathy had increased plantar pressures, and those were considered an independent risk factor for foot ulcers."
In 2003, LeMaster and his colleagues published a study of 400 diabetes patients with a history of foot ulcers and found that increased weight-bearing activity didn't increase the risk of reulceration. Moreover, the most active subjects saw the most significant risk reduction, and the effects were the same regardless of whether subjects retained foot sensation.1
That same year, researchers from Washington University in St. Louis reported in Clinical Biomechanics that diabetes patients with a history of plantar ulcers were 46% less active and accumulated 41% less daily stress on the forefoot than nondiabetic and diabetic control subjects without a history of such ulcers.2 At first, the finding seemed so counterintuitive that people weren't sure what to make of it. The authors ultimately concluded, conservatively, that subjects with a history of plantar ulcers were susceptible to injury at relatively low levels of tissue stress.
These studies flung open the door to further investigations, however. In 2004, scientists confirmed in Diabetes Carethat neuropathic patients who exercised more had lower rates of ulceration than those who were relatively sedentary.3 Two years after that, in 2006, researchers in Italy reported that, far from being deleterious, exercise could help prevent neuropathy's onset or modify its natural history.4 Right on cue, then, in 2008, Washington University researchers reporting on the Feet First study noted that promoting weight-bearing activity did not lead to significant increases in foot ulcers.5 Finally, in 2010, the American Diabetes Association, together with the American College of Sports Medicine, acknowledged this accumulating body of evidence and published new guidelines that, for the first time, endorsed weight-bearing exercise for patients with diabetic neuropathy in the absence of foot ulcers.6
"The new guidelines represent a big change," said Michael Mueller, PT, PhD, a professor of physical therapy at Washington University School of Medicine. "For the first time, people with diabetic neuropathy are explicitly encouraged to do weight-bearing exercise."
Although this rhythmic chronology outlines what appears to be a straightforward investigation that changed medical practice, the story is more nuanced. A number of questions have bedeviled researchers, and continue to. For example, what's the chicken and what's the egg? That is, do people get more ulcers because they get less exercise, or do they exercise less because of their ulcer history? Or, for that matter, are other variables involved that no one yet understands? These and other issues, such as how to distinguish those at highest risk of ulceration from their peers and how to adjust exercise regimens accordingly for individual patients, are only now starting to become clear.
Back in 2002, Mueller published a paper in Physical Therapywhose relevance to this issue was not immediately clear, but which turned out to have a big impact. In that article, he proposed a "Physical Stress Theory" (PST) of tissue adaptation, the premise of which was that changes in the relative level of physical stress cause a predictable adaptive response in biological tissues.7 In a nutshell, the theory suggests that tissues respond to stress in predictable ways: stress levels that are too low lead to reduced stress tolerance and atrophy; mid-level stress produces no change; moderately high levels increase tolerance; and too much stress leads to injury and tissue death. The goal for practitioners seeking to increase their patients' strength and resilience was to identify the levels that increased tolerance and work carefully from there.
Mueller also made several points that affected later researchers:
1. Stress exposure is a composite value comprising magnitude, time, and direction of stress application.
2. Extreme deviations from the maintenance stress range have serious consequences.
3. Individual stresses combine in complex ways to contribute to the overall level of stress exposure, and tissues are affected by the history of recent stresses.
4. Excessive stress can arise due to a brief, high-magnitude stress; a long duration of low-magnitude stress; or a repetitive application of moderate stress.
5. Inflammation occurs immediately after injury, reduces the injured tissue's stress tolerance, and requires that the tissue be protected from further stress until the inflammation subsides.
Many of these points turned out to be crucial to understanding how to manage diabetic neuropathy in the context of exercise.
Variability
The lead author of the 2004 study in Diabetes Care was David Armstrong, DPM, MD, PhD, professor of surgery and director of the Southern Arizona Limb Salvage Alliance (SALSA) at the University of Arizona College of Medicine in Tucson. An important aspect of his team's findings was not just that more active subjects were less prone to ulcers, but that variability in activity was an important predictor of ulcer risk. Eight of 100 patients with diabetic neuropathy ulcerated during the average evaluation period of 37 weeks, and although they were significantly less active than those who remained ulcer-free, there was also much more variability in their exercise levels, as measured by high-capacity computerized accelerometer/pedometers.
"People who had wide swings in activity were at greater risk," Armstrong told LER. "An example would be someone who's not very active, then suddenly remembers their grandkid's birthday and leaps off the couch, runs to the car, then spends an hour and a half walking around the mall. They do more in a couple of hours than they usually do in two days."
When Armstrong and his colleagues first evaluated their data, they were flummoxed.
"We sat there wondering what was going on," he said.
Their conclusion, however, echoed Mueller's observations about the importance of tissue stress levels and the consequences of extreme deviation in them.
"We believe what we're seeing is that it's just like a lot of other places in the body," Armstrong explained. "If you don't use it, you lose it. If skin is allowed to atrophy, then maybe it's weaker than skin that's getting tenderized, as it were, by frequent activity."
Armstrong noted that patients must be monitored carefully, as they were in his study, and that exercise has to be optimized for the individual.
"People can't run a marathon with profound neuropathy, but we'd like to try to train them so they could slowly become more active," he said. "We want to dose activity the way you'd titrate a drug."
As for the chicken-and-egg problem—which comes first, the ulcer or the lower activity levels?—researchers are continuing to probe the reasons first ulcers appear. Manish Bharara, PhD, a research assistant professor at SALSA and a colleague of Armstrong's, speculated that overall control of blood glucose levels may affect the resilience of damaged tissues.
"In diabetes patients, metabolic control affects other aspects of physiology, and could affect the quality of the tissue that is regenerated as someone heals," he said.
A couple of Armstrong's earlier papers may shed light on the issue, as well. In a 2001 article in the Journal of the American Podiatric Medical Association, Armstrong and his colleagues noted that diabetic patients with a history of neuropathy or ulceration took more steps per day inside the home than outside, and that only 15% of them wore their prescribed footwear inside.8 A paper in Diabetes Care in 2003 reported that subjects with foot ulcers wore their off-loading devices for only a minority of steps taken each day.9 Noncompliance with preventive footwear or curative devices could conceivably be similar in effect to low activity levels, then, in that both are associated with ulceration and poor healing. One possible explanation is that, compared to high-activity patients, low-activity patients are taking significantly fewer steps per day in footwear designed to help their feet avoid injury or heal (activity studies have not consistently reported compliance data).
"It even turns out that sometimes just standing for long periods can be potentially dangerous," Armstrong noted.10 "This is all about better identifying risk and helping us better coach activity. We're trying to get people moving, and in a lot of ways, that's how we measure success."
The Feet First study made it clear that clinicians must carefully consider the patient's history when prescribing exercise, according to lead author LeMaster.
"In that study, we felt that the exercise program, combined with the careful monitoring we conducted, showed that the benefits of exercise outweighed the risks," he said. "But it's quite another thing to say that people who have lots of recent foot ulcers should go out and do this. A good percentage of the people in the study had had prior ulcers, and we didn't find that to be a predictor [of ulceration during the trial]. But we restricted people from walking if they had any breakdown during the study."
People with a history of frequent and recurrent ulcers, he added, should be viewed in a different category than those included in the research. Furthermore, the study's subjects had their feet examined weekly by a physical therapist for the first three months, and had a hotline to call if they showed signs of ulceration later.
Mike Mueller, a coauthor of the 2008 Feet First paper, likened the evolving view of exercise in those with neuropathy to a similar evolution in thinking about exercise in cardiac patients a few decades ago.
"There was a time when the prevailing opinion was that if you'd had a heart attack, you should not exert yourself," Mueller said. "We came to learn that if you monitor the heart carefully and keep it within a safe range, exercise is beneficial. It's similar with the neuropathic foot, although we're still learning what the guidelines should be."
Adjusting exercise programs to the individual based on variables such as ulcer history is still an emerging field, he noted, and based both on the evidence provided by research and on clinical experience.
"I believe that once you've had a full-thickness ulcer, you're in a whole different category," he said. "Even a mild one sends up a red flag that you'd better watch this person. There's so much heterogeneity in the group of people who have diabetes and neuropathy that the program really needs to be tailored to the individual."
Joint biomechanics
Part of the problem with such tailoring is that only recently has research begun to describe the relationship between biomechanics and diabetic neuropathy.
For example, a 2007 paper in the Journal of Applied Biomechanics found that diabetic subjects with neuropathy had stiffer ankles than diabetic subjects without neuropathy.11 It's known that normal mobility allows the foot to flexibly dissipate impact, then become rigid during push-off.12 Restricted mobility in the foot and ankle joints, then, could hinder this transition and contribute to abnormal plantar loads.13
Citing such evidence, Smita Rao, PhD, an assistant professor of physical therapy at New York University, published a paper in 2006 outlining how changes in muscle could account for decreased range of motion (ROM) and increased stiffness in patients with diabetes.14 In a subsequent article inGait & Posture, she and her colleagues reported that decreased sagittal motion of the first metatarsal and lateral forefoot and frontal motion of the calcaneus were key elements that could contribute to increased, sustained plantar loading in patients with diabetes and neuropathy.15
"There's a big push to emphasize exercise in patients with diabetes and peripheral neuropathy, but those patients are also at higher risk for tissue breakdown, so I wanted to explore the mechanisms that put them at risk," Rao told LER. "We showed in the Gait & Posture paper that a lot of these patients try to reduce the effects of their stiffness by walking slower and taking shorter steps. When I examine them, I want to look at ankle range of motion, all the mechanical factors that may affect tissue breakdown; but I also want to assess how they walk, find focal regions of high pressure, then put those two together to see if walking is the best activity for this person. Some might need protective footwear, and some should ride a stationary bike instead."
In her current research, Rao and her colleagues at NYU are examining ways to bring a number of fields together.
"My grandfather had diabetes, so I have a personal connection to the field," she said. "All these negative effects begin with high blood sugar, so we're trying to combine medical, surgical, and rehabilitative interventions in patients with diabetes and neuropathy."
Exercise and balance
Other research has looked at the importance of augmenting exercise with balance training, which has been shown to improve clinical balance measures in neuropathic patients.16 A study published in Diabetes Care in 2010 demonstrated, moreover, that six weeks of such training reduced the risk of falls in 16 older patients with type 2 diabetes and mild to moderate neuropathy.17 In that research, exercise sessions included a balance/posture component (lower-limb stretches and leg, abdominal, and lower-back exercises) and a resistance and strength-training component using machines. The regimen led to better reaction times and affected sensory, motor, and cognitive processes, leading to a significant decline in risk of falls.
Lead author Steven Morrison, PhD, director of research in the School of Physical Therapy at Old Dominion University in Norfolk, VA, told LER that his group's work was motivated partly by the fact that older diabetes patients' risk of falling is 10 to 15 times that of healthy age-matched controls, which affects their confidence and ability to exercise.
"To be balanced, you need a certain amount of strength and a certain amount of coordination," he said. "We found that after six weeks of training, type 2 diabetic individuals become more like the control group—there's very little difference in terms of how much they sway and what their balance is like."
David Sinacore, PT, PhD, a professor of physical therapy and medicine at Washington University, and one of the researchers involved in studies of exercise and neuropathy there, emphasized that monitoring—by clinicians or the patients themselves—is crucial to successful exercise programs in those with diabetic neuropathy, particularly if they also have foot deformities such as those resulting from Charcot arthropathy.
"I'm a firm believer that these folks need to exercise for their diabetes," he said. "But if they start to develop lesions, they need to be addressed."
Of course, as most clinicians know, there is often a gap between ideal and real-world monitoring levels.
"It's hard for these patients to check the bottom of their feet regularly, so they sometimes don't do it," Sinacore said.
One way to help is with temperature monitoring. Sinacore recommends foot-temperature gauges that patients can use right after exercising, some of which are hook-shaped to ease plantar access.
"When we monitor them here, we check temperature before and after exercise," he said. "We're looking for hot spots and temperature differences that may indicate that they're developing a lesion."
In such cases, therapists recommend that patients decrease their exercise levels for a while and have their footwear modified to relieve pressure.
David Armstrong agreed that thermometry provides a way of keeping track of the damage caused by weight-bearing exercise.
"We want our patients to dose their activity by checking their skin temperature just as they dose their insulin by checking their glucose," he said.
His colleague, Manish Bharara, conducts innovative research in this aspect of care.18
"In the last decade we've learned that a four-degree difference between two similar sites on both feet is an ulcer risk," he said. "If the pattern persists over multiple days, the patient should reduce activity and immediately see a doctor."
Bharara and his colleagues are developing a thermometry scale to address some of the inconveniences typically associated with measuring foot temperature at several sites. Patients stand on it—it's similar to a bathroom scale—while it measures foot temperature at 20 sites on each foot and records the data. The scale speaks to the patient—telling him, for example, that his right big toe temperature is 5° warmer than the left. Moreover, if the scale detects an abnormal pattern for more than two days, it can be programmed to send a message to the physician's office and make an appointment.
"Something like this could really help manage patients' diabetes better, because the biggest barrier is compliance," Bharara said.
New research
Other researchers are examining variables that affect neuropathic patients' exercise capabilities, as well. For example, at the Center for Lower Extremity Ambulatory Research at Rosalind Franklin University in Chicago, Bijan Najafi, PhD, associate professor of applied biomechanics, has studied factors including gait initiation in this context.19 As opposed to the measures of steady-state walking—such as rate or number of steps—typically used in exercise studies, a prolonged gait initiation phase (the period between upright posture and steady-state gait) may be associated with increased fall risk.
"During the initiation of the step, there's an important acceleration phase, and it creates a lot of resistive force," Najafi said. "We've found that neuropathy patients have longer gait initiation. This makes sense, because to reach steady-state gait, people have to gather somatosensory feedback to find the speed at which they can walk safely and minimize energy costs. Neuropathy patients have impaired somatosensory feedback, though. But we believe that if we can provide a good exercise to compensate, we may be able to improve the gait initiation phase."
One way to help, Najafi thinks, is to take a cue from the dance world.
"If you're trying to explain a movement problem to a dancer he may not get it, but if you put a mirror in front of him and show him the correct position of the joints, he can improve his motor skills," he said. "The brain is plastic, and if it realizes there's an error, it will try to minimize it next time. So we hope that by letting neuropathy patients observe their errors this way, they may improve their motor skills."
Cary Groner is a freelance writer based in the San Francisco Bay Area.
References
1. LeMaster JW, Reiber GE, Smith DG, et al. Daily weight-bearing activity does not increase the risk of diabetic foot ulcers. Med Sci Sports Exerc 2003;35(7):1093-1099.
2. Maluf KS, Mueller MJ. Comparison of physical activity and cumulative plantar tissue stress among subjects with and without diabetes mellitus and a history of recurrent plan for ulcers. Clin Biomech 2003;18(7):567-575.
3. Armstrong DG, Lavery LA, Holtz-Neiderer K, et al. Variability in activity may precede diabetic foot ulceration. Diabetes Care 2004;27(8):1980-1984.
4. Balducci S, Iacobellis G, Parisi L, et al. Exercise training can modify the natural history of diabetic peripheral neuropathy. J Diabetes Complications 2006;20(45):216-223.
5. LeMaster JW, Mueller MJ, Reiber GE, et al. Effect of weight-bearing activity on foot ulcer incidence in people with diabetic peripheral neuropathy: Feet First randomized controlled trial. Phys Ther 2008;88(11):1385-1398.
6. Colberg SR, Sigal RJ, Fernhall B, et al. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association joint position statement. Med Sci Sports Exercise 2010;42(12):2282–2303.
7. Mueller MJ, Maluf KS. Tissue adaptation to physical stress: a proposed physical stress theory to guide physical therapist practice, education, and research. Phys Ther 2002;82(4):383-403.
8. Armstrong DG, Abu-Rumman PL, Nixon BP, Boulton AJ. Continuous activity monitoring in persons at high risk for diabetes related lower-extremity amputation. J Am Podiatr Med Assoc 2001;91(9):451-455.
9. Armstrong DG, Lavery LA, Kimbriel HR, et al. Activity patterns of patients with diabetic foot ulceration. Diabetes Care 2003;26(9):2595-2597.
10. Najafi B, Crews RT, Wrobel JS. Importance of time spent standing for those at risk of diabetic foot ulceration. Diabetes Care 2010;33(11):2448-2450.
11. Williams DS 3rd, Brunt D, Tanenberg RJ. Diabetic neuropathy is related to joint stiffness during late stance phase. J Appl Biomech 2007;23(4):251-260.
12. Saltzman CL, Nawoczenski DA. Complexities of foot architecture as a base of support. J Orthop Sports Phys Ther 1995;21(6):354-360.
13. Mueller MJ, Diamond JE, Delitto A, Sinacore DR. Insensitivity, limited joint mobility, and plantar ulcers in patients with diabetes mellitus. Phys Ther 1989;69(6):453-459.
14. Rao SR, Saltzman CL, Wilken J, Yak HJ. Increased passive ankle stiffness and reduced dorsiflexion range of motion in individuals with diabetes mellitus. Foot Ankle Int 2006;27(8):617-622.
15. Rao S, Saltzman CL, Yack HJ. Relationships between segmental foot mobility and plantar loading in individuals with and without diabetes and neuropathy. Gait Posture 2010;31(2):251-255.
16. Richardson JK, Sandman D, Vela S. A focused exercise regimen improves clinical measures of balance in patients with peripheral neuropathy. Arch Phys Med Rehabil 2001;82(2):205-209.
17. Morrison S, Colberg SR, Mariano M, et al. Balance training reduces falls risk in older individuals with type 2 diabetes. Diabetes Care 2010;33(4):748-750.
18. Bharara M, Cobb JE, Claremont DJ. Thermography and thermometry in the assessment of diabetic neuropathic foot: a case for furthering the role of thermal techniques. Int J Low Extr Wounds 2006;5(4):250-260.
19. Najafi B, Miller D, Jarrett BD, Wrobel JS. Does footwear type impact the number of steps required to reach gait steady-state?: An innovative look at the impact of foot orthoses on gait initiation. Gait Posture 2010;32(1):29-33.
New guidelines stress the crucial role that physical activity plays in the management of Type 2 diabetes: physicians should prescribe exercise....They replace recommendations made in the American College of Sports Medicine Position Stand, "Exercise and Type 2 Diabetes," issued in 2000.
Developed by a panel of 9 experts, the new guidelines are published concurrently in the December issue of Medicine & Science in Sports & Exercise and Diabetes Care.
"High-quality studies establishing the importance of exercise and fitness in diabetes were lacking until recently," the expert panel writes, "but it is now well established that participation in regular physical activity improves blood glucose control and can prevent or delay Type 2 diabetes mellitus, along with positively affecting lipids, blood pressure, cardiovascular events, mortality, and quality of life."
Most of the benefits of exercise are realized through acute and long-term improvements in insulin action, accomplished with both aerobic and resistance training, the experts write.
For people who already have Type 2 diabetes, the new guidelines recommend at least 150 minutes per week of moderate to vigorous aerobic exercise spread out at least 3 days during the week, with no more than 2 consecutive days between bouts of aerobic activity. These recommendations take into account the needs of those whose diabetes may limit vigorous exercise.
Sheri R. Colberg, PhD, writing chair, professor of exercise science at Old Dominion University, adjunct professor of internal medicine at Eastern Virginia Medical School, Norfolk, Virginia, and regular Diabetes In Control contributor, stated that, "Most people with Type 2 diabetes do not have sufficient aerobic capacity to undertake sustained vigorous activity for that weekly duration, and they may have orthopedic or other health limitations." "For this reason, the ADA [American Diabetes Association] and ACSM [American College of Sports Medicine] call for a regimen of moderate-to-vigorous activity and make no recommendation for a lesser amount of vigorous activity."
The panel specifically recommends that such moderate exercise correspond to approximately 40% to 60% of maximal aerobic capacity and states that for most people with Type 2 diabetes, brisk walking is a moderate-intensity exercise.
The expert panel also recommends that resistance training be part of the exercise regimen. This should be done at least twice a week -- ideally 3 times a week -- on nonconsecutive days. The panel also recommends that people just beginning to do weight training be supervised by a qualified exercise trainer "to ensure optimal benefits to blood glucose control, blood pressure, lipids, and cardiovascular risk and to minimize injury risk."
Regular use of a pedometer is also encouraged. In a meta-analysis of 8 randomized controlled trials and 18 observational studies, people who used pedometers increased their physical activity by 27% over baseline. Having a goal, such as taking 10,000 steps per day, was an important predictor of increased physical activity, according to the expert panel.
Finally, the new guidelines emphasize that exercise must be done regularly to have continued benefits and should include regular training of varying types.
Physicians should prescribe exercise, Dr. Colberg said in a statement. "Many physicians appear unwilling or cautious about prescribing exercise to individuals with Type 2 diabetes for a variety of reasons, such as excessive body weight or the presence of health-related complications. However, the majority of people with Type 2 diabetes can exercise safely, as long as certain precautions are taken. The presence of diabetes complications should not be used as an excuse to avoid participation in physical activity."
Type 2 Diabetes Treatment Intensification - by Ambro
Researchers look at how long it took doctors to intensify treatment for Type 2 diabetes patients who failed to hit improvement targets on metformin alone.
If you were diagnosed with Type 2 diabetes in the last ten years or so, your doctor may have advised a change in diet, monitoring of blood glucose levels, an occasional HbA1c blood test, increased physical activity, prescribing an anti-hyperglycemic oral medication, metformin, and follow-up visits. Treatment methods, of course, vary for many reasons.
If your treatment plan was somewhere along these lines, you were probably relieved you were not going to have to start right away with insulin shots, at least, not just yet. But what if the metformin did not work? When would it be time to try something different? Time to step it up a bit?
There are many articles and books discussing "treatment intensification" for Type 2 diabetes which refers to the point at which a patient's treatment is cranked up to the next level when the current treatment is not working. Some recent research has looked at treatment intensification and common care practice.
In August 2011 issue of Diabetes, Obesity, and Metabolism, Fu et al will report the results of their recent study of trends in treatment intensification related to Type 2 diabetes patients, specifically, those who fail to hit their improvement targets using "metformin monotherapy" (monotherapy refers to using only metformin as the diabetes-specific medication in a treatment plan). The patients in their study may have been prescribed additional medications to reduce hypertension and/or cholesterol, but this review is focusing on the metformin-related results primarily.
Where Did They Get The Data?
The team of collaborators from the Cleveland Clinic and NJ-based Merck affiliates was provided access to electronic medical record data on over 12 million patients from the humongous "General Electric (GE) Centricity" database.
Fu et al write that the GE database contains anonymous HIPPA-compliant clinical data entered by over 9000 medical providers, i.e., doctors, and includes demographic information, vital signs, laboratory orders and results, medication list entries, prescription orders, diagnoses, and medical problems." That's one comprehensive database. During your next office visit, you may notice a GE Centricity logo on the screen as your doctor patiently asks you questions and enters your responses in his computer.
The beauty of having this kind of data is that it can be sliced and diced in amazing ways to support medical research. With modern data analytic techniques, researchers can pose seemingly infinite questions and see if the data can support any correlations or conclusions.
To be considered for their study, your anonymous health records would have been in the GE database. Then you would have been at least 18 years old, diagnosed with Type 2 diabetes, on metformin as the only diabetes-specific medication for a given period of time, and had "at least one Hb1Ac resulting in 7.0% or greater or two fasting blood glucose measurements at or greater than 126 mg/dl," etc. They pinpointed patients who met their criteria between 1997 and 2008, which gave them over a decade of experience for their analysis. That period of time is referenced as the "index date" in their analytics.
Highlights Of Selection Criteria
Fu et al's report walks through their data slicing algorithms and highlights what they found. They looked at a population of over 12,000 patients in their study. The average age was 63 years old, and about half were women.
The average HbA1c in the group selected was 8.0% but included some over 9%.
Only 64% of patients who failed metformin monotherapy according to the study's criteria were progressed to more intensive treatment.
Reported Results
After crunching the numbers, the research team made several interesting observations, including:
Physicians seemed less inclined to initiate or intensify therapy in patients nearer a lower target HbA1c;
The average time patients followed their original metformin treatment plan was 14 months before "treatment intensification;"
There appeared to be some variance in the metformin-only diabetes treatment time and the dosage levels, i.e., patients who never exceeded 1500 mg of metformin had an average wait of 20.0 months before treatment intensification while those on higher dosages (46% in this study were prescribed 1500 mg or more) intensified in an average of about 9 months;
Overall, in U.S. clinical practices, treatment intensification has sped up in the more recent years of the past decade, e.g., doctors appear to be waiting less time to abandon metformin alone when test results are not satisfactory. The researchers suggest this indicates an improvement in diabetes care.
Reviewer notes that diabetics with uncontrolled or inconsistent test results, more than one medical condition (co-morbidity), or complications may not align with comparison to this review. In order to assess the effectiveness of any treatment and make decisions about intensification, the diabetic patient must be diligent in following doctor's orders, attending follow-up exams, monitoring progress, reporting any concerns, and asking questions.
This team suggests more studies can be done for further assessment of care. For more information, the American Diabetes Association publishes standards of medical care in diabetes.
Special Thanks to Dr. Alex Z. Fu, Associate Professor, Department of Quantitative Health Sciences, Cleveland Clinic, for sharing additional information to support this review.
Disclaimer: The information and links contained in this article are for educational purposes only and should not be used for diagnosis or to guide treatment without the opinion of a health professional. Any reader who is concerned about his or her health should contact a licensed medical doctor for advice.
Sources
American Diabetes Association. (2011, January). Standards of medical care in diabetes. Diabetes Care,Vol. 34, No. Supplement 1, S11-S61. Retrieved July 16, 2011, from organization website. DOI: 10.2337/dc11-S011.
Fu, A. Z., Qiu, Y. Y., Davies, M. J., Radican, L. L., & Engel, S. S. (2011). Treatment intensification in patients with type 2 diabetes who failed metformin monotherapy. Diabetes, Obesity & Metabolism, 13(8), 765-769. Retrieved July 14, 2011 from EBSCOhost online database. DOI:10.1111/j.1463-1326.2011.01405.x.
Jordan, J. (2010, November 5). The data analytics boom. Forbes.com. Retrieved July 16, 2011, from corporate website.
Lab Tests Online. (2011, June 17). Glucose. Retrieved July 16, 2011, from corporate website.
National Center for Biotechnology Information. (2011, May 16). Comparing newer drugs for diabetes including combination drugs. Retrieved July 16, 2011, from PubMed Health online database.
National Center for Biotechnology Information. (2010, June). Comparison of ge centricity electronic medical record database and national ambulatory medical care survey findings on the prevalence of major conditions in the united states Popular Health Management, 13(30), 139-50. Retrieved July 16, 2011, from PubMed Health online database.
National Center for Biotechnology Information. (2011, April 15). Metformin. Retrieved July 16, 2011, from PubMed Health online database.
National Center for Biotechnology Information. (2010, May 10). Type 2 Diabetes. Retrieved July 16, 2011, from PubMed Health online database
U.S. National Library of Medicine. (April 2011). HbA1c. Retrieved July 1, 2011, from Medline Plus online database.
We here at TMI prefer the recumbent bike but this great paper sheds some light on why people with diabetes don't exercise as much as they need to.
Why Do Patients with Diabetes Walk Less?
Physical activity is a cornerstone of treatment for diabetes, yet people with diabetes perform less moderate and vigorous physical activity (MVPA) than people without diabetes....Diabetes-specific barriers to physical activity are a possible explanation for lower MVPA in patients with diabetes. Some barriers that have been identified are "fear of hypoglycemia," the presence of "bad feet due to diabetes," and an "unwillingness to exercise in the presence of people who do not have type 2 diabetes." Other barriers include lack of social support, lack of knowledge of the types of exercise to perform, health problems, pain/difficulty taking part in exercise, lack of local exercise facilities, and aversion to exercising in poor weather. Regular walking activity is the preferred activity of people with diabetes.
The study compares adults' barriers to physical activity by diabetes status in a rural, population sample.
Walking is a preferred form of activity in diabetes, but people with diabetes walk less than people without diabetes, often citing fear of injury, according to the results of a study.
"In contrast, whether differences in walking activity exist has been understudied. Diabetes-specific barriers to physical activity are one possible explanation for lower MVPA in diabetes," the authors write. "We hypothesized that people with diabetes would perform less walking and combined MVPA and would be less likely to anticipate increasing physical activity if barriers were theoretically absent compared with people without diabetes."
From 2002 to 2004, 1848 randomly selected adult residents of rural Colorado were surveyed by telephone regarding their weekly duration of walking and MVPA. They were also asked about their likelihood of increasing their physical activity if each of 7 barriers was theoretically removed. Odds ratios (ORs) for persons with vs. without diabetes were adjusted for age, sex, body mass index (BMI), and ethnicity. "Less active" persons were defined as those who reported less than 150 minutes of weekly MVPA, and "more active" persons were defined as those who reported 150 minutes or more of weekly MVPA.
Compared with persons without diabetes, those with diabetes (n = 129) had lower odds of walking and MVPA for 10 or more vs. less than 10 minutes/week (walking-adjusted OR, 0.62; 95% confidence interval [CI], 0.40 - 0.95; MVPA-adjusted OR, 0.60; 95% CI, 0.36 - 0.99).
Fear of injury was reported to be a barrier to physical activity more often by respondents with diabetes than by respondents without diabetes (56% vs. 39%; P = .0002). However, adjustment for age and BMI attenuated this association (OR, 1.36; 95% CI, 0.93 - 1.99).
"Although walking is a preferred form of activity in diabetes, people with diabetes walk less than people without diabetes," the study authors write. "Reducing fear of injury may potentially increase physical activity for people with diabetes, particularly in older and more overweight individuals."
"Further research is needed to identify and overcome physical activity barriers for people with diabetes," the study authors conclude. "From a public health perspective, we need to identify key modifiable physical activity barriers that are related to physical activity levels in larger studies that are representative of the overall population with diabetes. The identification of key modifiable barriers should guide health policy decisions and the design of future behavioral intervention trials to increase physical activity for people with diabetes."
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
Osteomyelitis — Now What?
I n our last Foot Notes, we discussed one of the most vexing of problems in the diabetic foot - that of making the diagnosis of osteomyelitis. Vexing because this infection of bone is often present underlying deep foot ulcers, those of long duration, or those with frequent recurrences. To this date, there is no international consensus on what constitutes the best diagnostic method or modality, although bone culture and histopathology have long been considered to be the "gold standard". More likely than not, the diagnosis should probably be made by a composite of clinical and imaging findings, such as positive probe test and x-ray changes or deep infected ulcer with exposed capsule and positive bone/indium scans. Most importantly, this common complication of diabetic foot ulcers (DFU) should be looked for when ulcers do not respond to standard therapies as previously discussed in prior Foot Notes eZines. Once the diagnosis has been established, the real conundrum (some would say controversy) begins.
Is Osteomyelitis a Surgical or a Medical Disease?
In the USA, for instance, osteomyelitis has long been considered a "surgical disease" - one that required primarily surgical treatment with adjunctive prolonged antimicrobial therapy (usually parenteral). This has been taught in Medical School and surgical training programs for years. Unfortunately, this approach has been based on a customary treatment that likely began in the pre-antibiotic era. There is little data to absolutely support the necessity for surgery — including the total removal of the infected bone. However, even in general medical circles, there is a general consensus that debridement of dead bone or sequestra is necessary. Nonetheless, how much bone needs to be removed, when it needs to be removed, and how long antimicrobial therapy needs to be continued, remain undetermined.
The Surgeons Have It
As a surgically trained Podiatrist, I am of the opinion that osteomyelitis should primarily be treated surgically. I have too many patients who have had long standing DFUs treated with numerous courses of antibiotics who still failed to heal their wounds due to persistent underlying osteomyelitis (yes, they were also properly debrided and offloaded and yes, they were treated with culture guided antimicrobial therapy). Only when the underlying bone (or joint) was resected did they go on to fully heal. I certainly believe that when a diabetic foot joint is probed or when joint fluid exudes from a wound (and cultures positive), it needs to be resected, because there is little chance of cure without surgery. Resection, however, does not always imply amputation. If a toe is not gangrenous or ulcerated beyond hope, we do try to avoid amputation by performing a simple metatarsal-phalangeal (MTP) joint resection. Occasionally, a superficial bone debridement followed by culture driven antibiotics will be sufficient to cure the bone infection. For calcaneal osteomyelitis, we will attempt a partial calcanectomy with adjunctive use of parental antibiotics. Although not with highest quality evidence, many surgeons also prefer to insert antibiotic-loaded beads made of cement or absorbable calcium sulfate. The latter have the advantage of being resorbable, although they tend to drain for some time afterwards. The antibiotic-loaded cement beads have the disadvantage of needing to be removed at some point. I am aware of no comparative trials that suggest the addition of antibiotic beads has superior outcomes to bone resection alone. Of course, bone exposed in the presence of adjacent or contiguous gangrene meets the criteria for amputation in most clinicians' minds.
It's Medical Too
But what of primarily medical management with prolonged antimicrobial therapy for the proverbial six weeks administered parenterally? Most of us were also taught that the latter was the accepted course of therapy. And which agent is best? Are there any specifically indicated agents? Is oral therapy efficacious if it is culture directed? Unfortunately, there is little to no high quality evidence available to answer these questions. There have been no randomized trials for osteomyelitis (especially in the diabetic foot) comparing oral to parenteral therapy or one agent versus another in this regard. No one agent has been proven superior to another for the management of this condition. Nonetheless, our European and Canadian Medical colleagues certainly believe that osteomyelitis in the diabetic foot can be effectively treated with antimicrobial therapy without the need for surgery (except perhaps for superficial bone debridement). The problem with most such reports is that the diagnosis of osteomyelitis is uncertain, lacking bone biopsies and/or cultures in many cases. This raises the question as to whether there could have only been soft tissue infection present in those successfully treated patients. Although I must admit with some incredulity that I find medical therapy alone somewhat attractive (especially for our very sick or ischemic patients), I am not yet convinced that it can be effective in most cases of diabetic foot osteomyelitis (as opposed to hematogenous osteomyelitis in children).
My current protocol for management falls somewhere in the middle of these two opposing schools of thought. As mentioned, when I see a metatarsal head and cartilage exposed at the base of a wound, I instinctively schedule it for a joint resection and culture guided antibiotics. While starting initially with intravenous therapy, I am now more comfortable sending the patient home on oral therapy, if appropriate agents for the pathogen are available. Calcaneal osteomyelitis I will routinely treat as mentioned earlier (with or without beads). Generally, if I can see bony erosions on plain x-rays, I resect the bone (fully or partially) and treat with antibiotics until the wound has successfully healed. As is often the case in the diabetic foot, bone is probed, x-rays are negative, but bone scans or MRI are positive. In such cases, I am now attempting to treat with good wound care and culture guided oral antibiotics (unless there might be a good reason for parenteral therapy). For hemodialysis patients with MRSA bone infection, I might administer parenteral vancomycin after each dialysis session.
Granted, my approach is largely anecdotal, but based on years of experience and many failures. Given the equipoise between the two opposing ways to treat osteomyelitis, I think a healthy combination of the two is probably the best approach to follow. I eagerly await prospective comparative studies or randomized trials to answer some of the questions posed and the conundrum that we routinely face in practice.
References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on eTalk.
Best regards,
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
REFERENCES
Frykberg RG: An evidence-based approach to diabetic foot infections. American Journal of Surgery. 186 (Suppl 1):44-54, 2003
Frykberg RG, Wittmayer B, Zgonis T: Surgical Management of Diabetic Foot Infections and Osteomyelitis. Clinics Podiatr Med Surg. 24: 469-482, 2007
Thomas-Ramoutar C, Tierney E, Frykberg R : Osteomyelitis and Lower Extremity Amputations in the Diabetic Population. The Journal of Diabetic Foot Complications: 2010, 2 (1), No. 4, pp. 18-27.
Grayson et al: Probing to bone in infected pedal ulcers. JAMA March 1995 273: 721-723
Lozano et al: Validating the Probe-to-Bone Test and Other Tests for Diagnosing Chronic Osteomyelitis in the Diabetic Foot. Diabetes Care 33:2140–2145, 2010
Aragon-Sanchez J et al: Diagnosing diabetic foot osteomyelitis: is the combination of probe-to-bone test and plain radiography sufficient for high-risk inpatients? Diabet. Med. 28, 191–194 (2011)
Lavery L, Peters E et al: Risk factors for developing osteomyelitis in patients with diabetic foot wounds. Diabetes Research Clinical Practice 8 3 ( 2 0 0 9 ) 3 4 7– 3 5 2
Lipsky BA, Berendt AR, Deery G, et al: Diagnosis and Treatment of Diabetic Foot Infections. Clinical Infectious Diseases 2004;39:885–910
F. L. Game & W. J. Jeffcoate: Primarily non-surgical management of osteomyelitis of the foot in diabetes. Diabetologia (2008) 51:962–967
Products that help heal wounds tough to get to target market.
It's tough to bring any new product to market.
And when it's a healthcare product, requiring ministry approval, it's definitely a challenge. Maria Hayes explains in the final segment of her Open Wounds series. Enjoy Maria's last installment on the state of wound care in Hamilton.
Maria Hayes talks to Dr. Mayer about the state of affairs of DFU treatment.
In part 2 of her series on wound care, CHCH. reporter, Maria Hayes, explores further the etiology of diabetic foot wounds and some of the exciting and innovative new advanced treatment modalities that can help heel these devastating wounds. Enjoy.
Local Hamilton CHCH TV reporter, Maria Hayes, talks to Dr Perry Mayer about the devastating effects of diabetic foot wounds in the first of a brilliant 3 part piece on on the state of wound care in Ontario. Enjoy.
Brand described it and soon we will be able to see it, real time. As they say, you can't manage what you can't measure.
Heat sensitive bandage could combat infection
6 June 2011
Fibres used in the bandage can respond to changes in temperature. Image courtesy: Louise van der Werff/CSIRO
A bandage that warns of infection by changing colour has been developed by Monash University and CSIRO.
Lead inventor and Monash PhD student, Louise van der Werff said the bandage could lead to speedier and more effective treatments for chronic wounds, such as leg ulcers and bedsores.
“The bandage works by changing colour according to temperature,” Ms van der Werff said.
“Changes in temperature can indicate inflammation or suggest problems with blood supply, which can lead to infection. The bandage will help patients and clinicians with early detection, allowing them to treat any complications before they become serious.”
The cost of treating chronic wounds in Australia is estimated to be around $500 million each year. Prolonged, or chronic inflammation can delay and in some cases jeopardise the healing process.
“If problems are not quickly identified and treated, wounds can persist for months or years, resulting in a major reduction in quality of life. Not only that, the average cost of treatment is over $25,000 per wound,” Ms van der Werff said.
So far, the researchers have successfully developed the temperature sensitive textile, with the next step being to turn it into a full fledged bandage that will be commercially produced.
“The fabric we’ve created is sensitive to changes of less than half a degree Celsius. Patients and clinicians will be able to match the colour of the fibres with a calibrated chart that indicates the health of the wound,” Ms van der Werff said.
“Currently clinicians use electronic equipment to determine temperatures across the wound and surrounding tissue. We expect the bandage will deliver significant cost savings.”
Ms van der Werff is one of 16 early-career scientists recently chosen to present their research to the public through Fresh Science, a national program sponsored by the Australian Government.
As part of Fresh Science, Ms van der Werff will present her research during the next week at AMP’s Amplify Festival in Sydney, over dinner with Australia’s Chief Scientist in Melbourne, and to school students in Melbourne and Bendigo.
The devastating effect diabetes has on the lives, limbs and hip pockets of many Australians has now been fully exposed for the first time.
The Australasian Podiatry Council (APodC) has created the diabetic foot disease toll calculator, which shows the effect of diabetes on foot health in terms of hospital bed days, lower extremity amputations, deaths and costs in real time.
The left hand side of the calculator shows the consequences if the current system of diabetic foot health management in Australia is maintained.
The right hand side shows how the effects can be reduced with optimal foot health care.
APodC President, Andrew Schox says the calculator is a sobering reminder of the reality facing many Australians.
‘The fact is that improper foot health care is forcing many Australians with diabetes into our hospitals, where they may have a lower limb amputation or even die.’ Mr Schox said.
‘It’s a ludicrous situation when you realise that four out of five of these amputations may have been avoided if the patient had been given optimal foot health management’, Mr Schox continued.
‘At the moment patients with diabetes are only entitled to a maximum of 5 Medicare funded appointments with a podiatrist every year. In fact, many patients need around 12 appointments to reduce their leg wounds to avoid hospitalisation’.
‘The recent Federal Budget was billed as a cost-cutting budget, and yet it contained nothing about boosting the number of Medicare-funded podiatry visits for patients with diabetes.’
‘It would have been an excellent way to save money in the federal health budget. The research and this calculator show us that by spending more money on podiatry and foot care we can actually save the Australian taxpayer over $300 million each year. For example, a dozen Medicare-funded podiatry appointments for patients with diabetes costs a few hundred dollars, while lower limb amputations can cost the health system anywhere up to $100,000 per patient’.
‘It really is just simple maths – and in reality, the calculator shows not only the number of largely avoidable hospital admissions, but also the millions of tax-payer dollars that could have been saved.’ Mr Schox concluded.
To view the calculator, please go to this link: www.apodc.com.au
A great article from the folks at Diabetes-in-Control.
In 1970, the group Five Man Electrical Band released the hit single, "Signs," and in it there is a line, "Do This, Don’t Do That, Can’t You Read The Sign?" It seems that when it comes to food choices for diabetes patients the line should be, "Eat This, Don’t Eat That, Can’t you Read the Sign?" as every day someone else has a new miracle food to cure or prevent diabetes. Most of these health claims are suspect at best and often they are just a way for someone to make a lot of money. In this month's special edition we have looked over scores of articles, reports and health claims, to find the right things to eat and the right way to eat them. We have everything from almonds to zucchini -- and everything in between -- for you to share with your patients and unlike everyone else we let you know where the research came from and what the real effects might be.
David Joffe Editor-in-chief
Nuts
Acute and Second-meal Effects of Almonds in Prediabetes Inclusion of almonds in the breakfast meal decreased blood glucose concentrations… [ Full Story ]
Almonds Help Reduce Risk of Type 2 Diabetes and Cardiovascular Disease Incorporating almonds into your diet can help treat and possibly prevent Type 2 diabetes, as well as cardiovascular disease… [ Full Story ]
Fiber
More Fiber Reduces Cardiovascular and All-Cause Death Getting lots of dietary fiber appears to reduce the risk of dying -- particularly from cardiovascular, infectious, or respiratory diseases.… [ Full Story ]
Consumption of Diets High in Prebiotic Fiber or Protein during Growth Influences the Response to a High Fat and Sucrose Diet in Adulthood The data suggest that while a long-term diet high in protein predisposes to an obese phenotype when rats are given a high energy diet in adulthood, consumption of a high fiber diet during growth may provide some protection.… [ Full Story ]
Grains
Less Refined, More Whole Grains Linked to Lower Body Fat US researchers found that people who every day eat several servings of whole grains and limit intake of refined grains have less visceral adipose tissue or VAT, a type of body fat believed to trigger cardiovascular disease and Type 2 diabetes.… [ Full Story ]
White Rice Verses Brown Rice and Diabetes Risk Consuming more white rice appears to be associated with a higher risk for developing Type 2 diabetes, whereas consuming more brown rice may be associated with a lower risk for the disease.… [ Full Story ]
Whole Grain, Bran Reduces CV Mortality in Women with Type 2 Diabetes Women with Type 2 diabetes who ate more than 9 g of bran per day had a 35% lower risk for death from cardiovascular disease and a 28% lower risk for all-cause mortality compared with women who ate less bran, according to new study findings.… [ Full Story ]
Green Leafy Vegetables
Nitrates in Spinach Counteract Components of Metabolic Syndrome Nitrates reduce oxygen consumption during physical exercise; however, they are also of potential significance to diseases involving mitochondrial dysfunction, such as diabetes and cardiovascular disease.… [ Full Story ]
Green Leafy Vegetables Cuts The Risk of Diabetes by 14% A British meta-analysis found that increasing the daily intake of green leafy vegetables can reduce the risk of Type 2 diabetes… [ Full Story ]
Vitamins
Diabetes Risk Falls as Magnesium Intake Increases Getting enough magnesium in your diet could help prevent diabetes, a new study suggests. Consuming 200 milligrams of magnesium for every 1,000 calories reduces risk of diabetes by 47%… [ Full Story ]
Vitamin K Linked to Lower Diabetes Risk People who get plenty of vitamin K from food may have a lower risk of developing Type 2 diabetes than those who get less of the vitamin, a new study suggests.… [ Full Story ]
Antioxidants Increase Insulin Sensitivity A diet high in antioxidants may help increase insulin sensitivity and enhance the effects of metformin, according to a small study.… [ Full Story ]
Coffee
Why Coffee May Help Protect against Diabetes Coffee can give you a jump-start to the day but numerous studies have shown that it also may be protective against Type 2 diabetes… [ Full Story ]
Coffee Reduces Risk of Diabetes -- One More Study That cup of joe may be doing more than keeping you awake -- it also may be reducing your risk of developing Type 2 diabetes.… [ Full Story ]
Vinegar
Vinegar Reduces Postprandial Glycemia Vinegar, when taken regularly, can help manage diabetes, moderate food cravings and increase the body's absorption of calcium resulting to healthier bones.… [ Full Story ]
Dairy
Whole-Fat Milk and Cheese Can Lower Diabetes Risk The incidence of Type 2 diabetes declined significantly as levels of a fatty acid found in whole-fat dairy products increased… [ Full Story ]
Spices and Oils
Cinnamon for Diabetes: It Helps … a Little There may be no harm in adding cinnamon to your diabetes regimen, but does it really help?… [ Full Story ]
Why Fish Oils Can Improve Diabetes Control Researchers at the University of California, San Diego School of Medicine have identified the molecular mechanism that makes omega-3 fatty acids so effective in reducing chronic inflammation and insulin resistance… [ Full Story ]
Moderate Wine/Alcohol and Grapes
EASD: Moderate Wine Drinking Lowers Fasting Glucose in Type 2 Diabetes A glass of merlot or perhaps sauvignon blanc with dinner may offer modest benefits for patients with Type 2 diabetes, said researchers.… [ Full Story ]
Moderate Drinking Linked to 44%-65% Lower Diabetes Risk Adults who have a drink or two per day may have a lower diabetes risk than teetotalers and the link does not appear to be explained by… [ Full Story ]
Grapes Reduce Risk Factors for Heart Disease, Diabetes Findings show grape consumption lowered blood pressure, improved heart function and reduced other risk factors for heart disease and metabolic syndrome… [ Full Story ]
Moderate Drinking in Women Linked to Less Weight Gain Lu Wang, MD, PhD, from Brigham and Women's Hospital in Boston, MA, and colleagues write, "The obesity epidemic is a major health problem in the United States… [ Full Story ]
Fats
Bacon at Breakfast Healthier than a Bagel The age-old maxim "Eat breakfast like a king, lunch like a prince and dinner like a pauper" may in fact be the best advice to follow to prevent metabolic syndrome, according to a new study… [ Full Story ]
This author navigates the complex issues in treating an elderly patient with a heavily exudative diabetic foot ulcer, which has recurred over an 11-year period.
This case is compelling for several reasons. It illustrates the importance of the team approach to limb salvage in a complex case. It illustrates the importance of thorough vascular assessment, the need to biopsy and the utilization of advanced technologies. It also illustrates the disconnect in wound management between the home health industry and ordering physicians who do not closely follow their patients in the home setting and who typically have minimal expertise in wound care.
Lastly, it is a case that illustrates the impact of social dynamics in the home and how effective networking can positively affect outcomes. It is certainly not the most complicated case in the clinical sense but there are powerful and enduring lessons that one can take away from this case.
The patient is an 82-year-old male with a left foot ulcer, which was marked by healing and recurrence over an 11-year period. The initial evaluation of the ulcer occurred in the patient’s home June 13, 2006. His past history included heavy tobacco use of greater than 60 years and a recently diagnosed onset of type 2 diabetes.
The Director of Nursing (DON) for a home health agency went to the home of this patient to perform a final evaluation before discharging him. It was her first encounter with the patient although her agency had been following him for several months. Upon evaluating the patient, the DON found a patient who was not appropriate for the home care setting. The DON subsequently referred the patient to our practice.
Upon the initial examination in the patient’s home, our nurse practitioner noted a heavily exudative ulcer on the dorsum of his right foot. The patient was in exquisite pain and this pain became worse upon elevation of his lower extremity, which was cool to the touch. Maggots had infested the ulcer and there was an odor to the ulcer as well. The wound edges were irregular and there was obvious depth to the ulcer although one could not determine the full depth of the ulcer due to extensive debris and pain. The patient was afebrile.
The patient’s primary caretaker was his son, a Vietnam-era veteran who suffered from post-traumatic stress disorder. He told our nurse practitioner: “All they (the home health nurses) do is tell my father to elevate his legs but he can’t because he has too much pain.”
This author navigates the complex issues in treating an elderly patient with a heavily exudative diabetic foot ulcer, which has recurred over an 11-year period.
This case is compelling for several reasons. It illustrates the importance of the team approach to limb salvage in a complex case. It illustrates the importance of thorough vascular assessment, the need to biopsy and the utilization of advanced technologies. It also illustrates the disconnect in wound management between the home health industry and ordering physicians who do not closely follow their patients in the home setting and who typically have minimal expertise in wound care.
Lastly, it is a case that illustrates the impact of social dynamics in the home and how effective networking can positively affect outcomes. It is certainly not the most complicated case in the clinical sense but there are powerful and enduring lessons that one can take away from this case.
The patient is an 82-year-old male with a left foot ulcer, which was marked by healing and recurrence over an 11-year period. The initial evaluation of the ulcer occurred in the patient’s home June 13, 2006. His past history included heavy tobacco use of greater than 60 years and a recently diagnosed onset of type 2 diabetes.
The Director of Nursing (DON) for a home health agency went to the home of this patient to perform a final evaluation before discharging him. It was her first encounter with the patient although her agency had been following him for several months. Upon evaluating the patient, the DON found a patient who was not appropriate for the home care setting. The DON subsequently referred the patient to our practice.
Upon the initial examination in the patient’s home, our nurse practitioner noted a heavily exudative ulcer on the dorsum of his right foot. The patient was in exquisite pain and this pain became worse upon elevation of his lower extremity, which was cool to the touch. Maggots had infested the ulcer and there was an odor to the ulcer as well. The wound edges were irregular and there was obvious depth to the ulcer although one could not determine the full depth of the ulcer due to extensive debris and pain. The patient was afebrile.
The patient’s primary caretaker was his son, a Vietnam-era veteran who suffered from post-traumatic stress disorder. He told our nurse practitioner: “All they (the home health nurses) do is tell my father to elevate his legs but he can’t because he has too much pain.”
...........continued below
Posted by: PV Mayer at 04:06 pm 2 comments - Add a Comment Category: Diabetic Foot Ulcer Treatment
We admitted the patient to Specialty Hospital of Jacksonville on June 13, 2006. During the patient’s subsequent hospitalization, magnetic resonance imaging (MRI) and X-rays did not reveal bone marrow edema, osteolysis or deep abscess. Cultures revealed multiple bacterial organisms and infectious disease physicians prescribed IV antibiotics including vancomycin and Zosyn (piperacillin/tazobactam).
The medical management of the patient was under the direction of an internist. A biopsy of the ulcer revealed initial pathology, which triggered concern for a possible angiosarcoma. A pathologist recommended a second opinion to further assess the biopsy specimen.
When Revascularization Is The Keystone For Improved Healing
A vascular evaluation of the patient revealed multi-segmental occlusions of multiple arteries of the lower extremity, both proximal and distal to the popliteal artery. An interventional cardiologist performed subsequent revascularization using several endovascular methods including angioplasty, atherectomy, stent placement and cold laser.
The patient began showing rapid improvement after revascularization. This improvement started to happen while further evaluation of the biopsy specimen was occurring. The patient’s pain level decreased significantly after endovascular intervention and the ulcer responded to initial management that focused solely on regular cleaning. While awaiting the second assessment of the biopsy assessment, intensive wound care included daily pulsed lavage, IV antibiotics and an alginate dressing saturated with Dakin’s solution.
After approximately two weeks, the results of the biopsy ruled out angiosarcoma on July 5, 2006 in favor of a diagnosis of hypergranulation tissue.
With the wound now revealing an overall improvement marked by decreases in depth, pain, odor and an increase in granulation, we decided to apply Apligraf on July 7, 2006. The patient was discharged from the hospital to home on July 19, 2006.
Final Notes
Through home health care and our nurse practitioner’s home visits, the patient’s progress was followed after the hospital discharge. On October 25, 2006, the ulcer was resolved. We discharged the patient from our service.
The patient’s son began questioning the ethics of the interventional cardiologist, who had also found occlusions on the contralateral lower extremity and recommended further endovascular interventions as well as periodic monitoring of the left lower extremity. The patient’s son did not bring the patient to follow-up visits with the cardiologist as he verbalized the opinion that the cardiologist was only looking to “make money off” his father.
Eventually, the patient developed ischemic gangrene in his right lower extremity, which resulted in a below-knee amputation. The patient was admitted to a long-term care facility, where he has been residing since 2007. His left foot remains healed at the time of this writing.
Dr. Bell is a board certified wound specialist of the American Academy of Wound Management and a Fellow of the American College of Certified Wound Specialists. He is the founder of the “Save a Leg, Save a Life” Foundation, a multidisciplinary, non-profit organization dedicated to the reduction of lower extremity amputations and improving wound healing outcomes through evidence-based methodology and community outreach.
Posted by: PV Mayer at 04:02 pm 2 comments - Add a Comment Category: Diabetic Foot Ulcer Treatment
Podiatrist Tammy Gracen says two of her patients ended up having amputations because they were not able to afford the extra cost for preventative orthopedic care. CBC
A Vancouver podiatrist says provincial healthcare cuts are to blame for two amputations her patients have undergone over the past year and she is calling on the government to restore funding.
Dr. Tammy Gracen says when the province stopped funding orthopedic shoes and orthotics for cases where amputation wasn't deemed a risk in March of 2010, she had to switch from helping patients in pain, to leaving them in pain because they can't afford proper treatment.
Since then she has had one patient lose a toe, another had three amputations, with the last, below the knee, Gracen said on Friday morning at her Vancouver office.
She believes the amputations would have been preventable if treated earlier with preventative measures, but by the time orthopedic shoes were approved it was too late.
"I can't help. I just can't help, and that hurts," she said.
In addition Gracen says she's had a number of cases where patients are in pain because of poor circulation or other foot problems, but can't afford proper treatment.
"It's tough to look them in the eye. It makes me sick. Not just the amputations, but the ones in pain, and the children particularly," she said.
"Sometimes I do it out of pocket myself, because I can't stand it. It's too hard to look at."
Gracen wants a return to coverage for early intervention, and pain relief.
B.C. NDP Health Critic Mike Farnworth says it's costing taxpayers more in the long run.
"An idiotic cut, to save a few dollars -- the result is tragedies for people who are facing an amputation," said Farnworth.
The Health Ministry has not yet been reached for comment.
EDMONTON - A new survey suggests the struggle with obesity can be a significant financial burden for some Canadians.
Results released Tuesday by the Canadian Obesity Network indicate that among those who spent money on weight loss methods over the past year, the average amount spent was around $900 on commercial weight loss programs, $766 on gym memberships, about $600 on prescription diet pills and about $400 on special diets.
Nearly three-quarters of respondents say they have been battling their weight for more than 11 years, and about one-quarter say they've lost count of how many times they've tried to lose weight.
Almost half of the morbidly obese Canadians who took part say they've noticed an impact on relationships with their friends and family, and one in six say they've been diagnosed with depression or anxiety.
Dr. Arya Sharma, scientific director of the obesity network, says there's a misperception that obesity arises out of laziness or poor choices, but the survey results show that patients with severe obesity want to lose weight.
The network's online survey was conducted earlier this year with Leger Marketing, and involved a sample of 524 severely obese Canadians who are 18 or over. A severely obese person is defined as having a body mass index of 35 or over.
A sample of this size is said to have a margin of error of plus or minus 4.3 percentage points.
Sixty-seven per cent of respondents said they have not considered weight-loss surgery. Of those, 58 per cent cite the possible health complications and 46 per cent said they felt there were safer ways to lose weight.
Sharma said the survey results highlight the frustration that obese individuals feel as they struggle to lose weight with minimal success.
"The survey makes clear that Canadians are confused about where to go to find credible weight management resources," he said in a statement.
"Surgery wait times can be very long, the commercial weight loss industry is not regulated, so many of those products and services can be a waste of time and money, and employers are just coming around to the idea that obesity management has to move beyond simply telling people to eat less and move more," he said in a release.
"What Canadians with excess weight need most is clear guidance on how to find the help they need."
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
Osteomyelitis- Making the Diagnosis
I n this month’s issue, we will discuss an ostensibly difficult topic that we all face when managing patients with diabetic foot ulcers – that of underlying osteomyelitis(OM). Perhaps no other related topic is faced with as much consternation as is this. Osteomyelitis (bone infection) specifically refers to infection of the medullary bone as opposed to osteitis wherein the periosteum or cortical surface becomes infected through a penetrating wound or ulcer. Despite these differences, the two are clinically diagnosed or treated in much the same way. Having treated osteomyelitis (OM) associated with diabetic foot wounds for many years, I certainly recognize what a conundrum it can be for the clinician. Since both diagnosis as well as treatment can be clinically challenging, let’s just focus on its diagnosis this month. We’ll get to management next month.
Much has been written about the diagnosis of OM over the years and especially that which complicates diabetic foot ulcers (DFU).1-3 Whereas hematogenous osteomyelitis generally affects children, OM complicating the diabetic foot almost always arises from a contiguous penetrating wound or foot ulcer. There are several ways to classify OM, but the most popular way in academic circles is the Cierny-Mader classification that attributes both an anatomical (diffuse, localized, etc.) as well as host status (healthy, compromised, etc.) components.4Although this can be helpful in categorizing the bone infection, in the feet of patients with diabetes, osteomyelitis is usually chronic and difficult to effectively treat. Hence, early diagnosis becomes a critical factor in its successful management.
As in most disorders, clinical suspicion for this complication is paramount in making the diagnosis early. If one suspects OM or routinely makes an effort to investigate its presence (or absence), one is more likely to detect it when indeed present. Generally speaking, ulcers of greater duration, depth, or size have a higher likelihood of developing underlying OM. This has been confirmed in some studies and not corroborated in others, so these wound characteristics are not definitive markers. Nonetheless, it is always wise to suspect bone infection under indolent ulcers and particularly so in patients with peripheral arterial disease(PAD). A very important concept to introduce into our discussion at this point is that of prevalence or prior probability of the disease. Much has been made of prior probabilities in recent years, especially in the interpretation of diagnostic tests.5,6 For example, in the routine outpatient setting, one can expect to see relatively uncomplicated (healthy appearing) neuropathic DFUs. While I hesitate to use the term “healthy”, a neuropathic ulcer of fairly recent onset (let’s say 4 weeks in duration) that is superficial, granular, and well perfused without evidence of infection has a relatively low prevalence of osteomyelitis (perhaps 20% or so).6 Bayes theorem suggests that any diagnostic test will have a higher rate of false positive results when the prevalence of disease is low. Contrast the outpatient scenario above with that of
the inpatient setting wherein patients with acutely infected foot ulcers are admitted. These patients might also have associated PAD as well and by the nature of their active infection, their prevalence of associated osteomyelitis might be in the range of 66 to 95%, depending upon the study one relies upon.7,8,9Therefore, positive findings on clinical, laboratory, and imaging examinations are more likely “true” positives than false positive findings (unless there is an associated Charcot foot). Accordingly, when interpreting published studies, as always, we must be mindful of the patient population under study. This seemingly obvious fact has lead to most of the published controversy in ascertaining the accuracy of various diagnostic tests in this regard.
We are all well familiar with the role of various imaging modalities in the diagnosis of osteomyelitis and certainly, much has been written on them in the setting of the diabetic foot.10-12 While I will refer the reader to the list of references for detailed reviews of diagnostic imaging, let me briefly summarize the pros and cons of the more common modalities used in detecting OM complicating diabetic foot ulcers. First and foremost, we must always take Xrays . Plain radiography is readily available around the world, inexpensive and can provide essential information at the onset of patient contact. We look for foreign bodies, soft tissue swelling, gas, fractures, and erosions or periosteal new bone formation- the latter two being suggestive for osteomyelitis in the infected foot. Unfortunately, Xrays are very insensitive to OM because the visible changes are often delayed or the two dimensional image might not ascertain a focus of osteomyelitis under a central metatarsal head or calcaneus until very late in the course of the disease. However, when radiographic changes are evident directly under an ulcer with visible bone at its base, the diagnosis becomes highly likely. Three phase technetium (99mTc) bone scans, on the other hand, are highly sensitive scintigraphic scans, but suffer due to poor specificity, especially in the setting of neuropathy. Hyperemia of bone due to autonomic neuropathy, neuropathic bone changes, and minor stress fractures can result in false positive findings. Therefore, these bone scans are usually combined with leukocyte scans (i.e. indium scans) that are more specific (although not 100% accurate) for bone infection.
Figure 1. Plain Xray clearly showing osteomyelitis of the distal tuft of the hallux.
Figure 2. Bone scan showing osteomyelitis of the first MTP joint in another patient with a chronic ulcer under the 1st metatarsal head.
Figure 3.MRI of patient with a midfoot ulcer probing to bone and a Charcot foot. The diagnosis of osteomyelitis in this setting is less accurate.
MRI is presently considered to be the most accurate imaging modality to ascertain underlying osteomyelitis, especially when using special sequences (fat suppression) or contrast media (gadolinium). Nonetheless, in the presence of underlying neuropathic bone changes (Charcot arthropathy), the diagnosis of osteomyelitis becomes more difficult is certainly less accurate.11Computed tomography ( CT), SPECT, and PET/CT are also interesting modalities in this regard, but the latter are not yet widely available and there is not a lot of published data on their utility in the diabetic foot.10
For years, my most useful clinical examination technique has been the Probe-to-Bone (PTB) test.
Figure 4. The Probe to Bone test using a simple applicator stick. This is positive when bone or a hard, gritty surface is palpated.
First brought to the forefront by Grayson in 1995, this simple clinical evaluation technique yielded an 89% positive predictive value (PPV) in patients hospitalized with diabetic foot infections and a prevalence of osteomyelitis of 66%.5 As inferred earlier, the utility of this test has come under scrutiny, especially in the outpatient setting, because of the high prevalence of osteomyelitis in this hospitalized population. Another study that reported on the PTB test in a primarily outpatient population found a much lower PPV of 57% in patients with foot ulcers (clinically infected and uninfected).6 The prevalence of osteomyelitis in their cohort of infected foot ulcers was 20%. Unfortunately, confirmation of osteomyelitis was obtained only by bone culture and not histopathology. Despite the questions raised by this study, I continue to probe each and every wound, especially deep wounds, to ascertain whether a hard or gritty bone surface can be palpated with a sterile, blunt instrument (even the back of an applicator stick). I call this (as suggested by a colleague years ago) my “five cent bone scan”. When bone is palpated, I consider the patient to have clinical osteomyelitis or osteitis and will investigate further with cultures and imaging for confirmation. Although false positives can occur, I consider them to be fairly infrequent.
Several recent studies have confirmed the utility of the PTB test in diagnosing biopsy proven osteomyelitis, indicating a positive predictive value of 95 to 97% (often combined with plain radiography) in patients with clinically infected foot ulcers.8,9 Interestingly, the same authors who refuted the value of the PTB test in the outpatient ulcer population (above), in a subsequent study reported that the strongest independent risk for osteomyelitis was imparted by wounds that extended to (probed to) bone with a relative risk of 23.1.13 Therefore, it seems to me that the probe to bone test is a simple, efficient, and reliable test that can be done at bedside to indicate the likelihood of osteomyelitis underlying diabetic foot ulcers. In concert with appropriate imaging, the diagnosis can therefore be made sooner and facilitate earlier treatment – stay tuned for next month’s discussion on management of osteomyelitis!
As always, we encourage discussion and hope that you will feel free to let us know what you think. I also welcome your suggestions for future FootNotes.
References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on eTalk.
Best regards,
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
REFERENCES
Frykberg RG: An evidence-based approach to diabetic foot infections. American Journal of Surgery. 186 (Suppl 1):44-54, 2003
Frykberg RG, Wittmayer B, Zgonis T: Surgical Management of Diabetic Foot Infections and Osteomyelitis. Clinics Podiatr Med Surg. 24: 469-482, 2007
Thomas-Ramoutar C, Tierney E, Frykberg R : Osteomyelitis and Lower Extremity Amputations in the Diabetic Population. The Journal of Diabetic Foot Complications: 2010, 2 (1), No. 4, pp. 18-27.
Cierny III G, Mader JT,Penninck JJ: A clinical staging system for adult Osteomyelitis. Contemp Orthop 10:17–37, 1985
Wrobel JS, Connolly JE. Making the diagnosis of osteomyelitis. The role of prevalence.J Am Podiatr Med Assoc88(7):337-43, 1998
Lavery LA, Armstrong DG et al: Probe-to-Bone Test for Diagnosing Diabetic Foot Osteomyelitis. Diabetes Care 30:270–274, 2007
Grayson et al: Probing to bone in infected pedal ulcers. JAMA March 1995 273: 721-723
Lozano et al:Validating the Probe-to-Bone Test and Other Tests for Diagnosing Chronic Osteomyelitis in the Diabetic Foot. Diabetes Care 33:2140–2145, 2010
Aragon-Sanchez J et al: Diagnosing diabetic foot osteomyelitis: is thecombination of probe-to-bone test and plain radiography sufficient for high-risk inpatients? Diabet. Med. 28, 191–194 (2011)
Termaat MF, Raijmakers PG, Scholten HJ, Bakker FC, Patka P, Haarman HJ. The accuracy of diagnostic imaging for the assessment of chronic osteomyelitis: a systematic review and meta-analysis. J Bone Joint Surg Am87(11):2464-71, 2005.
Sella EJ, Grosser DM. Imaging modalities of the diabetic foot. Clin Podiatr Med Surg20(4):729-40, 2003
Lavery L, Peters E et al: Risk factors for developing osteomyelitis in patients with diabetic foot wounds. Diabetes Research Clinical Practice 8 3 ( 2 0 0 9 ) 3 4 7– 3 5 2
We need to take notice of the rest of the world in our management of diabetic foot disease. Diabetes UK shines with its work to promote the cause.
New NICE guideline on diabetic foot problems published
NICE has today (23 March) published a new guideline for the care of people with diabetic foot problems in hospital.
Diabetes is becoming one of the UK's biggest health problems. In 2009, it was estimated that there were 2.3 million people in the UK with type 1 or type 2 diabetes1. With rising numbers of people affected by the condition, the incidence of complications is also on the rise. These include foot problems such as ulcerations2and gangrene3, foot deformities, and infections which, if left untreated, can have a significant impact on a patient's quality of life. For example, by reducing a patient's mobility these problems can lead to loss of employment, depression, and damage to, or loss of, limbs. Each year in the UK, around 5,000 people with diabetes undergo leg, foot or toe amputations, equivalent to 100 a week4. Treating diabetic foot problems also has a considerable financial impact on the NHS through outpatient costs, increased bed occupancy, and longer hospital stays. Up to 20% (£600m) of the £3bn the NHS spends on diabetes each year goes on treating diabetic foot problems, and at least £252m of this is spent on amputation5.
There is currently some variation in practice in the management of patients with diabetic foot problems. This variation is due to a range of factors, including differences in the organisation of care between patients' admission to an acute care setting and discharge. This variability depends on geography, individual trusts, individual specialties (such as whether the service is managed by vascular surgery, general surgery, orthopaedics, diabetologists or general physicians) and the availability of podiatrists with expertise in diabetic foot disease.
The NICE guideline comprises a clear, authoritative source of information for NHS hospitals which will help overall management of diabetic foot problems, aiming to reduce variations in practice. It includes the following key recommendations:
Each hospital should have a care pathway for diabetic foot problems in diabetic patients who require hospital care.
A multidisciplinary foot care team should manage the care pathway
of patients with diabetic foot problems who require inpatient care. The multidisciplinary foot care team should normally include a diabetologist, a surgeon with the relevant expertise in managing diabetic foot problems, a diabetes nurse specialist, a podiatrist and a tissue viability nurse.
At the initial examination and assessment, the patients' feet should be examined for evidence of:
Refer patients with diabetic foot problems to the multidisciplinary foot care team within 24 hours of the initial examination of the patient's feet. Transfer the responsibility of care to a consultant member of the multidisciplinary foot care team if a diabetic foot problem is the dominant clinical factor for inpatient care.
When in hospital, patients with diabetic foot problems should have access to appropriate pressure reducing surfaces, to minimise the risk of pressure ulcer development on the affected limb.
Dr Fergus Macbeth, Centre for Clinical Practice Director at NICE, said: “Diabetes is one of the major health issues in the UK today, and each year more and more people are diagnosed with the condition. This increase in prevalence brings with it more diabetes-related complications such as foot problems, which are now the most common cause of non-traumatic limb amputation in the UK9. It's important, therefore, that the NHS is treating diabetic foot problems in the most clinically and cost effective way. This guideline provides clear, evidence-based recommendations for hospital staff treating patients (aged 18 years and above) who are admitted to hospital with diabetic foot problems or who develop them whilst in hospital. The guideline aims to reduce variations in the level of care that patients receive when they are in hospital, leading to fewer amputations, a better quality of life for those affected and lower NHS costs.”
Dr Gerry Rayman, Consultant Physician and Head of Service, The Diabetes and Endocrine Centre and Diabetes Foot Clinic and Research Unit,Ipswich Hospital NHS Trust said:“I was pleased to be involved in the development of this guideline because I have seen first-hand the very serious problems that can result from diabetic foot complications. This guideline will be a useful aid to all those involved in the treatment of such patients in NHS hospitals, and will, I'm sure, result in better care for patients.”
Kate Hill, patient/carer representative on the Guideline Development Group said: “Many people aren't aware that diabetes can also lead to foot problems, which can often be quite devastating. I'm confident that this new guideline will result in improved outcomes for patients with these problems.”
[6] Neuropathy is the loss of full sensation in the nerves and is caused as a result of the complications from diabetes. Diabetic neuropathy is directly related to the length of time that nerve fibres are exposed to hyperglycaemia.
[7] Ischaemia is a lack of adequate blood flow from the heart to the foot, and causes a reduction in the amount of oxygen and nutrients needed for the cells to continue to function.
[8] Charcot arthropathy is a progressive musculoskeletal condition characterised by joint dislocation, fractures and deformities. It results in progressive destruction of bone and soft tissue of weight-bearing joints, often in the foot and ankle.
[9] J. Boulton, L. Vileikyte, G. Ragnarson-Tennvall, and J. Apelqvist (2005). The global burden of diabetic foot disease.
Posted by: PV Mayer at 07:35 am 2 comments - Add a Comment Category: Diabetic Foot Ulcer Treatment
Maybe our own Ministry of Health should take notice?
Health Ministry to establish 20 diabetic foot clinics
By ARAB NEWS
Published: Mar 29, 2011 00:58 Updated: Mar 29, 2011 00:58
JEDDAH: The Ministry of Health (MOH) is opening foot clinics at each of the 20 diabetic centers it operates across Saudi Arabia.
"As the incidence of diabetes is increasing, the threat of diabetic complications is also growing. Diabetic foot ulcers are among the most common and serious complications of diabetes and if untreated can lead to amputation and severe lifestyle consequences for patients and their families," Dr. Khaled A. Abdulrahman Tayeb, consultant diabetologist and endocrinologist and director of diabetes and endocrinology center at Al-Nour Specialist Hospital, Makkah, said at the first MOH Diabetic Foot Academy which opened at Crowne Plaza Hotel on Monday.
According to the World Health Organization, the number of diabetes patients in Saudi Arabia is expected to grow by 283 percent by 2030 due to changes in lifestyle and diet leading to increasing levels of obesity. Heart disease and diabetes are two of the main causes of death in the Kingdom, which has the second highest rate of diabetes in the GCC after the United Arab Emirates.
Tayeb said that the Middle East and North Africa was one of the regions most affected by diabetes with a prevalence rate of 25 to 35 percent among the adult population.
Due to cultural, social, educational and climate factors, the incidence of lower limb lesions, including foot ulcers, among diabetic patients is very high — affecting about 50 percent of all diabetic patients. Twenty-five percent of Saudis are victims of diabetes.
Lack of appropriate foot-care and exposure of the foot — for example by wearing sandals — can contribute to the development of foot ulcers among diabetics and these can quickly lead to serious problems, including the need to amputate, said professor Gerit D. Mulder, director of the Wound Treatment and Research Center and professor of surgery of the trauma division at the University of California.
Mulder, who was the principal lecturer at the DFA, explained latest diabetes management techniques and shared solutions for the serious and growing problem of diabetic foot ulcer complications.
The three-day DFA, a new educational initiative by Smith & Nephew, focuses on the advanced management of lower limb lesions in diabetic patients being attended by physicians and surgeons from across the Kingdom.
It starts with glucose monitoring, but pressure, temperature and maybe even shear force tracking is just around the corner.
Posted: Apr 4th, 2011
Body sensors are joining the future internet
(Nanowerk News) Modern man is surrounded by a multitude of sensors. Today's sensors are simple and made for specific purposes, like measuring temperature, balance, build-up of smoke, or tyre pressure. The common trait of the sensors is that they are all embedded in a closed system.
Now researchers at the Department of Informatics, University of Oslo, are developing sensors for the future. Their size decreases. They are more robust than today's sensors, communicate wirelessly, and even reduce energy consumption to a minimum. But more important: The researchers are connecting all sensors to the Future Internet.
"We are developing a completely new paradigm within computer science, where we look at how to effectively exploit networked sensors. Computer programs can search for suitable sensors and employ them without up front knowledge about which sensors are actually available. The programs are also indifferent to which networks are present," explains Professor Thomas Plagemann at the Department of Informatics in University of Oslo in Norway.
He is head of the new SET (Smart Environment Technology) initiative. This is an interdisciplinary cooperation between as disparate disciplines as nanoelectronics, digital signal processing and distributed multimedia systems.
In order to meet the objectives the researchers must take into account a wide range of subjects, like wireless network technology and radio waves, ultra sound and infrared signals, signal processing, middleware, optimally collecting and aggregating data into databases, and security. They must also define formal concepts and new methods and standards.
By connecting the sensors to the Internet the computer can control the sensor information and find the optimal way of making use of the sensors.
"The new technology has immense possibilities. Examples include monitoring ocean currents, global warming, pollution, energy consumption, traffic, pollen dispersal, animal migration, and others. The future sensor network is also well suited for home care," says Thomas Plagemann to the research-magazine Apollon at University of Oslo.
Under Skin Sensors for Diabetes Monitoring
In cooperation with The Intervention Centre at Oslo University Hospital, Vestfold University College, and LifeCare in Bergen, the researchers are already working on the development of a brand new type of sensor that can be placed under the skin for measuring the blood glucose level.
"This nano instrument is only three times seven millimeters wide and consequently small enough to be injected underneath the skin. No operation is needed. A nano membrane moves when the blood sugar concentration is irregular," says Professor Tor Sverre Lande at the Department of Informatics.
He is an expert on sensors and networks and has previously developed an artificial ear, the reknown cochlear implant, that provides a sense of sound to deaf persons.
Philipp Häfliger (right) and Tor Sverre Lande have developed a small instrument that measures blood sugar concentration underneath the skin. When sensors are connected to the Internet, researchers can monitor all diabetes patients in Oslo simultaneously and investigate the relationship between insulin level and physical activity. The society can also use sensor networks for automating elderly care and monitoring nuclear disasters.
Wireless Energy
It is difficult to make body implant sensors that function over a long time span. All sensors need energy.
"A battery is too large. And we do not want to replace batteries within the body. Preferably batteries should be avoided. They can leak chemicals," Tor Sverre Lande explains.
The researchers have consequently developed wireless energy transfer between the glucose sensor and a bracelet carrying a battery.
Such wireless energy transfer is not more advanced than that of a standard high voltage current transformer. A magnetic field between two coils of wire causes voltage changes.
Exactly the same principle is applied to the diabetes patients.
"We have coils both underneath and outside the skin. Then the energy is transferred by electromagnetic waves."
During wireless energy transfer most of the energy is lost. Only two percent of the energy is caught by the skin-deep coil. The reason is that the antenna in the nano instrument is very small.
"It is therefore important to develop a glucose meter that uses as little energy as possible," explains Tor Sverre Lande.
Body Internet
The researchers also want to connect the glucose body implant to the Future Internet. By combining different technologies and measuring the level of insulin and how much the patients move, researchers can study the relationship between insulin level and physical activity.
It is easy to monitor patient movement using the built-in accelerometer of a modern mobile phone.
"By collecting data from all diabetes patients in Oslo we can obtain a detailed picture of how many diabetes patients are exercising. This can improve diabetes treatment. We also want the body sensor to talk with the mobile phone. Then the mobile phone can give a ring when the insulin level is too low, or say: "Take a walk"," envisions Plagemann.
Automated Elderly Care
Even elderly people and persons with dementia can benefit from networked sensors. The researchers at the Department of Informatics are investigating how sensors can be used in automated home care. The system among other things makes an alert if someone drops to the floor, or a dementia patient slips out of the apartment or forgets to turn off the stove.
"With such a system more elderly people can remain in their homes. This increases their well-being," Thomas Plagemann believes.
Different sensors can measure if a person lies on the floor. Some elderly will have camera surveillance. Others have an accelerometer in their mobile phone that measures if the patient moves.
"Our challenge is the large diversity of sensors. And the coverage area of the sensors is affected by the shape of the room."
Describes Diverging Behaviour
Plagemann's research group is currently making a high-level description of diverging behaviour.
"The computer program shall automatically detect sensors that offer the property "Person falls"."
The system must integrate many different technologies as it is not certain that all sensors in the apartment make correct observations. A camera sensor can trigger a false alarm if it registers a person having a sun bath outside the window.
If a motion sensor reports that a person has tumbled, it might happen that the person simply overdid some arm-swinging. And the demented person may not have run away. Maybe he is just visiting friends. The number of potential sources of error is large.
The system must therefore, completely automated, find all the sensors in the apartment, combine their information, and make a likely picture of what has happened.
The Future Internet is an important ingredience. In addition it is important with a swift interpretation of the data. It is of no use if the alarm goes off fifteen minutes after a heart failure.
Checking Nuclear Disasters
When sensors are connected to a network, they can also be used for supervising contaminated areas. Ground personnel had to move into the disaster area to make measurements of the radiation when the world woke up to the Chernobyl nuclear disaster in 1986.
At the next nuclear disaster sensors can be dropped from aircrafts to check radiation in the contaminated area.
"If the sensors can talk to each other, one can collect information from the radioactive area by connecting to the outermost sensor. Then one can avoid sending humans into the contaminated area," explains Tor Sverre Lande.
The main limitation of the sensors is the energy supply.
Sensors deployed in the nature need to function for a long time without the need for a battery change. Moreover it is important that the sensors can communicate and forward information even if the area does not offer network access. To transfer signals between two sensors the distance must not be too large.
The explanation is simple: The energy needed for sending signals over twice the distance, quadruples. That is: If it costs ten energy units to send a signal ten meters, then it costs 100 energy units to send the signal 20 meters. It is therefore better with many short distances between the sensors than one long distance.
If one wants a database in the sensor, it is important to be able to use it with as little energy consumption as possible. When the database is designed, it is therefore necessary with a detailed understanding of the sensor.
Computer scientists are structured persons. They are used to organizing everything in many layers, like placing hardware at the bottom. Then comes network and communication layers. And at the top they place databases and applications. Such a way of organizing matters requires internal communication between the layers. Consequently extra computation and energy are needed.
"To minimize the sensor energy used for communication between the database and the hardware, it has been necessary to diverge from this structure," explains Thomas Plagemann.
Data Carriage
Sensor networks can also be used to monitor global warming in polar areas or areas with a danger of landslides or avalanches.
Typically the mobile phone coverage is bad in such areas. The sensors can communicate and forward the information to chance passers-by that afterwards carry the information with them on their mobile phone. Then the information can be passed on when within a coverage area.
Weather Forecast using Cars
Modern cars are loaded with sensors. The researchers want to connect these sensors to the Future Internet.
An example of a sensor that is exciting for the society, is the rain sensor of modern cars.
In the future the rain sensors can communicate. Then the meteorologists can collect information from the sensors and update the weather chart. Instead of each car sending data to a shared weather database, it is more practical if the system collects information from a handful of cars while one's at it.
The railway administration can also make good use of a sensor network. They can use sensor networks to make alerts at landslides, by placing sensors with radars along the tracks. The system can also give notice if the rails need snow removal.
Intelligent Concrete
"Only the imagination sets a limit to what a sensor network can be used for," says Plagemann.
Sensors can also be placed in the concrete mix in new buildings. Then the sensors can inform if the buildings have been damaged after an earthquake.
Noise Map
By analyzing the background noise of all telephone calls it is possible to make a noise map of Oslo.
One can also use sensor networks to investigate possible relationships between the number of people and high humidity in a building.
Advanced Control Systems
Professor Oddvar Søråsen, head of the Nanoelectronics research group at the Department of Informatics in University of Oslo, is interested in how computers that interpret sensor data can control actuators.
In contrast to a sensor, that only observes, an actuator influences its surroundings. Actuators are small switches, valves, or robots that can perform simple tasks like regulating nerve signals or the fluid stream in a small chip. Actuators can also be used for intelligent air regulation, automatic control of livestock during the breeding season, or smart treatment of sewage and wastewater at heavy rainfalls and floodings.
To make new actuators the researchers want to combine micromechanics and microelectronics. This is a new field of research.
Today the micromechanics and the microelectronics are provided by two different chips. If we can produce both on one chip, we save communication between two chips. Then the power requirement is reduced.
When researchers design the nanopattern of a silicon chip, they can reserve parts of the chip for mechanical motion.
About sensor networks
In the networks of the future, sensors are connected to the Internet. This is called a sensor network.
The sensors will also communicate between themselves.
A sensor network offers immense possibilities and can among other things be used for elderly care, patient research, concrete monitoring, surveying contaminated areas, and traffic monitoring. Only the imagination sets the limit.
More evidence that smoking makes everything worse in those living with diabetes.
Nicotine Can Raise A1c by 34 Percent
Strong link between nicotine and diabetes complications....Scientists have reported the first strong evidence implicating nicotine as the main culprit responsible for persistently elevated blood sugar levels -- and the resulting increased risk of serious health complications -- in people who have diabetes and smoke.
The discovery also may have implications for people with diabetes who are using nicotine-replacement therapy for extended periods in an attempt to stop smoking.
Xiao-Chuan Liu, Ph.D., who presented the results stated that, "This is an important study and it is the first study to establish a strong link between nicotine and diabetes complications. If you're a smoker and have diabetes, you should be concerned and make every effort to quit smoking."
Doctors have known for years that smoking increases the risk of developing complications. Studies also show that smokers with diabetes have higher levels of HbA1c than nonsmokers with diabetes. However, nobody knew the exact substance in cigarette smoke responsible for the elevation in HbA1c. Liu and colleagues suspected it may be nicotine and set out to check nicotine's effects on HbA1c. Using human blood samples, they showed that concentrations of nicotine similar to those found in the blood of smokers did, indeed, raise levels of HbA1c.
"Nicotine caused levels of HbA1c to rise by as much as 34 percent," said Liu, who is with California State Polytechnic University in Pomona, Calif. "No one knew this before. The higher the nicotine levels, the more HbA1c is produced."
Doctors could use data from this study as a new basis for encouraging patients with diabetes to quit smoking, Liu said. What about nicotine patches, electronic cigarettes, and other stop-smoking products? Liu pointed out that people tend to use those products for only brief periods, and that the benefits of permanently stopping smoking may outweigh any risk from temporary elevations in HbA1c. However, the study may raise concern over the long term use of such products, he added.
Presented at the 241st National Meeting & Exposition of the American Chemical Society
New guidelines stress the crucial role that physical activity plays in the management of Type 2 diabetes: physicians should prescribe exercise....They replace recommendations made in the American College of Sports Medicine Position Stand, "Exercise and Type 2 Diabetes," issued in 2000.
Developed by a panel of 9 experts, the new guidelines are published concurrently in the December issue of Medicine & Science in Sports & Exercise and Diabetes Care.
"High-quality studies establishing the importance of exercise and fitness in diabetes were lacking until recently," the expert panel writes, "but it is now well established that participation in regular physical activity improves blood glucose control and can prevent or delay Type 2 diabetes mellitus, along with positively affecting lipids, blood pressure, cardiovascular events, mortality, and quality of life."
Most of the benefits of exercise are realized through acute and long-term improvements in insulin action, accomplished with both aerobic and resistance training, the experts write.
For people who already have Type 2 diabetes, the new guidelines recommend at least 150 minutes per week of moderate to vigorous aerobic exercise spread out at least 3 days during the week, with no more than 2 consecutive days between bouts of aerobic activity. These recommendations take into account the needs of those whose diabetes may limit vigorous exercise.
Sheri R. Colberg, PhD, writing chair, professor of exercise science at Old Dominion University, adjunct professor of internal medicine at Eastern Virginia Medical School, Norfolk, Virginia, and regular Diabetes In Control contributor, stated that, "Most people with Type 2 diabetes do not have sufficient aerobic capacity to undertake sustained vigorous activity for that weekly duration, and they may have orthopedic or other health limitations." "For this reason, the ADA [American Diabetes Association] and ACSM [American College of Sports Medicine] call for a regimen of moderate-to-vigorous activity and make no recommendation for a lesser amount of vigorous activity."
The panel specifically recommends that such moderate exercise correspond to approximately 40% to 60% of maximal aerobic capacity and states that for most people with Type 2 diabetes, brisk walking is a moderate-intensity exercise.
The expert panel also recommends that resistance training be part of the exercise regimen. This should be done at least twice a week -- ideally 3 times a week -- on nonconsecutive days. The panel also recommends that people just beginning to do weight training be supervised by a qualified exercise trainer "to ensure optimal benefits to blood glucose control, blood pressure, lipids, and cardiovascular risk and to minimize injury risk."
Regular use of a pedometer is also encouraged. In a meta-analysis of 8 randomized controlled trials and 18 observational studies, people who used pedometers increased their physical activity by 27% over baseline. Having a goal, such as taking 10,000 steps per day, was an important predictor of increased physical activity, according to the expert panel.
Finally, the new guidelines emphasize that exercise must be done regularly to have continued benefits and should include regular training of varying types.
Physicians should prescribe exercise, Dr. Colberg said in a statement. "Many physicians appear unwilling or cautious about prescribing exercise to individuals with Type 2 diabetes for a variety of reasons, such as excessive body weight or the presence of health-related complications. However, the majority of people with Type 2 diabetes can exercise safely, as long as certain precautions are taken. The presence of diabetes complications should not be used as an excuse to avoid participation in physical activity."
This work from Queensland University technology by way of the Voxy News Service. This is similar to works by our friends and colleagues Profs. Rayaz Malik and Andrew Boulton from Manchester, UK.
A simple eye test with a high powered microscope can be used to diagnose or monitor nerve damage resulting from diabetes - the most common cause of foot ulcers and amputations.
Using the corneal confocal microscope, researchers have now demonstrated that the shape and function of nerve fibres in the cornea can reflect the extent of diabetic neuropathy elsewhere in the body.
Professor Nathan Efron, School of Optometry, Queensland University of Technology (QUT), said diabetic neuropathy affects up to half of all people with diabetes and is currently assessed by a battery of sensory tests, nerve conduction measurements or tissue biopsies.
"The eye is a transparent structure and there is nowhere else in the body where you can look directly at nerves.
"We've found we can correlate visual evidence of nerve degeneration in the cornea with the severity of peripheral neuropathy," he added.
A recently published study of 100 patients with diabetes found corneal nerve fibre density, nerve fibre length and nerve branch density all decreased significantly with increasing neuropathic severity.
Speaking at the Asia Pacific Academy of Ophthalmology (APAO) Congress, Professor Efron said the test has also been used to monitor nerve regeneration in diabetic patients with severe disease following combined kidney and pancreatic transplants.
A $5 million longitudinal study currently underway at QUT and the University of Manchester in the UK will provide more data on how accurate the test is, how early diabetic neuropathy can be detected and the rate of nerve degeneration in diabetic neuropathy.
"While there is no cure or medication for diabetic neuropathy, early detection gives patients additional motivation to get their diabetes under better control and reduce the risk of complications such as diabetic foot ulcers," Professor Efron said.
"Ultimately we could also use this technique to test new therapies for neuropathy as they become available," he added.
Professor Efron said that while the technique is still largely a research tool, it has immediate clinical applications.
"I'm thinking it will be possible to add in this test, as a sensitive and specific early measure of diabetic neuropathy, to the regular eye checks for diabetic retinopathy," he added. "This will mean an expanded role for the ophthalmic professions in the detection of diabetic complications."
This release from the National Minority Quality Forum and the Congressional Black Caucus give what we at SALSA believe to be one of the highest quality hyperlink and data-rich informational releases in some time. Enjoy.
WASHINGTON, March 15, 2011 /PRNewswire-USNewswire/ -- The National Minority Quality Forum and the Congressional Black Caucus Foundation, in collaboration with the CBC Health Braintrust, is launching the U.S. Diabetes Index (USDI) (www.usdiabetesindex.com) – the national index by which diabetes in the United States will be measured. Other stakeholders include the Diabetes Care Project, and Gallup and Healthways, authors of the Gallup-Healthways Well-Being Index.
USDI and its companion website, www.usdireport.com, provide the most comprehensive source of available data about people living with diabetes, their care, and the trends that are shaping the disease in the United States. USDI houses more than 30,000 maps, charts and graphs depicting diabetes prevalence, costs, the uncontrolled and pre-diabetes populations, co-morbid conditions, and other important indices segmented by geography, including national, state, county, city, congressional, state legislative and zip code levels, and by age, gender, and race/ethnicity. USDI Report is an online web site designed to provide critical intelligence about the diabetes epidemic in the United States. Its mission is to reduce the incidence of the disease, improve patient outcomes while encouraging the effective management of our health care resources. USDI Report not only draws upon the robust amount of information to be found in the U.S. Diabetes Index, but also collaborates with Gallup and Healthways and other third party information providers to present the most current and updated depiction of diabetes in America.
Diabetes is a public health crisis in America with the elderly and minority populations most vulnerable to the ravages of this disease. According to the USDI, almost half of all patients with diabetes are not controlled; only 55 percent of diabetics check their blood sugar at least once a day; and more than half report not visiting their doctor over a 12-month period. The rising rates of obesity, the aging of the American population, the higher risk for the disease among minorities, and poor prevention are creating a health and economic crisis for the U.S.
Dr. Gary Puckrein, USDI developer and CEO of the National Minority Quality Forum, observed that, "Diabetes has geographical features to it; that is, blood glucose levels, prevalence, rates of hospitalization vary by geography. USDI allows us to direct our resources to the most affected areas so that those living with the disease in high-risk communities are no longer subjected to the patterns of avoidable hospitalizations and premature death that currently afflict them. We are pleased to make this resource available to our industry partners as well as to patient advocates and health partners such as the Diabetes Care Project (www.diabetescareproject.org) – a coalition of patient advocates and health partners committed to improving each patient's health outcome while lowering costs for the entire health system."
"We are pleased to collaborate with the National Minority Quality Forum," says Congresswoman Donna Christensen, MD, who chairs the Congressional Black Caucus Health Braintrust. "Given the health care and budgetary concerns that are in the forefront of deliberations on Capitol Hill and in state capitols across the country, this tool can help inform the public discourse on how and where health care dollars are best spent on diabetes prevention, care and treatment."
Dr. Jaime Davidson, Professor of Internal Medicine, University of Texas, Southwestern Medical School, Division of Endocrinology and a past Council member for the Texas Department of Health, noted that, "Mapping diabetes can help local physicians understand the populations they are working with and better tailor prevention and treatment efforts to that particular community. The maps crystallize the problem unlike any other resource available and graphically illustrate the diabetes crisis and the need for urgent action."
About the National Minority Quality Forum
The National Minority Quality Forum (www.nmqf.org) is a non-profit healthcare research and educational organization dedicated to the elimination of health disparities. The Forum supports national and local efforts to eliminate the disproportionate burden of premature death and preventable illness in racial and ethnic minorities and other special populations. The Forum has introduced user-friendly, web-based disease indexes to provide a unique two-dimensional view of various diseases, including diabetes, kidney disease, heart disease and HIV/AIDS, by ZIP code. Look for the National Minority Quality Forum on Facebook, and follow the Forum on Twitter (http://www.twitter.com/NMQF).
About the Congressional Black Caucus Health Braintrust
The Congressional Black Caucus Health Braintrust has long established itself as an authority on African American and minority health policy on Capitol Hill. The CBC Health Braintrust, under the able leadership of its Chair, Congresswoman Donna Christensen of the U.S. Virgin Islands, is on the front lines of ascertaining the minority health repercussions of all health policy proposals, as well as other social and public policy proposals, and supporting legislation that will ensure health equity and justice across all populations.
About the Diabetes Care Project
The Diabetes Care Project (DCP) (www.diabetescareproject.org) is a coalition of patient advocates and health partners whose goal is to educate patients, caregivers, healthcare providers and policymakers on the value of developing personalized management plans for diabetes patients in an effort to improve each patient's health outcome and lower costs for the entire health system. The DCP was founded by the National Minority Quality Forum and Roche Diabetes Care. Partners include the American Association of Diabetes Educators (AADE), the Alliance for Aging Research, and Healthways, Inc.
Diabetes appears to be nearing epidemic proportions. Because this particular disease produces a constellation of problems, there will be a tremendous strain on our health care system in the years to come. Of course, these financial expenditures are secondary to the suffering and disability that will result.
One of the most common problems associated with diabetes is an opening in the skin, which is called an ulcer. Because the skin is the body's best defense against the invasion of bacteria (which can easily lead to an infection), any opening in the skin is a cause for concern. Thisis especially true since diabetics have a reduced ability to fight bacteria. Even a tiny crack in the skin can lead to an infection; after all, germs are extremely small and don't need much space to get in.
Adding insult to injury, diabetes generally causes various nerve problems. This is not a reference to nervousness or any psychological problem but rather a dysfunction of certain nerves of the feet, thus causing decreased sensitivity. This condition is called neuropathy, and numbness is one of the more common consequences. Even worse, some experience an intense, burning pain that may continue unabated. Eventually, neuropathy will result in a gradual reduction in one's ability to detect trauma to the skin. Someone with neuropathy can walk around for days with a tack stuck in the foot and have no idea there is a problem. Even worse, they often will have no idea that an even greater problem, a deep infection, may be growing.
The piece de resistance is immune system problems, another of the many systems in the body affected by diabetes. With immunopathy, the sufferer has a reduced capacity to fight off invading bacteria. Thus, not only are they unable to feel a developing problem (which may initially be a very simple one), they are unable to fight off the germs that have invaded. This can lead to a limb-threatening infection.
Effective treatments for diabetics with nerve problems have been slow in coming. A certain class of pharmaceutical is often prescribed, although these have many side effects, and often relief is limited. But finally, there are better alternatives.
An unusual type of light therapy was developed roughly two decades ago, and there was much fanfare about its introduction, since it clearly helped with diabetic neuropathy. Unfortunately, the benefits were very temporary. A successful treatment for most people is one that provides lasting relief (certainly more than a few days to a week).
More recently, biochemists have synthesized a special form of a very important B vitamin that is a critical to nerve function. This chemical is lacking in diabetic neuropathy, so taking this vitamin consistently seems to be very helpful to those with diabetic neuropathy. It should be noted that the relief is not just symptomatic, but appears to be “curing” the nerves. Because of it's very recent introduction and significant cost, most physicians have little to no knowledge of it, as well as minimal experience with it.
Electrical stimulation is a term describing the use of electricity to speed healing and reduce pain in the human body. It is a very broad category, and there are many types, each with its own particular characteristics and uses. Research continues into different ways of using electricity in medicine to perform various functions. But a breakthrough occurred about 10 years ago in Italy when a device was developed that was found to have tremendously beneficial effects in reversing neuropathy and various other nerve problems. It is called Frequency Rhythmic Electrically Modulated Stimulation (FREMS), and has finally made its way to the U.S., where it is being tested by a select group of physicians.
Because of its capacity to reverse neuropathy for many months, it should become an important tool in the battle against the devastating effects of diabetes. This is even more true since it also has the ability to improve blood flow and as well as speed the healing of chronic wounds. FREMS appears poised to revolutionize the care of people with diabetes.
As use of this new technology spreads, further information concerning the use of the FREMS will come to light, so stay tuned.
Dr. Conway McLean is director of podiatry and surgery for The Medical and Foot Care Group in Palos Heights, Ill.
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
Classifying Diabetic Foot Ulcers
In the December 2010 FootNotes, we discussed the basics for managing diabetic foot ulcers (DFU). I’ve always believed that with a thorough, systematic approach to the examination of DFUs, one could appropriately institute treatment by addressing the basics — as well as those parameters found to be abnormal. For instance, if one does not look for ischemia in the neuropathic patient, the clinician can easily miss this important parameter that can impair wound healing. The neuropathic diabetic patient will often not have any symptoms of claudication or rest pain that we rely upon to trigger the suspicion for peripheral arterial disease (PAD). Similarly, infection can predict failure to heal. While active infection is fairly easy to diagnose, occult or smoldering underlying osteomyelitis often eludes diagnosis because there are often no commensurate laboratory or radiologic signs to herald its presence. Numerous studies have indicated that larger ulcers and those with a long duration are more likely to have concurrent underlying osteomyelitis. Therefore, I think that it is critical to make the diagnosis of these two common complicating factors when assessing DFUs on their initial presentation.
Classification – Why Do We Need It?
Although time and space preclude a detailed discussion, there are several well accepted classification systems for DFUs. The purpose of such classification is not only to communicate severity or status of a wound, but also to facilitate treatment. For instance, if one diagnoses bone involvement indicative of osteomyelitis then that diagnosis portends a certain level of risk for failure or even amputation. This, of course, relies upon looking for this complication in an otherwise non acutely infected foot ulcer. Furthermore, once the ulcer is classified as having bone infection, treatment must then follow. Along the same lines, once underlying PAD is diagnosed or suspected in a DFU patient, it is then incumbent upon the clinician to confirm the diagnosis and refer the patient for possible revascularization. Again, one must investigate carefully and look for this significant complication when assessing the patient presenting with a new or chronic foot ulcer. It really does not have to be complicated — with a thorough examination the appropriate treatment naturally follows. This is the value of classifying wounds. The classification systems require that the clinician evaluates these parameters in order to place the wound in various categories or grades. Progressively increasing grades of severity (or depth for instance) portend the need for more aggressive treatments as much as they portend risk for wound healing failure and amputation.
The Classification Systems - What is Most Helpful?
One of the older and perhaps more well known classifying schemes is that proposed by Wagner (and Meggit) in the 1970s. The Wagner system has six grades, from 0 to 5, representing the foot at risk for ulcer (0) to an entirely gangrenous foot (Grade 5). The extent of tissue loss or depth of penetration is well described, but the important concurrent parameters for infection and ischemia are missing from this scheme (not that I agree that gangrene should be classified as an ulcer). Nonetheless, partial foot gangrene (grade 4) requires at least a partial foot amputation and a Grade 3 lesion that penetrates to bone or joint will require further investigation and management for likely osteomyelitis (Figure 1).
Figure 1– click for larger view.
The shortcomings of this system lead to the development of theUniversity of Texas system in the mid 1990s. In this more thorough, but complicated system, infection and ischemia play important parts in the classification scheme that is really based on the Wagner system. Instead of six categories, or cells to remember, the UT System has 16 cells made of a grid (4 x4 table) consisting of 4 grades/depths and 4 stages (neuropathic (A), infected (B), ischemic (C), and (D) infected with ischemia). While this can become complicated to the unacquainted clinician, it has been validated as being predictive for amputation with increasing grades and stages (3D implying a wound penetrating to bone with both infection and ischemia). In addition to the UT System, the PEDIS system was developed in the last decade to be a more specific scheme to assist in the classification of DFUs for research purposes. Perfusion,Extent/size, Depth/tissue loss, Infection and Sensation are the components of interest in the PEDIS system. Again, the number of cells and complexity of the latter system make it difficult to use extemporaneously in clinical practice. On the other extreme, an overly simplistic approach such as mild, moderate, and severe is just too broad and nonspecific as to be of any great value.
Simplify When You Can
With all the aforementioned being recognized, I tend to simplify things as much as possible (it’s easier to remember and I do not need a wall chart to classify the wounds in front of me). All of the parameters already mentioned are incorporated into my evaluation and subsequent treatment plan. To me, however, classifying wounds as Neuropathic, Ischemic, or Neuroischemic facilitates treatment very nicely, especially with modifiers indicating infection and depth. In the most basic of terms, an infected 3 cm neuroischemic ulcer with exposed bone tells me all that I need to know in order to proceed with treatment. Furthermore, I know that there will be a high likelihood for osteomyelitis that will need to be treated once the patient has been referred out for revascularization. Granted, this is a simplistic approach, but one based on fully evaluating the parameters required for the more thorough classification systems. It works for me, although it may not be precise enough for interprofessional communication, validation, or for research purposes.
The point is to thoroughly and systematically assess DFUs and upon finding or suspecting important concurrent pathology, treat them appropriately. Let the examination facilitate or direct treatment. That is the true simplicity. As my friend Larry Harkless said years ago, “ You see what you look for, You recognize what you know”. In other words, look for problems and upon finding them, treat them. There is the simplicity (if foot ulcers can be considered simple) that we are all looking for.
I expect that my simplistic approach will generate a lot of consternation and criticism. This is a good thing and I welcome your comments. I have provided some key references below to assist in the support of this discussion and to clarify the various categorization systems mentioned.
As always, we encourage discussion and hope that you will feel free to let us know what you think. I also welcome your suggestions for future FootNotes.
References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on eTalk.
Best regards,
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound classification system. The contribution of depth, infection, and ischemia to risk of amputation. Diabetes Care. May 1998;21(5):855-859.
Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-Oct 2006;45(5 Suppl):S1-66
Abbas ZG, Lutale JK, Game FL, Jeffcoate WJ. Comparison of four systems of classification of diabetic foot ulcers in Tanzania. Diabet Med. Feb 2008;25(2):134-137
Wagner FW, Jr. The dysvascular foot: a system for diagnosis and treatment. Foot Ankle. Sep 1981;2(2):64-122.
Schaper NC. Diabetic foot ulcer classification system for research purposes: a progress report on criteria for including patients in research studies. Diabetes Metab Res Rev. May-Jun 2004;20 Suppl 1:S90-95.
Posted by: PV Mayer at 07:10 am 48 comments - Add a Comment Category: Diabetic Foot Ulcer Treatment
Single Podiatrist Visit: $3.5 Billion in US Health-Care Savings per Year
Results Now Published in Journal of the American Podiatric Medical Association
BETHESDA, MD--(Marketwire - March 16, 2011) - If every American at risk for developing a diabetic foot ulcer visited a podiatrist once before complications set in, the US health-care system could save $3.5 billion in one year. Closing this gap in podiatric care would reduce health-care waste on preventable conditions, which reportedly starts at $25 billion, by 14 percent.
This estimation is a projection based on findings from a Thomson Reuters study published in the March/April 2011 issue of the Journal of the American Podiatric Medical Association (JAPMA).
The study's numbers were based upon the American population that has either commercial insurance (116 million) or Medicare (46 million) in the Thomson Reuters MarketScan Research Database. Sponsored by APMA and independently conducted by Thomson Reuters, the study measured the health-care records of nearly 500,000 patients with commercial insurance and/or Medicare.
"The study's findings are astounding. If just one individual at risk for a foot ulcer sees a podiatrist once before a foot ulcer becomes apparent, they will have singlehandedly saved our country nearly $20,000 over three years," said Kathleen Stone, DPM, president of APMA. "This data does not even include the 47 million uninsured Americans or the 58 million currently on Medicaid, who have a higher incidence of diabetes and complications. The bottom line is that seeing a podiatrist saves limbs and lives, and equates to billions of needed dollars saved for America's health-care system."
After comparing health and risk factors for those who had seen a podiatrist for care to those who did not, the commercial insurance group saved $19,686 per patient over a three year time period. The Medicare group saved $4,271 per patient over the same three years. Conservatively projected, these per-patient numbers support an estimated $10.5 billion in savings over three years ($3.5 billion a year).
Including today's podiatrist in the diabetes management team is a vital step to preventing ulcers and amputation. Recent Centers for Disease Control and Prevention statistics show that in 2006, more than 65,000 lower limb amputations were performed in the US due to diabetes-related complications.
Diabetes currently affects nearly 26 million people in the US, seven million of whom are undiagnosed.
For additional information on the study and a link to the March/April JAPMA article, visitwww.apma.org/study-summary.
A terrific article by our colleague Prof. Werner Lang with a "perspective" by our equally perceptive SALSAmigo Rich Neville in this month's Vascular Specialist regarding Open vs. Endovascular Surgery. My SALSA partner, Joe Mills might say that, while endovascular procedures might be considered for many limb salvage procedures initially, it is the distal demand (i.e. the complexity of the wound) that is just as important as the type of lesion. Enjoy the article:
Elsevier Global Medical News (Mark S. Lesney)
NEW YORK – Endovascular therapy has increasingly become an
initial option for the treatment of critical lower limb ischemia, but
there are still indications for bypass surgery in some patients,
according to Dr. Werner Lang.
Despite data in favor of endovascular treatment, bypass
surgery still offers the best therapy with respect to long-term
patency. Even in patients for whom healing time may be short,
pedal vein grafts may still be the treatment of choice, said Dr.
Lang at the Veith symposium on vascular medicine sponsored by
the Cleveland Clinic.
Diabetic patients in particular may benefit from the bypass
surgery approach. There are no prospective randomized trials
with diabetic patients that have shown, with sufficient evidence,
an advantage in outcomes after endovascular therapy. However,
outcomes for subgroups in some studies suggest that
endovascular procedures are preferable in diabetic patients who
have multifocal tibial artery stenosis or occlusions.
In addition, there are trends indicating that limb salvage rates
are similar for endovascular therapy and bypass surgery. This is
possible because – even though its long-term patency rates are
lower – endovascular therapy is actually sufficient for many
patients: Their ischemic lesions will heal within the patency
period of the endovascular therapy, and thus long-term patency
is not needed in all cases.
Dr. Lang, professor of surgery at the Friedrich-Alexander
University Erlangen-Nuremberg (Germany) and chief of the
vascular surgery department at University Hospital Erlangen,
presented evidence showing that the selection of patients for
either endovascular therapy or bypass surgery should depend on
the ability to restore blood flow to the pedal arch with respect to
the angiosomes of the ischemic lesion. Endovascular therapy
must be considered inferior for any patients in whom this goal is
not attainable, which can be the case for diabetic patients in
particular.
"Another reason for a bypass-first strategy is the ability to
combine vascular surgery with plastic reconstructive surgery –
[for example,] free flaps with a microvascular anastomosis. For
diabetic patients, a microvascular anastomosis will not usually be
possible after endovascular therapy alone, as the quality of the
vessel wall of the original artery is generally poor in diabetic
patients even after such therapy," Dr. Lang said in an interview
Finally, the decision between a bypass-first strategy and an
angioplasty-first strategy should depend not only on angiographic
findings alone, but also on clinical characteristics and the need to
achieve direct revascularization of the pedal arteries, Dr. Lang
added.
PERSPECTIVE (by Richard F. Neville, Professor and Director of Vascular Services, George Washington University Hospital)
I agree with Dr. Lang regarding the role of endovascular therapy
and surgical bypass for lower extremity revascularization. I
believe we are now beyond the rush of enthusiasm for the
"endovascular first" approach for every patient and have moved
into the era of subgroup analysis to determine which patients are
best treated with which modality. Our own research, as
presented at this years Society for Vascular Surgery meeting in
Boston, identified at least one subgroup best treated with surgical
bypass – those patients presenting with tissue loss greater than
2 cms in largest diameter. Other important factors are arterial
anatomy, patient comorbidity, and the experience and skill of the
Work at TMI supports findings by the esteemed duo, Professors Andrew Boulton and David Armstrong.
Working to Save Lives and Limbs - New Hope Emerges For Canadians with Diabetic Foot Ulcers
In an article in this month's issue of Expert Opinion in Drug Delivery, (Informa UK Ltd) a group of US experts in the management of diabetic foot ulcers (DFU) has identified Collatamp G (Theramed Corp, Mississauga) as a promising and superior system for delivering high concentrations of broad-spectrum antibiotic directly to the ulcer for patients with Infected Diabetic Foot Ulcers. While Collatamp G is not yet available for use in the USA, it was approved by Health Canada in 2007, and since 2008 has been used increasingly in Canada for the treatment of serious Diabetic Ulcers.
Dr. P. Mayer, Medical Director of The Mayer Institute (www.themayerinstitute.ca) in Hamilton, Ontario which specializes in advanced diabetic foot and wound care, performed a trial of Collatamp G on 15 of his most serious cases. "We used Collatamp G on several chronic deep wounds associated with osteomyelitis with excellent result. By providing a direct assault on the infected bone, Collatamp G dramatically improved healing in chronic, non-healing wounds and in at least 3 instances Collatamp G was key in helping us prevent amputations".
From his research and experience, Dr. Mayer concurs with the study's conclusion and further states that "adoption of Collatamp G into the treatment protocol for advanced diabetic foot ulcers, could dramatically reduce the length of disability for these patients, and also reduce healthcare costs by reducing the need for daily home-care visits to once or twice weekly."
The Collatamp G product concept and technology is featured in an article co-authored by David G Armstrong and Andrew Boulton et al in this month's Expert Opinion on Drug Delivery (full reference: The use of gentamicin-impregnated foam in the management of diabetic foot infections: a promising delivery system?; Catherine D Griffis, Stuart Metcalfe, Frank L Bowling, Andrew JM Boulton, David G Armstrong, Expert Opinion on Drug Delivery, June 2009, Vol. 6, No. 6, Pages 639-642).
Improved and shortened time to healing in Diabetic Foot Ulcers can have significant implications to patients at risk of limb amputation, as well as to the healthcare system as a whole. Chronic Diabetic Foot Ulcers are a major cause of Home Care visits and Disability claims to health insurance providers. Accelerating the healing process can reduce the overall burden on the healthcare system by getting the patient back to work sooner. One of the major goals in management of Diabetic Foot Ulcer is 'Limb salvage', that is, the prevention of limb amputation, which is both costly and devastating to patients and their families.
Because diabetic foot ulcers are often complicated by infection, antibiotic therapy is an important component in the management of the wound. Unfortunately traditional systemic antibiotics do not result in sufficient concentrations at the target tissue due to a number of factors, including the poor micro and macro circulation present in people with diabetes, and the risk of toxicity associated with adequate doses. Because of these and other limitations of systemic antibiotics, the authors of the paper note that "topical [or local antimicrobial therapy in the management of infected foot ulcers has been supported by several authors" , whom they then cite. The authors also note that compared with other local delivery systems, Collatamp G has been shown in European studies to be the clinically and economically "superior delivery mechanism"
About Collatamp G:
Collatamp G (www.collatampg.ca) is a biodegradable and fully resorbable Gentamicin-Collagen Sponge. Upon application to a wound, the product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic (having a concentration-dependent mechanism of action), for local action. This achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold. Collatamp G was approved by Health Canada in 2007, and has since been used in hundreds of Canadian surgical procedures and Diabetic Foot treatments in over 40 Canadian Hospitals and Clinics.
About Infected Diabetic Foot Ulcers:
According to the Centers for Disease Control and Prevention (CDC), the estimated incidence of diabetes in the US exceeds 1.5 million new cases annually, with an overall prevalence of 20.8 million people, or 7% of the US population. By 2030, the International Diabetes Federation predicts that the Global prevalence of diabetes will almost double from 193 million people (estimated in 2003) to 366 million.
An estimated 15% of patients with diabetes will develop a lower extremity ulcer during the course of their disease. According to a large prospective study, approximately 7% of diabetic patients with foot ulcers will require an amputation. Diabetes is responsible for 75% of the non-traumatic lower limb amputations performed yearly in Canada. After a diabetic lower-limb ampuitation, 50% of patients will have their other limb amputated within 2 years. The mortality rate after limb amputation approaches 80% - a death rate second only to lung cancer (86%). The estimated cost of foot ulcer care in the US ranges from $4,595 per ulcer episode to more than $28,000, for the 2 years post diagnosis. The total annual cost of foot ulcer care in the US has been estimated to be as high as $5 billion.
Chronic ulcerations are often colonized or contaminated with bacterial pathogens that can prevent ulcers from healing. Many such wounds become clinically infected and require treatment with antibiotics. However, early diagnosis of diabetic foot infections is a clinical challenge as typical signs and symptoms of infection, such as pain, redness, or elevated circulating inflammatory markers, can be absent in individuals with neuropathic or neuroischaemic ulcers. Failure to diagnose and treat such infections can lead rapidly to the infection spreading, with the possibility of tissue necrosis, gangrene, osteomyelitis, and ultimately the prospect of a lower leg amputation.
Currently there are no antibiotics on the market specifically indicated for the prevention of diabetic foot infections. There is also reluctance by practitioners to use existing, systemically-acting antibiotics prophylactically because of concerns with systemic side effects and fear of propagating bacterial resistance with widespread use. Furthermore, diabetic ulcers are often associated with vascular disease and restricted peripheral blood flow, which may render systemically acting antibiotics less effective. By achieving very high localized concentrations of antibiotic, Collatamp G is designed to overcome these concerns.
March 11th, 2011
Posted by: PV Mayer at 12:59 pm 2 comments - Add a Comment Category: Diabetic Foot Ulcer Treatment
My father, who practiced medicine for over 66 years, told me that to be a great doctor you must be genuinely kind and have empathy for those in need. He was right!
Empathetic doctors get better results: Study
BY FRANK APPLEYARD, POSTMEDIA NEWSMARCH 9, 2011COMMENTS (1)
A doctor examines a patient in a file photo. In the study, researchers from Thomas Jefferson University in Philadelphia linked physicians' sympathy and compassion to the success of their treatment of patients with diabetes.
Photograph by: Justin Sullivan, Getty Images
OTTAWA — Doctors who are empathetic achieve better clinical results, a new study suggests.
In the study, researchers from Thomas Jefferson University in Philadelphia linked physicians' sympathy and compassion to the success of their treatment of patients with diabetes.
The study focused on 891 diabetic patients treated between 2006 and 2009 by 29 doctors at the school's department of family and community medicine. Prior to treatment, each of the physicians underwent a standardized test called the Jefferson Scale of Empathy, developed in 2001 to measure their empathy in the context of patient care.
"Our results show that physicians with high empathy scores had better clinical outcomes than other physicians with lower scores," Mohammadreza Hojat, a research professor at Jefferson Medical College, said in a release. The study is published in the March issue of Academic Medicine.
It found that diabetic patients in the care of physicians with higher empathy scores were better able to control their blood sugar and cholesterol levels than those with lower scores. Researchers said the results suggests that empathy in patient care contributes to higher patient satisfaction, trust and compliance, which leads to more desirable clinical outcomes.
"These findings, if confirmed by larger-scale research, suggest that empathy should be viewed as an integral component of a physician's competence," said Hojat.
"This study supports the recommendations of such professional organizations as the Association of American Medical Colleges and the American Board of Internal Medicine of the importance of assessing and enhancing empathetic skills in undergraduate and graduate medical education."
Dr. Jeffrey Turnbull, president of the Canadian Medical Association, said that while physicians have long known the importance of empathy in care, this study provides hard evidence.
"Doctors have recognized that, and patients have basically told us that in different ways. But now we have evidence to support this," he said. "It shows that amongst all that we can convey, one important component is sympathy and empathy."
The study comes on the heels of findings by University of Toronto and Duke University researchers in January that suggested that doctors fail to respond to emotional cues from their patients 90 per cent of the time.
Dr. Gary Rodin, an oncologist at the University Health Network in Toronto, said the success of diabetes treatment can be particularly affected by a doctor's empathy.
"Diabetes control involves a lot of attention to insulin dosage, exercise, diet and lifestyle. That involves collaboration between the patient and the physician, and the interaction has a big difference in outcome," he said.
"Empathy and communication are tied together, and those allow a more collaborative relationship with the patient. So it's not surprising that if you're trying to work with a patient on better diabetes control, and establish a more collaborative relationship you'll be working together towards the same goal."
Turnbull admitted that while empathy is increasingly important in medicine, attempting to teach doctors to be empathetic is a challenge.
"I don't think you can teach empathy in the traditional ways — that's something you can only do through role-modelling and having patients help us as teachers," he said.
"Patients are very good at saying things like 'This is valuable to me,' and 'I felt better about things when you said it that way.'"
Robert Wender, one of the co-authors of the study, also pointed to the significance of the findings.
"Although physicians intuitively value empathy, the clinical importance of empathy has not been known. We're now on our way to showing the power of physician empathy to impact the health of our patients," he said in a statement.
Negative Pressure wound therapy (NPWT) using the KCI Vacuum Assisted Closure (VAC) device is a well recognized modality to assist in the healing of complex wounds. The case presented in this article demonstrates its use in a complicated patient with osteomyelitis of the 2nd MTP joint who refused definitive cure by partial ray amputation.
The patient was a 51 y/o female, 231 lbs with insulin dependent diabetes mellitus and a long history of smoking and non-adherence with medical advice. She was admitted with the diagnosis of septic arthritis of the 2nd MTP joint with contiguous osteomyelitis of the base of the proximal phalanx of the 2nd toe and the head of the 2nd metatarsal. She had cellulitis of the forefoot with an open draining ulceration in the 1st interspace that probed to the joint.
On the day of admission she was taken to the operating room and an incision and drainage was performed. The patient unequivocally refused partial ray amputation stating "If I wake up and my toe is missing I am going to sue the a** off the surgeon!" At the time of surgery minimal purulence was found. Bone around the joint was noted to be mildly necrotic. It was debrided and a sample was sent to pathology and microbiology. Vancomycin impregnated calcium sulfate beads were implanted.
One day after the procedure a KCI VAC was placed onto the open surgical wound and over the implanted beads.
Cultures from bone and soft tissue grew a community associated MRSA (CA-MRSA) with a vancomycin MIC =1 and sensitive to both tetracycline and trimethoprim/sulfamethoxazole. Pathologic examination of the bone was read as being "consistent with osteomyelitis". The patient continued to refuse partial ray amputation or, for that matter, even amputation of the toe. The VAC was continued as the wound was granulating well. The podiatric surgeon decided to return the patient to the OR for placement of an external fixator to maintain the alignment and length of the segment.
The patient was discharged from the hospital on oral doxycycline for 3 months. At 6 months the patient had totally healed the surgical site.
Although chronic bone changes were seen on x-ray they did not appear to be suggestive of an active osteomyelitis.
At just over 1.5 years the patient has not had any evidence of infection and is clinically stable.
Although this case is not unique it does present some interesting clinical decision points:
The IDSA infection severity scale has become a standard used in most clinical trials and is being used in the clinical scenario to “get everybody on the same page” when it comes to the extent of infection and approach to treatment. In this case, the patient was graded as having an IDSA Moderate infection
How is osteomyelitis diagnosed? Although MRI may be the imaging standard, in this case plain film x-rays, pathologic examination of bone and, the true “gold standard”, positive bone culture were used without the need for more advanced imaging.
The patient refused “definitive” or ablative surgical treatment of her osteomyelitis. Recent evidence supports the use of more conservative surgery plus oral antibiotics as effective, as it was in this case.
After the initial I&D the patient needed dead space management. Certainly, the implantation of antibiotic beads may be useful, but to really get this wound to begin to close NPWT with the VAC was an important adjunct as it is in many of our diabetic foot infection patients following I&D and aggressive debridement.
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Posted by: PV Mayer at 06:39 am 2 comments - Add a Comment Category: Negative Pressure Wound Therapy
Yvan Charron has the dressings on his legs changed two or three times a week by home-care nurse Mary Hicks.
Photograph by: Wayne Cuddington, Ottawa Citizen
OTTAWA — Three years ago, when Yvan Charron’s legs began retaining fluid and swelling, just leaving his apartment became a struggle. Then, ulcers started appearing on his calves and feet, the result of poor circulation and nerve damage from diabetes.
By the time he showed up at a hospital emergency room, an infection had festered, turning the tissue surrounding one of his toes black. The toe had to be amputated.
Following surgery, Charron started receiving home nursing visits. Three times a week, nurses cleaned and bandaged his lower limbs, ensuring that relatively minor cuts and sores were treated before they became serious.
Last summer, Charron was enrolled in a test program aimed at overhauling Eastern Ontario’s wound-care services. The program was also designed to provide him with better medical observation and followup, which could reduce the risk of another amputation.
“The nurses tell me, ‘If you’re a diabetic, don’t treat (the ulcers) as nothing,’” Charron says. “That’s how I lost my toe.”
Patients such as Charron, 57, are major consumers of health care. In Ontario, the annual bill for treating venous leg ulcers and diabetic foot ulcers is $511 million, according to a 2007 study in the journal Wound Care Canada.
At the Champlain Community Care Access Centre (CCAC), which connects Eastern Ontarians to home and community health services, more than 40 per cent of the 3,600 clients who receive nursing services require care for ulcers, surgical wounds or trauma injuries. That translates to more than 1,400 clients a year.
With budget pressures and an exploding diabetes epidemic, health officials are realizing that targeting the neediest patients, such as Charron, will lead to better care at a lower price, especially if services are co-ordinated, red tape is eliminated and supplies are purchased up front to speed healing.
The journal study pegged the possibility for savings at $338 million annually, or a whopping two-thirds of current spending. A more conservative savings estimate of $50 million a year has been offered by the Ontario Association of Community Care Access Centres, the Ontario Hospital Association and the Ontario Federation of Community Mental Health and Addictions Programs.
Beyond the potential for curbing costs, the overhaul is being driven by a recognition that patients with wounds tend to receive poor care. Some go to clinics to have their wounds treated, but there often isn’t any followup.
In particular, diabetics, who are vulnerable to foot wounds that can lead to amputation, lack access to preventive foot care because visits to chiropodists are not covered by public health insurance. Because of the disease, many diabetics have lost so much sensation in their feet that there is no pain to alert them to potential danger, meaning they often continue walking on sore, infected legs. When complications arise, they cycle in and out of hospital, which is expensive and ineffective, experts say.
Brian Golden, a University of Toronto management professor who helped design the overhaul, says the traditional way of providing community-based wound care has not served patients or taxpayers well. The CCAC farms out such care randomly to multiple home-care agencies and professionals. The lack of co-ordination can lead to unnecessary red tape and service delays, he said. In addition, many nurses are not specialists in diabetic foot care, meaning the best treatments are not always followed. For example, using a certain sandal, even if it’s more expensive, can take the pressure off wounds, speed healing and reduce the number of nursing visits needs, saving a lot of money in the end. Yet many care providers aren’t aware of it.
Under the overhauled program, the Champlain CCAC has started deploying teams of case managers who specialize in wound care to organize services around patients. It has also assigned a single provider, Carefor Health and Community Services, to be responsible for all aspects of a patient’s care, from treating the wound to addressing any underlying causes.
In the case of diabetics, that could mean sending a dietitian to the home as well as a nurse who specializes in wound care. Through his CCAC case manager, Charron was connected to a family doctor and foot-care clinic.
Since the program was launched last June, the Champlain CCAC has seen a substantial drop in the time it takes patients’ wounds to heal, says Claire Ludwig, manager of client services. The goal is to reduce avoidable hospital visits by wound-care patients by 10 per cent, Ludwig says.
Stem Cells Show Potential to Aid Diabetic Wound Healing
Transplanting human umbilical cord blood-derived endothelial progenitor cells (EPCs) has been found to "significantly accelerate" wound closure in diabetic mouse models....Dr. Wonhee Suh of the CHA University Stem Cell Institute, the study's corresponding author stated that, diabetes is often associated with impaired wound healing. While the therapeutic potential of transplanted EPCs has been demonstrated in animal models and in humans who have suffered stroke, myocardial infarction and peripheral artery disease, their effect in healing stubborn wounds has not been studied to the same degree.
"EPCs are involved in revascularization of injured tissue and tissue repair," said Dr. Suh. "Wounds associated with diabetes that resist healing are also associated with decreased peripheral blood flow and often resist current therapies. Normal wounds, without underlying pathological defects heal readily, but the healing deficiency of diabetic wounds can be attributed to a number of factors, including decreased production of growth factors and reduced revascularization.
The researchers, who transplanted EPCs into an experimental group of mice modeled with diabetes-associated wounds, but did not transplant EPCs into a control group, found that the EPCs "prompted wound healing and increased neovascularization" in the experimental group.
"The transplantation of EPCs derived from human umbilical blood cells accelerated wound closure in diabetic mice from the earliest point," said Dr. Suh. "Enhanced re-epithelialization made a great contribution in accelerating wound closure rate."
The researchers found that growth factors and cytokines (small proteins secreted by specific cells of the immune system) were "massively produced" at the wounded skin sites and contributed to the healing process.
"It remains unclear, however, which mechanism plays the dominant role in EPC-mediated tissue regeneration," commented Dr. Suh. "Further study is required since numerous studies have shown that the actual magnitude of EPC incorporation into the vasculature varies substantially.
"This experimental study opens the possibility of the future clinical use of endothelial progenitor cells derived from human cord blood in the treatment of diabetic wounds in humans. It also shows that the culture medium used to grow the cells (conditioned media) has the same healing effect as the cells, so that it could be used as a cell-free form of treatment."
Millions of people with Type 2 diabetes in both poor and rich countries remain undiagnosed or do not receive effective treatment to control their disease.
A new study that was carried out in seven developed and developing countries showed that poor diagnosis and ineffective treatment of diabetes have laid millions of people worldwide at risk of disabilities and early death from diabetes and its related illnesses such as heart disease, blindness, chronic kidney disease and diabetic foot that might require amputations. The new research, the results of which were published in theBulletin of the World Health Organization, examined diabetes diagnosis, treatment, and management in Colombia, England, Iran, Mexico, Scotland, Thailand, and the US. Among the studied countries, Mexico showed the highest prevalence of diabetes, with 24 percent of men and 21 percent of women over the age of 35, while England and Scotland had the lowest prevalence. However, the findings indicated that there was no association between a country's relative wealth and the standard of diagnosis or treatment it provides for diabetic patients, wrote scientists from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. “Too many people are not being properly diagnosed with diabetes and related cardiovascular risk factors. Those who are diagnosed aren't being effectively treated,” said study author Dr. Stephen Lim. “This is a huge missed opportunity to lower the burden of disease in both rich and poor countries.” The findings showed that in the US, nearly 90 percent of adult diabetics, or more than 16 million adults aged 35 and older, fail to meet widely accepted targets for healthy levels of blood sugar, blood pressure and cholesterol while the rate of those failing to meet the targets includes 99 percent of adult diabetics. In Thailand, up to 62 percent or more than 663,000 men surveyed were either undiagnosed or untreated for diabetes. Personal wealth and education were not a significant factor in the rate of diagnosis and treatment in any of the countries except in Thailand while enjoying health insurance had a notable influence. “In countries where we had information on health insurance, it actually played a significant role in getting diagnosed and effectively treated for diabetes,” said Dr. Emmanuela Gakidou. According to the World Health Organization (WHO) estimate, about 280 million people, or 6.4 percent of the world's population, are suffering from Type 2 diabetes. “The cost of leaving individuals with diabetes untreated in the future will be huge, and a lot of the costs could be averted by better management of the health risks of these individuals,” warned Gakidou.
Vinegar, when taken regularly, can help manage diabetes, moderate food cravings and increase the body's absorption of calcium resulting to healthier bones....
The study by the Arizona State University researchers concluded that, "The antiglycemic properties of vinegar are evident when small amounts of vinegar are ingested with meals composed of complex carbohydrates."
The study claims that postprandial glycemia is reduced by vinegar, a view endorsed by the American Diabetes Association, which said that the reduction of PPG is crucial in the management of diabetes.
Investigators in the department of nutrition at Arizona State University tested a simple vinegar drink -- 20 g of apple cider vinegar, 49 g of water, and 1 teaspoon of saccharine -- on 10 healthy, nondiabetic volunteers.For comparison purposes, on different days, subjects were assessed after consuming a placebo drink consisting of 60 g of water and 1 teaspoon of saccharine or a calcium acetate drink. On each occasion, the drink was consumed after subjects had eaten a breakfast of bagel and orange juice on an empty stomach. Blood samples were drawn at 0, 30, 60, 90, and 120 minutes after the meal.
Carol S. Johnson, RD, and colleagues report that after subjects consumed the vinegar drink, their 60-minute glucose excursions were 35% lower than after placebo. On average, energy consumption was reduced by >300 calories for the rest of the day, according to the group. No difference was noted following the calcium acetate drink.
Before this, a Swedish study published in the September 2005 issue of the European Journal of Clinical Nutrition stated that consumption of vinegar with white bread "cut expected rises in insulin and blood sugar" and made the subjects feel fuller.
In 2006, university scientists in Ebetsu, Japan, found that vinegar increases the extraction of calcium from food. They claimed that a diet containing 1.6 percent vinegar for 32 days increased calcium absorption.
To get the full health benefits of vinegar, consumers should stick to natural kinds of vinegars, including Supremo Cane Vinegar. Made from 100 percent naturally fermented ingredients, it is one of the few all-natural vinegars available locally. Other natural sources for vinegar include coconuts, nipa palm and apples.
It is always safer to choose all-natural vinegars made from pure cane. While vinegar has numerous benefits, those that contain unnatural ingredients can be very damaging to healthy athletes.
Sanofi-aventis and Sunnybrook Health Sciences Centre announced that they have entered into a research agreement and licensing option for vasculotide, an investigational compound to treat chronic wounds. This includes neuropathic diabetic foot ulcers caused by a lack of sensation and neuropathic ulcers that are complicated by peripheral arterial disease, commonly called neuroischemic diabetic foot ulcers.
“Our new relationship with Sunnybrook Health Sciences Centre fits our strategy of fostering scientific exchange through external collaborations and will help us develop solutions for patients suffering from diabetic foot ulcers,” said Ray Jupp, Vice President of sanofi-aventis’ Therapeutic Strategy Unit, Fibrosis and Wound Repair.
The Fibrosis and Wound Repair unit is one of five Therapeutic Strategy Units created as part of sanofi-aventis’ new R&D model. Three of these units cover major pathophysiology areas where there is significant unmet medical need: immuno-inflammatory disorders, infectious disease and fibrosis and wound repair. The remaining two incorporate work in a challenging area of public health (the physiology of aging) and a high-potential geographic segment (Asia-Pacific region). The focus of the Therapeutic Strategy Units is to identify health solutions through pooling internal and external expertise and bring them to the clinic.
“Sunnybrook is dedicated to making discoveries and delivering them to patients—it’s at the heart of all that we do,” said Dr. Michael Julius, Vice President of Research at Sunnybrook. “Vasculotide, invented by senior scientist Dr. Dan Dumont and Dr. Paul Van Slyke at Sunnybrook Research Institute, is one of our most exciting discoveries. We are grateful that our commercialization agent MaRS Innovation identified sanofi-aventis as the ultimate partner, and we are committed to working with sanofi-aventis to help us develop vasculotide further.”
Vasculotide is a synthetic peptide-based growth factor that targets Tie2, a receptor on specialized cells of the hematopoietic and vascular systems. Close to two decades ago, Dr. Dumont and his colleagues were the first to discover and detail the importance of Tie-2 and its role in the formation of blood vessels. Dumont and Van Slyke are now investigating the use of vasculotide for restoring vascular health and accelerating healing during wound repair. Vasculotide may provide a shortcut to the series of molecular activities involved in blood vessel growth that ultimately lead to wound closure, which may improve healing in patients.
Under the terms of the agreement, sanofi-aventis has an exclusive worldwide option with predetermined upfront milestones and royalty payments with Sunnybrook to develop and commercialize vasculotide. The agreement was signed through Sunnybrook with the assistance of its commercialization agent MaRS Innovation. Financial terms of this agreement were not disclosed.
About Angiogenic Compounds
Angiogenesis is a physiological process involving the growth of new blood vessels from pre-existing vessels and is an essential process to wound healing and combating diseases characterized by either poor vascularization or abnormal vasculature. Several diseases, such as ischemic chronic wounds, are the result of failure or insufficient blood vessel formation and may be treated by angiogenic compounds that foster local expansion and/or stabilization of blood vessels, thus bringing new nutrients to the site and facilitating repair.
About Neuropathic and Neuroischemic Diabetic Foot Ulcers
Foot ulcers are a frequent cause of morbidity and mortality in patients with diabetes mellitus. Neuropathic diabetic foot ulcers are a type of diabetic foot ulcer associated with diabetic peripheral sensorimotor neuropathy. The lack of sensation in the foot in combination with other factors, such as foot deformities and unperceived trauma (e.g., inappropriate footwear) leads to skin breakdown. Neuroischemic diabetic foot ulcers are ulcers occurring in patients with diabetic neuropathy and decreased blood flow to the foot due to peripheral arterial disease, commonly seen in diabetic patients. Neuroischemic ulcers are associated with significant morbidity and mortality as well as high costs of medical care (related to hospital costs, revascularization and wound-related procedures, and management of infection). If untreated over time or infected beyond repair, neuroischemic foot ulcers may damage one’s foot to such an extent that amputation is unavoidable.
Posted by: PV Mayer at 09:39 am 0 comments - Add a Comment Category: Diabetic Foot Ulcer Treatment
Easy, quick and informative diabetic foot exam from our CAWC
60 Second Diabetic Foot Screen
The 60 Second Diabetic Foot Screen Tool is designed to assist in screening persons with diabetes to prevent or treat diabetes-related foot ulcers and/or limb-threatening complications. Please click here to access the tool.
Understanding the Etiology of the Diabetic Charcot Foot
In FootNotes Issue 12, we discussed a very important and potentially limb-threatening complication of diabetes - the Charcot Foot. Having just returned from an International Consensus Conference in Paris dealing with this entity, and having visited the Charcot Library at La Salpetriere, I feel compelled to discuss its etiology and diagnosis in a little more depth than most readers might be familiar with. While we focused on appropriate treatments last time, it is equally important to fully understand the underlying pathophysiology - the process behind the deformity.
This rare complication of diabetes ultimately has peripheral neuropathy as it’s primary predisposing risk factor. In fact, neuropathy must be considered the sine qua non for the development of this very destructive bone and joint disorder. While Charcot first described his findings of the “arthropathies of locomotor ataxia” in patients with tabes dorsalis (syphilis), we now recognize diabetes to be the most common disease with which this entity is associated. More specifically, it is associated with patients who have long standing diabetic peripheral neuropathy. Despite this, we know that peripheral neuropathy resulting from any disease can potentially predispose that extremity to the development of a “Charcot joint”. Aside from diabetes and tabes dorsalis, leprosy and alcoholism are two of the more common diseases having been associated with Charcot arthropathy of the lower extremities. In the upper extremity, syringomyelia might be the most notable potential disease associated with the condition. Nonetheless, neuropathy alone does not cause Charcot arthropathy. Trauma, either a minor occult injury, prior foot surgery, or a significant traumatic event such as an ankle fracture, is usually the precipitating event leading to the gradual breakdown of the architecture of the foot. Unfortunately, due to the insensitivity present, a definite history of trauma (especially minor injury) cannot be determined in most cases. The diminished sensation of pain (or total insensitivity) allows the patient to continue walking on the injured foot, thus promoting further injury. In essence, a “vicious cycle” of initial injury followed by repetitive injury and further deterioration is created. As might be expected, this results in swelling, erythema, deformity, and acute inflammation in the initial stages of this arthropathy. In fact, it is the acute inflammation without commensurate degrees of pain that most often characterize the initial presentation of such patients. Classically considered painless, most current reports indicate that pain is usually present in the acute stage, but much less than would be expected for the degree of injury noted on radiographs.
"...it is the acute inflammation without commensurate degrees of pain that most often characterize the initial presentation of such patients."
The foregoing is the simplified version of the pathogenesis of the Charcot foot, but there are several theories regarding the etiology of the condition. In addition to the neurotraumatic theory described above, the neurovascular theory has at its core a primary role for autonomic neuropathy and commensurate osteopenia or osteoporosis. The weakened bone would naturally be more susceptible to fracture, dislocation, and osteolysis even from normal degrees of stress. More likely, it is a combination of these two manifestations of neuropathy that predispose to the acute development of Charcot arthropathy after even the subtle trauma of a minor ankle sprain (see table 1).
In the last decade or so, much has been learned about bone physiology and the signaling systems leading to bone resorption and deposition. Although an in-depth discussion is beyond the scope of this article, the reader must become familiar with the RANKL/ OPG counterbalancing system that regulates osteoclastogenesis in normal and abnormal states of bone physiology. In states characterized by excessive bone lysis or even osteoporosis, an over expression of RANKL leads to an increase in the maturation and proliferation of osteoclasts. Osteoprotegerin (OPG), acting as a decoy receptor for the RANKL, normally will bind with excessive RANKL to mitigate its effects on osteoclastogenesis. Hence, there is normally a fine regulation on bone destruction and production. It is believed that those patients developing Charcot changes characterized by excessive bone lysis and osteopenia, there is a dysregulation of the RANKL/OPG ratio (with an excess production of RANKL above and beyond that which can be balanced by OPG). Recent evidence indicates that there is likely a genetic variation in these patients compared to those who heal their fractures and injuries normally. Perhaps this can explain why the Charcot foot occurs in less than one percent of the entire diabetes population and in only about one-third of those with neuropathy. Not all neuropathic patients go on to develop Charcot foot deformities after a fracture or minor injury. Most go on to heal uneventfully. However, it is that, as of yet, ill defined subgroup of diabetic neuropathic patients who might go on to develop Charcot arthropathy that gives us pause whenever we are faced with patients as described above. Since we have no diagnostic markers nor definitive lab tests as of yet to determine susceptible patients, we must treat all injured neuropathic patients with great caution and a high index of suspicion for Charcot arthropathy.
"Charcot foot occurs in less than one percent of the entire diabetes population and in only about one-third of those with neuropathy."
The diagnosis of the acute Charcot foot is therefore a critical one and one that needs to be made at the initial patient presentation if we are to prevent the gross deformities typical of the chronic Charcot foot. This will be the subject of our next FootNotes e-zine. In the meantime, I have listed some general references below that will provide you with more detail on the natural history and pathophysiology of the Diabetic Charcot Foot.
References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on eTalk.
Best regards,
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
REFERENCES
Frykberg RG (Editor): The Diabetic Charcot Foot: Principles and Management. Data Trace Publishing Company. Brooklandsville, MD. 2010
Wukich DK, Sung W. Charcot arthropathy of the foot and ankle: modern concepts and management review. J Diabetes Complications. Oct 16 2008.
Jeffcoate W. The causes of the Charcot syndrome. Clin Podiatr Med Surg. Jan 2008;25(1):29-42, vi.
Wukich DK, Sung W, Wipf SA, Armstrong DG. The consequences of complacency: managing the effects of unrecognized Charcot feet. Diabet Med. Feb 2011;28(2):195-198.
Pitocco D, Zelano G, Gioffre G, et al. Association between osteoprotegerin G1181C and T245G polymorphisms and diabetic charcot neuroarthropathy: a case-control study. Diabetes Care. Sep 2009;32(9):1694-1697.
Frykberg, RG, Rogers, LC: The Diabetic Charcot Foot: A Primer on Conservative and Surgical Management. The Journal of Diabetic Foot Complications, 2009. Volume 1, Issue 1, No. 4
More than 44 million Americans will have diabetes within 25 years under current trends, and the annual cost of caring for them will triple to $336 billion in constant 2007 dollars....Elbert S. Huang, MD, MPH, of the University of Chicago, and colleagues reported that, the obesity epidemic, ever-earlier ages of diabetes onset and increasing longevity of people with established diabetes are combining to enlarge the diabetic population far beyond anything envisioned in earlier projections.
"Without significant changes in public or private strategies, this population and cost growth are expected to add a significant strain to an overburdened healthcare system," the researchers warned.
Currently, some 24 million Americans are living with diabetes, Huang said in a briefing for reporters. "Already this represents a great economic burden for the country and for government programs like Medicare," he said. Huang and colleagues estimated that costs to Medicare would rise nearly fourfold, from about $45 billion currently to $171 billion in 2034, in constant dollars.
Previous forecasts had projected slower growth in the number of diabetic patients. For example, a 2001 study by CDC researchers estimated that about 29 million Americans would be diagnosed with the disease in 2050.
Unlike earlier efforts, Huang and colleagues included trends related to obesity in their model for projecting future cases of diabetes, as well as data from the 2004 United Kingdom Prospective Diabetes Study (UKPDS) on the natural history of the disease.
The UKPDS data allowed the researchers to develop a model by which individuals with certain disease durations and ages were expected to have developed corresponding levels of cardiovascular, renal, ocular, and other complications.
"We know that the average cost of treating diabetes in newly diagnosed people is substantially different from the costs of treating someone who has lived with diabetes for 20 or 30 or 40 years and is suffering from microvascular or cardiovascular complications," Huang explained.
Data from the U.S. government's Medical Expenditure Panel Survey were used to attach treatment costs to care of diabetes and the associated complications at different patient ages and disease durations.
"Our model accounts for that natural history and the change in the life of a patient," he said. That is why the study forecast more rapid increases in costs than in the diabetic population -- because patients are living longer with these expensive complications.
The study also took account of trends in body mass index distribution. According to the group's projections, "overall obesity distribution in the nondiabetes population remains fairly stable over time, with about 65% of the population being overweight or obese."
Some 35% of the population will be overweight throughout the period, while the percentage classed as obese will decline from 30% currently to 27% by 2034, the researchers said.
The obesity projections were based on UKPDS and U.S. data on how body mass index changes with age. Actual obesity prevalences could be higher or lower if eating and exercise habits or anti-obesity medical treatments change significantly.
The current study did not analyze the potential effects of interventions aimed at reducing the incidence and severity of diabetes. But Huang said small-scale programs promoting healthy eating and exercise have shown the ability to affect the natural history of diabetes.
Matt Petersen, a spokesman for the American Diabetes Association, said "Realistic and achievable amounts of changes in diet and physical activity do have a clinically significant effect on primary prevention."
But Huang acknowledged that, outside of formal clinical studies, "it's not clear that... community efforts are collectively making a big impact in terms of diabetes prevention."
On the other hand, he said data from the CDC's National Health and Nutrition Examination Survey indicate that blood glucose, cholesterol, and blood pressure control may be improving. "I don't know if that's attributable to community efforts as much as to physician and patients becoming more aware of targets for diabetes care and slightly better delivery of drugs," Huang said. "I would say that the story is mixed in terms of diabetes prevention and diabetes care.
The researchers noted several limitations to their analysis:
It did not account for possible future changes in diabetes screening rates, which could raise or lower the numbers of people receiving treatment.
It did not account for immigration by people younger than 24.
All individuals with body mass index values of 30 and higher were grouped together, leading to potential underestimation of the future diabetic population and costs.
The model assumed no change in baseline age-specific rates of obesity.
Huang E, et al "Projecting the future diabetes population size and related costs for the U.S." Diabetes Care 2009; 32: 2225-29.
Researchers from Brigham and Women's Hospital at Harvard Medical School in Boston, MA have published a study in the February Journal of Vascular Surgery® stating that disparities in limb salvage procedures may be driven by socioeconomic status (SES) and access to high-volume hospitals.
Senior-author Louis L. Nguyen, MD, MBA, MPH, from the Hospital's division of vascular and endovascular surgery as well as the Center for Surgery and Public Health explained that 958,120 cases containing lower extremity revascularization (LER) or major amputation were reviewed. Data for patients with critical limb ischemia (CLI) also were collected. All patients were 21 years or older and the data was taken from the 2003-2007 Nationwide Inpatient Sample. Findings showed an increased risk of major amputation among minority patients, while adjusting for income, insurance status, hospital-level factors and LER volume.
Several indicators of low SES were clustered by demographic group. Compared with Caucasian patients, Native Americans were the most likely to have income in the lowest quartile. Similar lower median income was seen for Black and Hispanic patients. Non-whites were more likely to be on Medicaid and had lower income than patients with Medicare.
"Minority patients tend to have more comorbidities including diabetes, peripheral artery disease (PAD) and renal failure that influence treatment options as they are more likely to receive care at low-volume and potentially under-resourced hospitals," said Dr. Nguyen. "These factors, independently and in combination, are associated with a greater likelihood of major amputation.
This outcome profoundly impacts the function of CLI patients and their quality-of-life. Our data are similar to other reports that patients with CLI who present to higher volume hospitals are more likely to undergo a limb salvage procedure."
Researchers added that higher-volume hospitals may have more fellowship-trained vascular specialists, established protocols for perioperative care of patients with CLI, and greater access to angiography facilities. Patients who did not have primary payer insurance also had lower income than those with Medicare and were more likely to be minorities. In this current study, non-insurance cases included 24 percent of CLI patients. Demographic trends showed factors associated with amputation (vs. LER) also included older age and male gender.
Compared with patients with the highest income, patients in the lower three income quartiles were at 11 to 34 percent higher odds of undergoing major amputation. Private insurance remained negatively associated with major amputation and patients with Medicaid were at slightly increased odds of major amputation with those with Medicare.
In comparison to patients at the highest volume centers, patients at the lowest volume centers were at 15.2 times higher odds of undergoing major amputation. Patients in the second quartile were also at significantly increased odds of undergoing major amputation and those at hospitals in the third quartile were at 77 percent higher odds of undergoing major amputation compared to those at the highest volume.
"Our findings suggest there are gaps in access to care despite controlling for hospital level factors and procedural volume," added Dr. Nguyen. "Addressing SES, hospital factors and the inverse relationship between LER procedure volume and risk of major amputation for CLI, highlights potential solutions for disparities related to hospital-level factors. Also increasing state and local funding to facilities that provide care to patients at high risk for major amputation may improve professional resources."
Dr. Nguyen added that further analysis of datasets that contain information on referral patterns and utilization of outpatient health care could guide potential interventions which target patients at high risk for PAD and major amputation. He noted that this information also could lead the way for implementing screening protocols focused on risk factor modification and appropriate early vascular surgery referral pathways.
"Given the highly positive impact of preoperative angiography on the likelihood of undergoing a LER procedure, studying the factors influencing the clinical decision to evaluate revascularization options may illustrate reasons for the less frequent use of angiography in certain patient populations and help to more widely implement standard diagnostic protocols," concluded Dr. Nguyen. "Further exploration of these potential mechanisms of disparities both at the patient and the hospital levels may improve limb salvage for the vulnerable population."
Understanding the 2010 ConsensusRecommendations for Diabetic Foot Ulcer Care
By Lee C. Rogers, DPM
Note to the Reader: These articles summarize the "Consensus Recommendations on Advancing the Standard of Care for Treating Neuropathic Foot Ulcers in Patients with Diabetes," authored by Robert J. Snyder et al., published as a supplement to Ostomy Wound Management in April 2010.
Published as a supplement to the April 2010 issue of Ostomy Wound Management was a pivotal reference paper titled, "Consensus Recommendations on Advancing the Standard of Care for Treating Neuropathic Foot Ulcers in Patients with Diabetes."1 The authors are a recognized group of leading experts in the field who convened the consensus panel.
The world's population with diabetes will increase from 171 million to 366 million by 2025.2 In the U.S., there are an estimated 24 million people with diabetes. Up to 25% of those with diabetes will develop a foot ulcer in their lifetimes.3 That translates roughly to 1-2% of the diabetic patients per year.
Diabetic foot ulcers (DFU) and lower extremity amputations (LEA) are a costly problem. In 2007, it was estimated that $30 billion was spent for the care of those two conditions.4
The recommendations from the consensus panel are important because they help to update the standard of care based on a review of 111 studies. The recommendations are divided into three categories: Assessment, Treatment, Advanced Therapies.
In this issue we will look at recommendations on assessment of the diabetic foot ulcer.
Recommendations on Assessment of the Diabetic Foot Ulcer
The team approach to assessment and management of the DFU is recognized as the standard of care. No physician "is an island", and the co-morbidities within the diabetic foot cross multiple physician disciplines. A thorough history should be performed. Since wound healing delays can occur with anemia, renal insufficiency, and uncontrolled blood sugar, a CBC and HbA1c should be performed at baseline. If osteomyelitis is suspected, erythrocyte sedimentation rate (ESR) and (CRP) should be ordered.
The patient's nutritional status should be assessed by history and serum pre-albumin. Historical concerns are unintentional weight loss, chronic alcohol use, and problems chewing or swallowing. Smoking is a risk factor for peripheral arterial disease (PAD) and delays wound healing. One should remember the four A's of smoking cessation: Ask about smoking, Advise to quit, offer Assistance, Arrange follow-up.
Neurologic screening should consist of 10 gram monofilament and 128-Hz tuning fork tests. Vascular evaluation is more complicated. There is no single test that can completely evaluate vascular health. Palpation of pulses or ante brachial index (ABI) cannot be relied upon in this population. The absence of pulses is a good indicator of poor flow, but the presence of pulses cannot rule out arterial insufficiency. The toe brachial index (TBI) is less susceptible to false readings due to diabetic arterial calcification. Skin perfusion pressure (SPP) measures capillary pressure in the skin and is very sensitive at uncovering vascular disease in diabetics as well as predicting wound healing. Transcutaneous oximetry (TCPO2) can validate referral for hyperbaric oxygen. Vascular imaging tests should be performed by an appropriate specialist if there is reasonable suspicion of underlying vascular disease.
The foot examination should include assessment of dermatologic changes, musculoskeletal deformities, and ulcer evaluation. Dermatologic changes can show inflammation by thermometry or thermography. Also, it can reveal ischemia by the presence of purpura, fat atrophy, loss of hair growth, or taut skin. The podiatrist is a key member of the team for understanding the biomechanical abnormalities that lead to ulceration. Range of motion of the ankle and first metatarsophalangeal joints should be assessed for restriction in dorsi-flexion. Inspect for deformities associated with Charcot joint disease.
Radiography is useful to help uncover osteomyelitis or deformities. The foot should be x-rayed at baseline and it is appropriate to perform bilateral x-rays for comparison.
The wound assessment and documentation includes size, depth, shape, probing, undermining, condition of the wound bed, and condition of the periwound area. One should use a standard wound classification scheme. The consensus panel recommends use of the University of Texas Classification.5
Infection is devastating to the diabetic foot and its evaluation is primarily clinical. Heat, redness, pain, and swelling are the classic symptoms. The diabetic neuropathic patient does not always exhibit all those signs, so one should be aware of secondary signs like exudate, delayed healing, discolored granulation tissue, and malodor. Culture should only be taken if the clinician suspects infection.
Posted by: PV Mayer at 06:49 pm 0 comments - Add a Comment Category: Diabetic Foot Ulcer Treatment
Newfoundland and Labrador Auditor Genreral John Noseworthy released his annual report on government departments on Jan. 26.(CBC)
Newfoundland and Labrador is failing to properly diagnose and treat diabetes, according to an annual report released by the province's auditor general Wednesday.
Information from the National Diabetes Surveillance System and The Canadian Diabetes Association shows that 9.3 per cent of the province's population has diabetes - the highest of any jurisdiction in Canada.
Those sources suggest that number will increase to more than 14 per cent by 2020.
But John Noseworthy's report on government departments for the fiscal year ending March 31 said those estimates are probably low.
"Information from physicians relating to diabetes diagnosis and treatment is not tracked. As a result, the prevalence and cost information is understated," wrote Noseworthy. "The Department of Health and Community Services is not doing a good job of fulfilling its leadership role in preventing and managing diabetes."
The province, which has second highest rate of obesity and physical inactivity in Canada, spent about $254 million in 2010 on health care costs related to diabetes.
Noseworthy suggests the cost of diabetes in the province will to balloon to $322 million by 2020, an increase of 27 per cent.
An interesting argument for higher protein low carb diet to treat diabesity.
Irresponsible' doctor declares: 'Fat is your friend'
Duke researcher defends low-carb diets against a barrage of criticism.
By Andrea Weigl andrea.weigl@newsobserver.com
Posted: Monday, Jan. 03, 2011
Clipboard in hand, Dr. Eric Westman strides into the office to see his patients. All of them are overweight. Many of them are diabetic and have high blood pressure or other weight-related ailments.
He scans a list of foods they eat and doesn't bat an eye at their consumption of eggs, sausage, bacon, coffee with heavy cream or pork rinds. He doesn't require them to exercise. He tells one: "Fat is your friend."
With those four words, Westman, an internist who directs Duke University's Lifestyle Medicine Clinic, declares his stance in the often vitriolic low-fat vs. low-carb debate. His research helped spark the 2004 Atkins diet boom, and he is a co-author of "The New Atkins for a New You," which devotes a chapter to the past decade's research on low-carb diets.
Westman seems out of place in Durham, which has been called "the diet capital of the world." Obese people come from afar and spend up to $7,000 a month to shed pounds at The Rice Diet Program Clinic, Structure House and the Duke Diet & Fitness Center. All three clinics prescribe a low-fat, calorie-restricted diet along with exercise.
Meanwhile, Westman runs a one-man clinic out of a Duke office building. Most of his patients live nearby, and the most they have to pay to see him is a health insurance co-pay.
For the past 10 years, Westman and other low-carb researchers have been fighting an uphill battle against the medical consensus that a low-fat, high-carb diet is best.
Low-fat dieters aim to get 65 percent of their calories from carbohydrates, such as whole-grain breads, pastas, fruits and starchy vegetables. A low-fat diet helps you lose weight because you eat bulky foods with fewer calories.
A low-carb, high-fat diet favored by Westman reduces carbohydrates to 30 percent or less. Most of the calories come from fats, protein and low-carb vegetables, such as leafy greens, broccoli and zucchini. The low-carb diet helps you slim because protein and fat leave you full longer so you consume fewer calories.
"Fat is very satiating," Westman said. "Diets that restrict fat, that's a problem. Hunger is the main reason people go off a low-fat diet."
Westman and his colleagues are not saying that low carb is better than low fat. Both diets work because they restrict calories. Research shows that the best diet for someone is the easiest one - based on personal food preferences - to follow. Westman's point is that a low-carb diet is a viable option that has been wrongly maligned by the mainstream medical community.
Those mainstream diet doctors want to make Westman eat his words.
But he and his fellow researchers contend that their findings are solid - more solid than Ancel Keys' 1950s studies that first suggested that a diet high in saturated fat caused heart disease. Keys' theory would be cemented into the American consciousness by the U.S. Department of Agriculture's food pyramid, which critics contend is influenced more by the agriculture industry than by science.
When Westman and others proved that people could lose as much weight on a low-carb diet as on a low-fat one, their detractors asked, "But what happens to their cholesterol?"
When they proved that a low-carb diet decreases LDL, or bad cholesterol, while improving HDL, the good cholesterol, their detractors pointed out that the study followed patients for only six months.
When a two-year study found similar results, those in the low-fat camp still weren't convinced that eating so much animal fat wouldn't kill you in the end.
"There's no doubt that the Atkins diet will lower your cholesterol, weight and blood pressure and get rid of your diabetes, but then what?" asked Dr. Robert Rosati, the cardiologist who runs The Rice Diet Program Clinic, granddaddy of Durham's diet centers.
That's the main criticism of the low-carb research from Dr. Dean Ornish, likely the most outspoken critic of low-carb diets and often a debate opponent of Dr. Robert Atkins. Ornish is president of the nonprofit Preventive Medicine Research Institute in Sausalito, Calif. This research, he says, studies only the diet's effect on the risk factors for heart disease and not its effect on heart disease.
"The Atkins people have never published a study that the diet they recommend actually improves heart disease," he says.
The 'irresponsible' label
This nutrition debate can get so heated that Westman and other low-carb researchers have to defend themselves from being labeled fringe advocates for a fad food plan.
In September, Westman said at a diabetes conference in Sweden that a low-carb diet is better than drugs at controlling type 2 diabetes, which is prevalent among the obese.
Dr. Robert Eckel, an endocrinologist and spokesman for the American Heart Association, then derided Westman on the association's website as a "tremendously biased investigator who is very much in favor of his own work."
When Westman suggested that one way to prove his assertion was to study diabetics on the two diets, Eckel denounced the idea as "irresponsible," concerned about the effect of a high-fat diet on the heart. Eckel later added in an interview: "To manage diabetes long term with an Atkins diet is not worthy of serious consideration."
Others applaud Westman's willingness to challenge conventional wisdom.
"Eric had a sufficiently open mind that he looked into it," said science writer Gary Taubes, author of "Good Calories, Bad Calories: Challenging the Conventional Wisdom on Diet, Weight Control and Disease," which touts the low-carb regimen. "He's really one of a handful of people making this attempt at revolution. Why can't all these doctors be as open-minded?"
Diet research can be complicated. For one thing, a researcher can't always control what a human subject eats or how much he exercises, as he can with a lab rat. Those few studies that have housed and fed people for diet research have been costly - too costly for most researchers. And if people in weight-loss studies don't lose weight, they tend to quit the project, potentially skewing the results.
Other studies, Ornish says, show his regimen can not only reverse heart disease but slow, stop and even reverse the progression of prostate cancer. He also says his methods can even change gene expression - essentially turning on the genes that make someone healthy and turning off those that don't.
Refuting 'old way of thinking'
Westman spends Wednesdays seeing patients who regularly visit his clinic to track their weight loss and other health goals. Patients describe him as a "cheerleader" who offers encouraging words and reading materials.
At 6 feet 1 inch and 190 pounds, Westman, 50, shares tips - how to make low-carb pizza, a cheese plate for dessert and vodka and Fresca drinks as a low-calorie cocktail - culled from following the low-carb diet since 1999.
Westman, who grew up in Madison, Wis., earned his undergraduate degree at Stanford University and then went to medical school at the University of Wisconsin. He married his high school sweetheart, Gretchen, a school librarian in Chapel Hill. They have three children.
He often favors khakis and sports-related T-shirts to encourage exercise chitchat with his patients. On one Wednesday, he wore a "Fear the Tree" T-shirt, a reference to the Stanford marching band's mascot.
Among the patients Westman is seeing is Larry Boone of Durham. The 63-year-old carries about 300 pounds on his 6-foot frame and has diabetes. Boone had been steadily gaining weight while on a diabetic diet so his primary-care doctor sent him to Westman.
Westman scans a list of foods that Boone has been eating the first week on his new diet.
For breakfast, eggs with bacon or sausage, diet cola or coffee with heavy cream. Lunch and dinner have been tuna salad, garden salad, hamburger, grilled chicken, beef stew, turnips, collards and diet cola. For snacks, he's had sugar-free Jell-O, boiled shrimp, deviled eggs and pork skins. Boone's wife, Molly, reports that their refrigerator is the fullest it has ever been and that she made whipped cream from scratch for the first time ever.
When Boone questions his new diet - "I've always been told in the past about butter clogging the arteries," he says - Westman reassures him. "That's the old way of thinking."
Since late August, Boone has lost 41 pounds and been taken off his diabetes medication. He uses only one cane to walk.
Westman hasn't always been a low-carb advocate. He accepted the little he was taught in medical school about nutrition, basically that a low-fat diet is the healthiest.
He began questioning that belief in the late 1990s while treating patients at Durham's VA hospital. He found a fertile topic for research when a patient ignored his advice, went on the Atkins diet and lost weight.
Westman was sure the man's bad cholesterol would increase. Instead, it improved. After a second patient achieved the same results, Westman, already doing research on smoking cessation, was intrigued.
He read "Dr. Atkins' Diet Revolution," (first published in 1972; revised in 1992) which popularized low-carb diets, but Westman found only anecdotal evidence to support the approach.
He wrote to Atkins asking to see what research had been done. Because it wasn't scientific, Westman approached Atkins about testing the diet using randomized controlled trials - the gold standard of medical research. (In such a trial, patients are randomly assigned to one diet or the other to compare the results.)
Atkins and his foundation would go on to pay for Westman's low-carb studies, an association that led Westman to co-author the new Atkins book. Any book royalties are to go into a Duke research account for Westman's work.
"This is new science, and it's going against the mainstream belief," Westman said.
Proof after proof
Westman's team published its first study in 2002. Researchers followed 51 volunteers on a low-carb diet for six months. Forty-one completed the study; all lost weight, and the effect on their cholesterol was favorable.
Two years later, Westman was the co-author of a clinical study that tracked 120 patients for six months. Half were on a low-fat diet; half on low-carb. More of the low-carb patients stayed with the diet; they also lost more weight while improving their cholesterol.
Then Westman studied how people with type 2 diabetes did on a low-carb diet. A 2005 study followed 21 such patients for four months and showed they lowered their blood glucose, allowing some to discontinue or reduce their diabetes medication.
Next, Westman and his colleagues examined whether a low-carb diet or a low-glycemic index diet was better for diabetics. (The glycemic index assigns numerical ratings to carb-rich foods based on how much they increase blood glucose levels.)
The clinical trial followed 84 volunteers for six months and found that a low-carb diet was the winner.
In 2009, Westman's team reported on a study comparing a low-carb diet with a low-fat diet combined with Orlistat, an over-the-counter drug known as Alli or Xenical that blocks fat absorption.
After a year, all 122 patients in the trial experienced similar weight loss, but the low-carb patients had a larger decrease in their blood pressure.
On the horizon is a look at the success rates of people who get to choose a diet to follow. On this project, Westman is helping Dr. William Yancy of Durham's VA hospital, his collaborator on many of the previous low-carb studies.
For his years of work, Westman was chosen "Bariatrician of the Year" in November by the American Society of Bariatric Physicians, a group of medical professionals who use nonsurgical means to treat obese patients.
Low-carb diet craze
Although research continues, the low-carb diet craze came and went.
At the diet's peak in 2004, an estimated 100 million Americans were watching their intake of carbohydrates, fueling a $40-billion-a-year industry. Atkins had died in a fall in 2003, and a confidential medical report about his death was made public later. It showed he weighed close to 250 pounds, classifying him as obese.
The incident illustrates how vitriolic the two sides can be. The report was leaked to The Wall Street Journal by the Physicians Committee for Responsible Medicine, which promotes a vegan diet. In response, Atkins' widow, Veronica, painted the group as the "vegetarian Taliban." She and others say Atkins gained 60 pounds from the glucose and fluids pumped into his body while he was in a coma.
Westman is convinced the controversy surrounding Atkins' death brought the diet's popularity to an end.
"All I know is science did not stop the craze," Westman said. "There was no new science that low-carb diet was bad. It took new science to get it out there. It took no science to take it away."
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
PREVENTION:The Key to Limb Salvage
Over the last two and one half decades, it has become quite clear that Prevention of diabetic foot wounds is the key to avoiding diabetic limb loss. As early as 1986, Edmonds et al. published their study in the Quarterly Journal of Medicine showing that a Multidisciplinary Clinic focused on early intervention, education, and preventive foot care (including footwear) significantly improved rates of recidivism and limb loss.1 Numerous other studies in subsequent years have confirmed these findings.2-6 As we previously discussed in our FootNotes issue dealing with Diabetic Foot Ulcers,24Pecoraro in 1990 demonstrated that nonhealing diabetic foot wounds were one of the most common component causes in the causal pathway leading to lower limb amputations in this population.7 In the setting of neuropathy with loss of protective sensation (LOPS), therefore, any diabetic foot wound poses a serious threat to the well-being of such persons. As Pecoraro also found, eighty-five percent of the diabetes related lower limb amputations occurred subsequent to these non-healing foot ulcers. Thankfully, this does not imply that 85% of foot ulcers go on to amputation! The true percentage most likely lies in the range of 15-20% or so, based on two other important studies.8,9 The important point here is that diabetic foot ulcers (DFU) are a serious complication of the disease and, once present, potentially place the patients’ limb at risk. Equally important, several studies have shown that DFUs also impart a decreased survival risk for these patients when compared not only to non-diabetic persons, but to persons with diabetes without a history of ulceration.8,10-12I can refer you to Jarrod Shapiro's Practice Perfect ezine, A Practice Perfect Podiatric Service Announcement,25 wherein he discussed the morbidity of diabetic lower extremity complications and the role of prevention.
I believe that a Diabetic Foot Prevention Program is not only effective, but should also be amandatory part of the management of High Risk patients. Although primary prevention of limb threatening problems is not always possible, secondary and tertiary prevention of the recurrence or progression of the disease certainly should be practiced.13 Hence, we have seen the development of Risk Stratification schemes from the International Working Group on the Diabetic Foot and from the Veterans Affairs system.14,15The purpose, of course, is to stratify diabetic patients according to their risk for ulcers and amputations; subsequently, the level of risk is used to determine frequency of care, self foot care, and the need for protective “therapeutic “ footwear. In the VA, we have certainly seen a dramatic reduction in the rates of major amputation in the last decade, since fully implementing our Amputation Prevention Program in concert with a close collaboration with our Vascular Surgery colleagues. We cannot save limbs without aggressive detection and treatment of underlying critical ischemia. Figure 1 clearly illustrates this trend for the diabetic population.
Figure 1. VA amputation rates (diabetes only) (Courtesy Department of Veterans Affairs)
Commensurate with the decrease in major amputations, there has been an increase in the number of limb salvaging minor (foot level) amputations. The High/low or major/minor ratio is the best indicator for success in this regard, wherein the smaller the ratio, the better.16Figure 2 shows the major/minor ratios over the last decade as well, with a very nice decline as the number of minor amputations far surpasses the number of major amputations.
Figure 2. Major/minor ratio (VA diabetes cohort) (Courtesy Department of Veterans Affairs)
5 Ps of Prevention
Table 1. The 5 Ps of Prevention
Podiatric Care Regular Visits, examinations and foot care Risk assessment Early detection and aggressive treatment of new lessions
Protective shoes Adequate room to protect from injury; well cushioned walking sneakers, extra-depth, custom-molded shoes, special modifications as necessary
Prophylactic surgery Correct structural deformities: hammer toes, bunions, Charcot Intervene at opportune time
Preventive education Patient education: need for daily inspection and early intervention Physician education: significance of foot lesions, importance of regular foot examination, and current concepts of diabetic foot management
There are five primary areas that are essential to any foot care program designed to prevent lower extremity amputations. (Table 1) These were first reported over a decade ago and still hold true.17
1).Podiatric Carecan be practiced by any foot care specialist interested in management of high risk patients. Such care involves not only regular foot care visits and management of acute or chronic foot problems, but also serves to detect impending problems at their earliest onset. Foot care providers, most commonly podiatrists in the USA, see their patients fairly frequently depending upon their level of risk as mentioned above.
2). Protective or “therapeutic” footwear is considered to be a mainstay of preventive therapy for high risk patients, although there have been conflicting reports on the efficacy of therapeutic shoes.18-20 Nonetheless, it just makes good sense to wear appropriate footwear when a patient has neuropathy, PAD, or a history of ulcers or amputations. In addition to protective footwear, good care also includes.
3). Pressure reducing insoles. These can include simple high quality insoles or custom molded multidensity insoles for feet with deformity or documented high pressures. In this regard, plantar pressure assessments can be made with pressure sensitive contact mats (Pressure Stat®) or computerized analysis systems (Tekscan®).
4).ProphylacticSurgery or reconstructive surgery in diabetic neuropathic patients is now considered to be an important component in the care delivered to persons with deformity and recurrent foot ulcerations. It has been sometimes termed as “surgical offloading” or internal decompression of high pressures caused by bony deformities.21 Obviously, patients must be appropriately evaluated and intervention must occur at an opportune time, unless surgery is needed emergently.
5).Patient and Provider Education is critical for success and has been shown to have a positive impact in reducing ulcer recidivism and the need for amputations.1-5 Patients need to be educated about diabetes management and proper foot care at every encounter. Providers need to be educated about risk factors and their modification, new treatment modalities, as well as emerging principles for care.
An amputation prevention program is not difficult to develop; it just takes a dedicated team of professionals to accomplish the goal.13,17,22 The key word is TEAM. All interested providers are needed, since all have unique talents and experiences. Figure 3 represents my concept of a fully functioning multidisciplinary team. The literature is replete with evidence supporting such a framework and the commensurate reduction in amputations.6,13,23I challenge those of you interested in high risk patients to develop or join such established teams. Although it takes a good deal of time and dedication, the rewards can be not only limb salvaging, but life saving!
Figure 3. Multidisciplinary Framework for an Amputation Prevention Team.
References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on eTalk.
Best regards,
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
REFERENCES
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Bild DE, Selby JV, Sinnock P, Browner WS, Braveman P, Showstack JA. Lower-extremity amputation in people with diabetes. Epidemiology and prevention. Diabetes Care. Jan 1989;12(1):24-31.
Dargis V, Pantelejeva O, Jonushaite A, Vileikyte L, Boulton AJ. Benefits of a multidisciplinary approach in the management of recurrent diabetic foot ulceration in Lithuania: a prospective study. Diabetes Care. 1999;22(9):1428-1431.
Larson J, Apelqvist J, Stenstrom A. Decreasing incidence of major amputation in diabetic patients: a consequence of a multidisciplinary foot care team approach.Diabetic Medicine. 1995;12:770-775.
Malone JM, Snyder M, Anderson G, Bernhard VM, Holloway GA, Jr., Bunt TJ. Prevention of amputation by diabetic education. Am J Surg. 1989;158(6):520-523; discussion 523-524.
Krishnan S, Nash F, Baker N, Fowler D, Rayman G. Reduction in diabetic amputations over 11 years in a defined U.K. population: benefits of multidisciplinary team work and continuous prospective audit. Diabetes Care. Jan 2008;31(1):99-101.
Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation: basis for prevention. Diabetes Care. 1990;13:513-521.
Ramsey SD, Newton K, Blough D, et al. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999;22(3):382-387.
Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes disease management cohort.Diabetes Care. May 2003;26(5):1435-1438.
Boyko EJ, Ahroni JH, Stensel V, Forsberg RC, Davignon DR, Smith DG. A prospective study of risk factors for diabetic foot ulcer. The Seattle Diabetic Foot Study. Diabetes Care. Jul 1999;22(7):1036-1042.
Moulik PK, Mtonga R, Gill GV. Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care. Feb 2003;26(2):491-494.
Iversen MM, Tell GS, Riise T, et al. History of foot ulcer increases mortality among individuals with diabetes: ten-year follow-up of the Nord-Trondelag Health Study, Norway. Diabetes Care. Dec 2009;32(12):2193-2199.
Rogers LC, Bevilacqua NJ. Organized programs to prevent lower-extremity amputations. J Am Podiatr Med Assoc. Mar-Apr 2010;100(2):101-104.
International Working Group on the Diabetic Foot. International Consensus on the Diabetic Foot. Paper presented at: International Working Group on the Diabetic Foot2003; Noordwijkerhout, Netherlands.
Lavery LA, Peters EJ, Williams JR, Murdoch DP, Hudson A, Lavery DC. Reevaluating the way we classify the diabetic foot: restructuring the diabetic foot risk classification system of the International Working Group on the Diabetic Foot. Diabetes Care. Jan 2008;31(1):154-156.
Wrobel JS, Robbins J, Armstrong DG. The high-low amputation ratio: a deeper insight into diabetic foot care? J Foot Ankle Surg. Nov-Dec 2006;45(6):375-379.
Frykberg RG. Team approach toward lower extremity amputation prevention in diabetes. J Am Podiatr Med Assoc. Jul 1997;87(7):305-312.
Reiber GE, Smith DG, Wallace C, et al. Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial. Jama. May 15 2002;287(19):2552-2558.
Uccioli L, Faglia E, Monticone G, et al. Manufactured shoes in the prevention of diabetic foot ulcers. Diabetes Care. 1995;18(10):1376-1378.
Chantelau E. Therapeutic Footwear in Patients With Diabetes. Journal of the American Medical Association. 2002;288(10):1231-1232.
Frykberg RG, Bevilacqua NJ, Habershaw G. Surgical off-loading of the diabetic foot. J Vasc Surg. Sep 2010;52(3 Suppl):44S-58S.
Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-Oct 2006;45(5 Suppl):S1-66.
Larsson J, Apelqvist J, Agardh CD, Stenstrom A. Decreasing incidence of major amputation in diabetic patients: a consequence of a multidisciplinary foot care team approach? Diabet Med. Sep 1995;12(9):770-776.
A group which campaigns on behalf of people with diabetes has welcomed HSE plans to introduce a national diabetes foot care screening programme in 2011.
Just last September, Diabetes Action's ‘Half the Services, Half the Care' campaign drew attention to the high levels of foot ulcers and lower limb amputations being carried out among people with diabetes in Ireland, in an attempt to secure a foot screening programme for those with the condition.
"Between 2005 and 2009, 1,579 people with diabetes in Ireland underwent a below knee amputation and nearly 6,000 people with diabetes developed a foot ulcer requiring inpatient treatment - this cost the government an estimated €239 million," explained Kieran O'Leary, CEO of the Diabetes Federation of Ireland.
He welcomed the HSE's commitment of €1 million this year to develop a foot care screening programme and insisted that if this is properly implemented, it will ‘advance diabetes care greatly, improve the quality of life of patients and, in time, make huge financial saving for the Government'.
The ‘Half the Services, Half the Care' campaign called for an initial 20 podiatrists to be employed to work with people with diabetes and provide a national foot care screening programme, arguing that the service would pay for itself on the basis of each podiatrist preventing just three inpatient foot ulcer treatments each year.
Commenting on the new programme, Dr Ronan Canavan, a consultant endocrinologist at St Vincent's Hospital in Dublin, said that this would mark a ‘major first step' in reducing the current level of foot ulcers and lower limb amputations in this country ‘by up to 70%'.
"These occur largely because of a lack of early detection and timely intervention of foot problems. This is a very positive move towards developing a service that will impact on the lives of thousands of people with diabetes," Dr Canavan said.
Meanwhile, Diabetes Action also welcomed HSE funding of €4 million to develop a national screening programme for diabetic retinopathy - an eye condition affecting the sight of one in three people with diabetes in Ireland.
"Diabetic retinopathy affects about 60,000 in Ireland, and we will be closely watching the implementation of both these programme," the group said.
Diabetes Action is an advocacy group formed by representatives from the Diabetes Federation of Ireland, the diabetes section of the Irish Endocrine Society (IES) and the Irish Diabetes Nurse Specialist Association (IDNSA)
The typical course for a patient with a "diabetic foot" generally ends with a trip to the operating room to have it removed. However, at last month's meeting of the International Cellular Medicine Society, it was announced that a patient with gangrene of the foot related to diabetes was able to avoid amputation through the use of adult-derived stem cells.
The patient, a 72-year old man from South Korea, had the classic podiatric complications of diabetes, including change of color, necrotic tissue, and deep wounds. Apparently, he was about to undergo an amputation of the affected extremity when he was referred to a South Korean company, RNL Bio, that took stem cells from the patient himself and infused about 300 million of them into each foot.
The results are quite remarkable :
"Just 10 days after Cho’s stem cell injection, there was 70-80% improvement in pus and wounds; an improvement of 90% was exhibited 20 days later. As the wounds began to heal, the pain and tingling was no longer evident. "
Dr. Jeong Chan Ra, Chairman of RNL Bio stated, "In cases like Cho's condition, patients can gain hope through stem cell therapy rather than facing the worst case scenario of having to get one's leg amputated. There is continuous hope until the day comes where stem cell therapy will be available to anyone worldwide."
RNL Bio has conducted Phase II clinical trials using adult-derived stem cells for Buerger’s disease, osteoarthritis and one Phase I trial for spinal cord injury.
Dan Hill, as told to Brittany Mahaney, National Post · Monday, Dec. 27, 2010
My dad died of diabetes complications. It was really painful to see him die that way. He suffered through three amputations and I was diabetic as he was dying. My dad was an incredibly bright and powerful man. You know the way you kind of look at your father like he’s omnipotent, larger than life? My father was a very powerful guy in every manner of speaking and [it was hard] to see him reduced to being so helpless and to realize a lot of it was because he didn’t take care of himself.
He suffered through an era when diabetes was thought of as a stigma or weakness. Because my dad was so proud, he insisted we keep his diabetes a secret. That made it worse because by not saying he was diabetic, he was inhibited in behaving in health-conscious ways.
I’m 56 years of age; I’ve had diabetes since at least 1994. I was diagnosed in ’96, but I didn’t know I had it for two years before. A lot of people are diabetic without knowing. I witnessed first-hand the slow deterioration of my father and suffered when I first had diabetes, because it was more psychological. I didn’t want people to suffer the way my dad suffered, and I realized that a lot is preventable. I wanted to somehow be a voice so people could say: “Well this guy is diabetic and he’s coping reasonably well because he’s following the protocols, which really aren’t that hard.”
I’m not saying I’m a perfect role model, because I’m not, but I’m a really active guy. I run 10 miles a day; I write books; I write articles; I put out records; I’m touring all the time. Frankly, I feel a lot stronger and healthier with a lot more energy at 56 than I did at 36. If you follow the rules, you can have an exceptionally healthy life. A lot of the rules you should follow are the healthy things we all should be doing anyway.
I was a competitive track athlete as a kid, so I knew a lot of the tricks to training, but seeing my dad lose his legs scared me so much that I started running way more. It literally made me celebrate my legs because I didn’t want to lose them. Running made me realize all those things we take for granted. We take our health for granted until it’s taken away from us. As I saw it taken away from my dad, I felt it was taken away from me. To fight back, I embraced exercise and a good diet.
Stress is really bad for diabetes. It’s bad for all of us, of course. Some stresses are unavoidable — it’s just part of life. One of the things I do to avoid stress is not work with people that I don’t really like or that drive me crazy. I don’t care if they’re the biggest artists in the world. If I get asked to fly to L.A. to write with someone I don’t like and I know is a real pain in the ass, then I won’t do it. You make choices and maybe because I’ve worked for so long, I have the right to say I’m not going to do this. I don’t get caught up in the drama; you have a choice.
While I’m touring, I make sure I’m staying in a hotel that has a really good workout room. I very often pack diabetic-friendly food. I’ll pack a whole whack of almonds and oatmeal. Everyone teases me because I have so much stuff, but there’s no way around it. I’m really careful about not eating quick sugars unless my body needs them.
The key is to take it one day at a time, slowly evolve, and not get down on yourself if you slip — and I slip. Last night, I had too much banana cake. So I don’t want to act like I’m this perfect person that doesn’t slip, because we all slip. You can’t beat yourself up for it and you just say: “Well that was yesterday and today’s today.”
• Dan Hill is the goodwill ambassador for the Canadian Diabetes Association (diabetes.ca).
Excellent articles from the folks at Diabetes in Control.
Top Articles of 2010
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More evidence that preventative diabetic foot care saves limbs and saves lives.
How Long-Term Primary Podiatric Care Can Reduce Diabetic Pedal Complications
VOLUME: 23PUBLICATION DATE: Dec 01 2010
Issue Number:
12 December 2010
Author(s):
Ronald Sage, DPM
At the recent annual meeting of the American Podiatric Medical Association (APMA), Gibson and colleagues presented an elegant study confirming what is well known to all podiatric physicians. In patients with diabetes, the study authors noted that “care by podiatrists appears to prevent or delay lower extremity amputation and hospitalization.”1
Podiatric care may include the use of advanced limb salvage interventions in the presence of limb threatening infections or ischemia. However, no matter how exciting these advances are, primary podiatric care on a long-term basis remains the mainstay to prevent or minimize the complications that require advanced interventions. Effective long-term primary podiatric care is far more desirable for the patient than the risk and disability associated with aggressive limb salvage.
Foot surgeries, wound care and vascular interventions are necessary elements of limb salvage. Equally important is the fact that education, prescription shoes, orthotics and callus care at regular intervals are required to prevent further significant ulcerations, infection, hospitalization and possible amputation. Such care is essential after surgery for ulcerative lesions and must be provided by a podiatric physician who is willing to take on longitudinal care for high-risk patients with diabetes.
What The Literature Reveals
High-risk patients with diabetes continue to present on a daily basis at our clinics at the Edward Hines, Jr. Veterans Affairs Hospital and the Loyola University Medical Center. In addition to patients at a high risk of ulcers, others with low-grade chronic ulceration can remain free of infection and avoid amputation if they are under regular podiatric care.
My group demonstrated this in a 2001 review of 233 patients admitted to our hospitals with foot ulceration.2 Ulcerated patients in this series who received care in a podiatry clinic were far less likely to undergo surgery or amputation in comparison to those who had not received podiatric care prior to admission for infected foot ulcerations.
There are approximately 24 million people in the United States with diabetes and 1.6 million new cases are diagnosed each year.3 Researchers have estimated that 15 percent of these patients will have a diabetic foot ulcer during their lifetime, automatically putting them at high risk for further ulceration or amputation.4
Diabetes is the most frequent cause of renal failure with over 178,000 people on chronic dialysis.3 A recent study by Ndip and colleagues indicated that 95 percent of a group of 466 patients on dialysis in the United States and United Kingdom were at high risk for lower limb complications.5 In another study involving 150 patients on dialysis and 150 patients with previous foot ulceration or amputation, Lavery and co-workers found that only 30 percent of the study patients received preventative podiatric care.6
As we advance in our abilities to utilize sophisticated diagnostic and surgical interventions for treating diabetic foot complications, we must not lose sight of the fact that longitudinal primary podiatric care remains the cornerstone of prevention. Primary podiatric evaluation and management services should be a part of all diabetes care programs to prevent or minimize first episodes of diabetic foot ulceration and limb-threatening infection.
Such services are even more essential for patients with complications like renal failure or previous limb threatening ulceration and infection. Advanced healing and reconstructive techniques have little value to the patient if a subsequent focal pressure callus leads to ulceration and further limb-threatening infection. Diabetic neuropathy and vascular disease associated with even minor foot deformity are chronic conditions requiring longitudinal care.
Case Study: Underscoring The Impact Of Preventive Care Over Two Decades For A Woman With Type 1 Diabetes
The patient is a 62-year-old woman with type 1 diabetes, which is well controlled. She has received regular care at a podiatry clinic since 1989. She has received education about the importance of good control and the potential for foot complications. She is very attentive to her diabetes care.
In spite of efforts to control her diabetes, she has a 45 pack-year history of tobacco use and continues to smoke on a limited basis to this day. She runs a part-time catering business and is active in community affairs so she spends a fair amount of time on her feet.
As I previously noted, the patient’s podiatric care dates back to 1989 when she ulcerated her right fifth toe. She presented with an absence of pedal pulses and received a vascular consult. The vascular surgeon identified significant vascular disease and performed a femoral popliteal bypass. Her toe required amputation but healed uneventfully after the bypass.
The patient started developing an ulcerating, painless callus under her first metatarsal head shortly after the toe healed. Conservative measures failed to resolve the callus so the surgeon performed a tibial sesamoidectomy. She healed and the callus resolved for a period of time. The callus eventually recurred within a year and ulcerated again. Treatment for the ulceration consisted of debridement, antibiotic ointment, gauze dressings and prescription footwear. It resolved within a month.
Since that time, the patient has been wearing prescription shoes and orthotics, and has podiatric evaluation and management on a regular basis. Her visits include callus care every two to four weeks for the past 20 years. The frequency of her visits has depended on her activity level and the observed thickness of the keratosis along with evidence of intradermal hemorrhage or pre-ulcerative breakdown.
If she goes more than three weeks without a podiatric visit, the first metatarsal callus ulcerates in spite of her constant use of prescription footwear. Without frequent callus care, prescription footwear and education about her foot risks, there is little or no question that she would develop serious ulceration, infection and possibly require amputation arising from this painless, chronic pressure keratosis.
In addition to the aforementioned chronic plantar callus on the first metatarsal, the patient also has a stage 3 Charcot joint on her left foot and a third hammertoe with a chronic distal keratosis and history of ulceration. She has worn inlay depth shoes with custom multidensity accommodative insoles for nearly 20 years.
How The Podiatrist Addressed A Navicular Fracture Suffered By The Patient
In 2006, the patient sustained a minor left foot injury, which resulted in a relatively painless swelling across the top of the foot. She called for an office visit within 48 hours of the injury and presented the next day. An X-ray demonstrated a navicular fracture, which split the bone in two fragments. One of the fragments displaced dorsally and tented her skin, causing the swelling. Eventually, this tenting produced a 4 to 5 cm patch of ischemic necrosis.
She clearly needed excision of the fragment and debridement of the necrotic tissue but she had non-palpable pulses. The patient had a collapsed arch, which was consistent with a diagnosis of Charcot joint. There were no plantar prominences. The podiatrist determined that the risks of an extensive reconstruction outweighed the potential benefit.
Before undergoing any foot surgery, the patient received a vascular consult. She had extensive iliac occlusion on both sides and underwent an aortobifemoral bypass. Her peripheral circulation improved. The podiatric surgeon debrided the ischemic patch and excised the navicular fracture fragment.
We subsequently utilized vacuum assisted closure and immobilized her foot in bulky soft dressings for approximately six weeks. She did not undergo any extensive reconstruction of her Charcot joint other than excision of the displaced fracture fragment.
She has remained stable and plantigrade. The patient has demonstrated no plantar prominences and no ulceration of the left foot to date, except for a distal third toe ulcer, which resolved with local care. She received a prescription custom orthotic along with inlay depth shoes.
The patient continues her regular podiatric visits. There have been no significant ulcerations or infections since 2006. At each visit, she receives encouragement for her diligent efforts to control her diabetes, reminders about the adverse effects of smoking and advice to inspect her feet frequently. The physician evaluates vascular status, sensation, skin condition and deformities at each visit. Her pressure calluses undergo evaluation for ulceration and the podiatric physician pares down her calluses. The podiatrist inspects her shoes and orthotics, and provides prescriptions for footwear replacement as needed.
Over the years, the patient has become quite knowledgeable about her foot condition and the need to observe and seek attention for any foot abnormalities she detects between visits. Her clinical course to this date has been marked by several limb-threatening complications of diabetes that could have led to major amputation. However, self-examination and early intervention have minimized her morbidity.
Recognizing Conditions That Increase Amputation Risk
This patient has exhibited loss of sensation, deformity and a past history of ulceration, which places her in a high risk category for amputation risk, according to the International Working Group on the Diabetic Foot.7 The patient also has peripheral vascular disease.
According to the American Diabetes Association, the following conditions are associated with an increased risk of amputation:4 • peripheral neuropathy; • altered biomechanics; • pressure callus; • limited joint mobility, bony deformity, severe nail pathology; • peripheral vascular disease; and/or • a history of ulcer or amputation.
Again, the patient exhibited virtually all of these findings. She potentially could have undergone bilateral amputations but her longitudinal podiatric medical, orthotic and surgical care for the past 21 years has enabled her to reduce her risk of lower extremity amputation.
Dr. Sage is a Professor and the Chief of the Section of Podiatry at the Department of Orthopaedic Surgery and Rehabilitation at the Loyola University Stritch School of Medicine in Maywood, Ill.
Dr. Steinberg is an Associate Professor in the Department of Plastic Surgery at the Georgetown University School of Medicine in Washington, D.C. He is a Fellow of the American College of Foot and Ankle Surgeons.
For further reading, see “How To Address Vascular Complications With Lower Extremity Wounds” in the July 2008 issue of Podiatry Today. To access the archives, visit www.podiatrytoday.com.
References:
1. Gibson TB, Driver VR, Wrobel J, Christina JR, Bagalman E, DeFrancis R, Garafoulis MG, Carls GS, Wang SS. Podiatrist care and outcomes for patients with diabetes and foot ulcer. Presented at 98th Annual Scientific Meeting of the American Podiatric Medical Association, July 15-18, 2010, Seattle, Wash. 2. Sage RA, Webster JK, Fisher SG. Outpatient care and morbidity reduction in diabetic foot ulcers associated with chronic pressure callus. JAPMA 2001; 91(6):275-291. 3. Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2007. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta, 2008. 4. Mayfield JA, Reiber GE, Sanders LJ, Janisse D, Pogach LM. Preventive foot care in people with diabetes, technical review and position statement. Diabetes Care 1998; 21(12):2161-2179. 5. Ndip A, Lavery LA, LaFontaine J, Rutter MK, Vardhan A, Vileikyte L, Boulton AJM. High levels of foot ulceration and amputation risk in a multiracial cohort of diabetic patients on dialysis therapy. Diabetes Care 2010; 33(4):878-880. 6. Lavery LA, Hunt NA, LaFontaine J, Baxter CL, Ndip A, Boulton AJM. Diabetic foot prevention: a neglected opportunity in high-risk patients. Diabetes Care 2010; 33(7):1460-1462. 7. International Working Group on the Diabetic Foot. Available at http://www.iwgdf.org/ .
Last week we talked to Dr. Howard Umansky DPM, founder of the Diabetes Rural Outreach Project (DROP), a telemedicine program designed to remotely monitor diabetes patients in rural areas. All with the goal of eliminating amputations.
Here’s a transcript of our conversation.
mhealth360: Explain DROP and its goals. How did you get the program started?
Dr. Umansky:DROP is a privately funded program designed to identify, monitor and treat diabetes patients in rural areas who are at risk for gangrene and lower extremity amputation. The program grew as an adjunct to a mobile service I started 25 years ago to provide doctors to homebound patients in underserved areas.
Specifically, it started when one of our bed-bound patients with a decubitus ulcer on her heel was referred to the emergency room by a visiting nurse. We had managed to close the ulcer twice but it had reopened and was infected. She was transported to the hospital by ambulance and her leg was amputated. She was 29 years old at the time. I have no doubt that the ulcer would have been treated successfully but we weren’t able to monitor her closely enough. DROP started very shortly after that to insure that there wouldn’t be another case like that one. Many of our patients were 80 miles or more from the closest doctor or service area and I felt we needed better communication and more frequent monitoring. We had a large diabetic population to contend with so we had to create a better system.
We started by identifying the patients who were at greatest risk for ulcers and amputation. We then put monitoring systems into their homes. If they had Internet access, we would use web cams. If they didn’t, we would use videophones that worked off the standard phone line. A nurse would then go out to the patient’s home to explain how to use the equipment. In most cases, we were able to explain the equipment to the patients themselves. In situations where that was not possible, we would use a surrogate – a relative or neighbor, someone we could count on at a specific time to help us monitor the patient. This allowed us to keep potential ulcers, open wounds or infections under a close watch. The results have been excellent and I am very pleased with the program.
mhealth360: Can you tell us how many patients you started with, how it’s grown, and if you plan to see it grow any further?
Dr. Umansky: DROP has approximately 1,000 diabetics being monitored at the present time. We started five years ago with about 65 patients being monitored and have grown from there. We draw most of our patients from Mobile Health, which provides doctors for home visits. Mobile has a patient load of about 20,000 in the southeastern U.S. so we are continuing to grow. We are also expanding our monitoring program outside the United States to coordinate with our wound care center in Barbados and we will be opening a diabetes wound center in central China at the end of this year. The technology will allow us to monitor any of our patients from anywhere. I would like to be able to use our service as a resource for any physician with at-risk diabetic patients.
mhealth360: Did you see any barriers with people not getting the technology or understanding it?
Dr. Umansky: The first problem we had was that we were using web cams. We needed Internet access, which was problematic in the beginning due to lack of Internet connectivity in some rural locations. We then fixed that with videophones that worked on a standard phone line. Once we did that we really had no other problems. Our nurses were very thorough in training the patients and the surrogates in how to use the equipment.
mhealth360: How did the patients react to the program?
Dr. Umansky: The patients were very happy when we approached them with the idea of putting a monitoring system in their homes. I think they were relieved, knowing that someone would be checking on them more frequently. Many of the patients were intimidated by the equipment initially, but we made sure that they were comfortable with using it and we would frequently re-train them at the beginning until we were confident that they could use the system. Allowing them to be an active partner in their treatment I think was also beneficial psychologically.
mhealth360: Are you measuring outcomes for this?
Dr. Umansky: Yes. As a little background, about 60-70 percent of diabetic patients will experience some form of neuropathy, which is a loss in sensation. When they do that they’re more prone to developing a wound. Once they develop a wound it’s a slippery slope, which can lead to amputation. So generally you can expect that you are going to have some percentage of patients that will end up with an amputation. Since 2005 when we started, we’ve had no amputations at all.
And all of that I think is due to the fact that we respond very quickly and we keep our patients monitored very closely. I think that this program, not only the DROP program, but telemedicine in general, is a model for outcome-based medicine. The physician has better communication and consequently, far more control over patient outcomes.
Beyond the outcome-based medicine, there’s also the cost-benefit. A lower extremity amputation in the life span of a patient can cost almost a million dollars when you factor in surgery, rehabilitation, prosthetics, medication, and that’s not taking into account the financial consequence of disability and loss of independence. For the patient, a diabetic with a lower extremity amputation has a 50% chance of losing the other limb within two years and the five-year mortality rate after amputation is just under 50%. This mortality rate is actually higher than many types of cancer. If you can prevent amputation, you are saving an enormous amount of money. If I look at our patient load alone, eliminating two amputations saves $2 million. The cost of treating an amputation is too high in comparison to the cost of preventing it.
mhealth360: From what we understand there really is no reimbursement infrastructure for telemedicine or remote doctor visits. Are things changing and are you seeing reimbursement for these models?
Dr. Umansky:Reimbursement is probably the biggest barrier. The people I know who are doing telemedicine are doing it with the idea that they will be able to show insurance companies, Medicare, Medicaid, that this is really saving money. So right now it’s a goodwill thing, but I think that shortly people will start to realize that telemedicine can save both time and money while providing a better result, and for essentially a very small start-up cost when you consider the cost of disability.
mhealth360: What is your biggest obstacle in this program?
Dr. Umansky: The largest obstacle, I think, is the start-up cost in terms of the hardware, especially since we’re dealing with a lot of patients who are poor and we know we’re not getting reimbursed. So we need to consider, what’s the bottom line and what can we use to get as many monitors out there and do this while keeping costs down. We expect to do that at a fairly low cost and we’ve been successful, but it means reallocating dollars from other places to cover the cost.
For a lot of hospital-based telemedicine practices the equipment they use is more sophisticated than what we have and more costly. I think that may be one of the reasons fewer people are going into it. They’re looking at costs and saying, “Well I’m not sure. I’m not getting reimbursed for this and I don’t know if I want to put out that kind of money just yet.” So right now it will be on the shoulders of the people who are doing it to say the outcomes are well worth it.
mhealth360: Have you used telemedicine for any other diseases or areas?
Dr. Umansky: Actually, we haven’t because this program is aimed at preventing amputations. The first people who I knew that did it were two doctors in Denmark at Aarhus University named Larsen and Clemenson. They monitored foot problems using telemedicine and had great success with it. In Hong Kong, Prince of Wales Hospital did likewise a few years ago with good results. In Madrid, a nephrology practice was monitoring home dialysis patients and I have read articles in which telemedicine is being used for cardiology, dermatology, primary care, mental health, post-op follow-ups, the list goes on and on.
mhealth360: Is it a challenge for doctors to balance their time between clinic patients and telemedicine patients? Especially when it comes to reimbursement?
Dr. Umansky: I think that once there’s reimbursement for telemedicine, that’s not going to be a problem. We also use wound care nurses to do a lot of the basic monitoring for us. If there is a problem developing, the nurses can get that information to us so that appropriate treatment is started immediately. I don’t think it would be possible to devote an inordinate amount of time to monitoring, but the nurses triage the cases and give us the opportunity to treat a problem before it turns into something that needs more radical intervention.
This requires a bit of time management, but once it starts getting reimbursed that will become less of a problem. But for right now it’s setting aside some un-reimbursable time and that is a problem. From the outcome-based standpoint, I think any doctor that is using telemedicine understands how worthwhile it is.
mhealth360: Why do you believe telemedicine hasn’t become more adopted than it is now?
Dr. Umansky: Lack of reimbursement, the cost of implementation, and the time needed to adapt to a different system. All of those things make it unappealing to someone whose hours are already completely spoken for. From the insurance side, reimbursement will be a thorny issue at a time of exploding health care costs. But if I can go back to our patient who’s leg was amputated, more money was spent on the ambulance ride and the initial ER visit than would have been spent treating that wound for 6 months, assuming we needed that long to close it.
Once it is understood that technology will allow for better care, better outcomes and far better communication between doctor and patient, and at a lower cost, it will also be understood that there is really no down side to it.
mhealth360: What about patient engagement? Does this help with that?
Dr. Umansky: Yes, particularly when you’re talking about people who don’t have access to the healthcare system. This does engage them and makes them part of the system again. We’ve heard from so many people that, “I don’t know how to get in… It’s seventy miles to the nearest doctor… I’m going to have to ask my neighbor.” They don’t have to do that now. We know you’re bedbound and that’s ok, you’re still connected to us and we’re still connected to you. And I think that makes an enormous difference. Not only in outcomes, but also in how patients feel about their care. And how involved they are and I think that’s really important also.
mhealth360: Where do you see the future of this movement going? What about the intersection of mobile health and telemedicine?
Dr. Umansky: Telemedicine is the future of medical care. It is also the gateway to preventive care, which will help screen patients, catch disease processes earlier, allow more immediate implementation of treatment, and save time and money while doing it. For patients intimidated by doctors and hospitals, it allows a consultation while in familiar surroundings. For caregivers, the transportation burden is lifted. And for people in remote areas, geography becomes far less of a problem.
Will traditional medicine be replaced? No, but it will be transformed as more delivery systems will be developed to bring medicine directly to the patient. Some of the traditional barriers between doctor and patient will be changed but to the benefit of both. It is an exciting time.
Half of U.S. Could Have Diabetes or Pre-Diabetes within Ten Years
More than half of Americans will have diabetes or be prediabetic by 2020 at a cost to the U.S. health care system of $3.35 trillion if current trends go on unabated, according to analysis of a new report released last week by health insurer UnitedHealth Group Inc....
Diabetes and prediabetes will account for an estimated 10% of total health care spending by the end of the decade at an annual cost of almost $500 billion -- up from an estimated $194 billion this year, according to the report titled "The United States of Diabetes: Challenges and Opportunities in the Decade Ahead."
The average annual health care costs in 2009 for a person with known diabetes were about $11,700 compared with about $4,400 for non-diabetics, according to new data in the report drawn from 10 million United Healthcare members.
The average annual cost nearly doubles to $20,700 for a person with complications relatedto diabetes, the report said.
Diabetes, which is reaching epidemic proportions and is one of the fastest-growing diseases in the United States, currently affects about 26 million Americans. Another 67 million Americans are estimated to have prediabetes, with more than 60 million unaware that they have the condition, according to UnitedHealth.
The 52-page UnitedHealth report also focuses on the growing obesity epidemic as that condition is a leading cause of diabetes.
The authors of the report contend the skyrocketing cost forecasts are not inevitable but only if the crisis is tackled aggressively, including early intervention to prevent prediabetes from becoming diabetes.
"Because diabetes follows a progressive course, often starting with obesity and then moving to prediabetes, there are multiple opportunities to intervene early on and prevent this devastating disease before it's too late," Deneen Vojta, senior vice president of the UnitedHealth Center for Health Reform & Modernization, said in a statement.
The report also focuses on obesity and its relationship to diabetes. Being overweight or obese is one of the primary risk factors for diabetes, and with more than two-thirds of American adults and 17 percent of children overweight or obese, the risk is clearly rising. In fact, over half of adults in the U.S. who are overweight or obese have either prediabetes or diabetes, and studies have shown that gaining just 11-16 pounds doubles the risk of Type 2 diabetes and gaining 17-24 pounds nearly triples the risk.
"What is now needed is concerted, national, multi-stakeholder action," Simon Stevens, chairman of the UnitedHealth Center for Health Reform & Modernization, said in a statement. "Making a major impact on the prediabetes and diabetes epidemic will require health plans to engage consumers in new ways, while working to scale nationally some of the most promising preventive care models." Stevens added.
If solutions for tackling the epidemic offered in the report were adopted broadly and scaled nationally it could lead to cost savings of up to $250 billion over the next 10 years, according to the UnitedHealth analysis.
Another stellar primer on DFU basics by Dr. Fryberg
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
Diabetic Foot Ulcers: Don't Forget the Basics!
Click the image above for larger view.
The most characteristic lesion associated with the diabetic foot is the foot ulcer (Figure 1). Diabetic foot ulcers (DFU) are certainly nothing new – they are vividly described in very old medical literature exactly as we would describe them today. Adjectives such as painless, deep crater-like center, hypertrophic callus on the borders, with varying degrees of granulation and necrotic tissue come to mind from the description by Mott published in 1818.1With the increasing number of persons with both type 1 and type 2 diabetes mellitus (DM) around the globe, the numbers of associated foot ulcers will also show a commensurate increasing frequency. Indeed, every region in the world already seems to be burdened with this chronic complication of diabetes. Most importantly, we must recognize the close association between foot ulcers, infections, and amputations in this at-risk population. Pecoraro published his classic study of component causes leading to diabetes-related amputations in 1990.2The three most common component causes found in the causal pathway to amputation included neuropathy, ulceration, and wound healing failure. In fact, 85% of the amputations studied had a foot ulcer in the pathway leading to the amputation. This is not to infer that 85% of DFUs lead to amputation. However, several studies have indicated that 15 to 20 percent of ulcers go down the pathway to amputation due to subsequent infection and/or ischemia.3,4
The causal pathway to diabetic foot ulceration was similarly studied and published in 1999.5Among neuropathy, ischemia, infection, callus, deformity, and trauma, the most frequent constellation of component causes found in this study were neuropathy, deformity, and trauma. This is not surprising, since neuropathy seems to be the critical component underlying most diabetes related lower extremity complications. A very common clinical scenario that exemplifies this pathway would involve that typical long- standing diabetic patient with loss of protective sensation (LOPS) who has a simple hammer toe deformity. After wearing a new pair of shoes for several hours, a blister had developed on the toe and was unrecognized until that night when the patient removed the shoes and noticed the bloody stain on his socks. This is the good scenario. All too often, people with LOPS don’t recognize the wound until infection has set in or it starts to smell. (Figure 2) In these late cases, hospitalization is usually required, as is surgical drainage or debridement.
Recognition of associated risk factors for DFU helps us manage the lesions more effectively, as well as to assist in the prevention of new or recurrent lesions. While there have been numerous other studies investigating putative risk factors for DFU (i.e. HgbA1c, smoking, prior amputation, PAD, education, footwear, etc.), the basic tenets of treatment for any DFU remain the same.6While simplification is not always good in the management of patients with potentially limb threatening ulcers, condensing the basic components of care facilitates their systematic implementation. Of course, a thorough systematic history and examination is a necessary precursor to treatment. For instance, if one does not systematically consider the influence of underlying ischemia in a chronic non-healing wound, he/she might not do a thorough diagnostic evaluation for vascular disease. The same is true for occult osteomyelitis underlying a chronic wound of long duration. Much has recently been written about the efficacy of advanced therapies in the management of recalcitrant ulcers.6,7,8,9,10 Nonetheless, advanced therapies must be considered as adjunctive to standard, good wound care. Would anyone consider applying a tissue substitute product to an infected, ischemic wound? Of course not, because the treatment would be doomed to failure unless the primary components of infection and ischemia had been first resolved.
By no means is this listing of diagnostic and treatment parameters meant to be exhaustive. To the contrary, it is meant to be rather straightforward and logical so that it can be easily remembered. After all, you won’t always have a wall chart or pocket guide in front of you as you are assessing a patient and determining the extent of pathology and necessary treatment for a diabetic foot ulcer. I can honestly say that for every such patient that I treat, these same six basic tenets come to my mind. I go through them systematically, so that I can be sure to evaluate the important parameters and provide the necessary treatment regimen. A thorough, systematic evaluation will ascertain the important underlying pathology and will therefore facilitate appropriate treatment. It’s really that simple (if managing a diabetic foot lesion can really be considered simple)! Treating the majority of these wounds does not have to be a daunting or complex task. Sometimes, the most important aspect is to make the proper assessment and then, as circumstances warrant, make the appropriate referrals. It is well established that a multidisciplinary team approach will lead to the best outcomes for diabetic foot ulcers.12
Although classification of the DFU has not been mentioned in this FootNote, a proper evaluation and subsequent treatment will still most often lead to a successful outcome. Nonetheless, there are several wound classification schemes in common usage around the world that can not only classify a wound, but also aid in appropriate communication, treatment, and prediction of outcomes. That will be a topic of a future FootNote.
References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on this article.
Best regards,
Robert Frykberg, DPM, MPH PRESENT Editor, Diabetic Limb Salvage
REFERENCES
Mott V. A case of circular callous ulcer in the bottom of the foot. Med Surg Register.1818.
Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation: basis for prevention. Diabetes Care. 1990;13:513-521.
Ramsey SD, Newton K, Blough D, et al. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999;22(3):382-387.
Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes disease management cohort.Diabetes Care. May 2003;26(5):1435-1438.
Reiber GE, Vileikyte L, Boyko EJ, et al. Causal pathways for incident lower-extremity ulcers in patients with diabetes from two settings. Diabetes Care. 1999;22(1):157-162.
Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-Oct 2006;45 (5 Suppl):S1-66.
Steed DL, Attinger C, Colaizzi T. Guidelines for the treatment of diabetic ulcers. .Wound Repair Regen. 2006;14(6):680-692.
Kirsner R, Warriner RA, Michela M, Stasik L, Freeman K. Advanced Biological Therapies for Diabetic Foot Ulcers. Arch Dermatology. 2010;146(8):857-862.
Snyder RJ, Kirsner RS, Warriner RA, 3rd, Lavery LA, Hanft JR, Sheehan P. Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manage. Apr 2010;56(4 Suppl):S1-24.
Lipsky BA, Berendt AR, Deery HG, et al. Diagnosis and treatment of diabetic foot infections. Clin Infect Dis. Oct 1 2004;39(7):885-910.
Rogers LC, Andros G, Caporusso J, Harkless LB, Mills JL, Sr., Armstrong DG. Toe and flow: essential components and structure of the amputation prevention team. J Vasc Surg. Sep 2010;52(3 Suppl):23S-27S.
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Dr. Julian L. Seifter, 61, a nephrologist at Brigham and Women’s Hospital in Boston and a Harvard Medical School professor, specializes in treating patients who have chronic kidney disease.
We spoke at his Harvard office for three hours about his new book, “After the Diagnosis: Transcending Chronic Illness,” which was written with his wife, Betsy Seifter. It’s about living with diabetes, heart disease, lupus, even AIDS. An edited version of that conversation and subsequent e-mails follows.
Q. You are a doctor who treats people with chronic diseases. But you have one — diabetes. Are you a good patient?
A. Mixed. When I was diagnosed — 30 years ago — my first response was to run away from the illness. I was just at the beginning of my career, I had a young family and I didn’t want to be held back by my metabolic problems. Yes, I took insulin. But staying on a restrictive diet and monitoring my blood sugar levels was harder. I pretended to myself and others that I wasn’t sick.
I’ve had complications associated with three decades of diabetes — an eye hemorrhage, neuropathies. Over time I’ve tried for better control of my blood sugar levels, but I’ve never been perfectly successful. Good control means trying to duplicate what the pancreas does, and I never really wanted to become my pancreas.
Q. Has being a patient helped you be a doctor?
A. I’ve certainly learned things I’ve brought back to the clinic. I have a retinopathy, for instance, which can be a complication of diabetes. I don’t have good vision in my right eye, as a result. When this first happened, I said to my ophthalmologist, “I can’t lose vision. I need to read.” And he said, “Any vision is better than no vision.”
That was important. I started thinking, “Concentrate on things you still can do and develop some new things.” I’ve since started gardening, which doesn’t require the most acute vision. It’s something I probably wouldn’t have done otherwise. I counsel my patients to replace what they’ve lost with something new.
Q. Can you give an example?
A. I had one patient who was a scuba diver and who loved discovery. I had to tell him that with his condition scuba diving isn’t safe for him. So I’ve encouraged him to prospect for Native American relics in the Southwest desert, which he’s also interested in. It’s a way he can still be an explorer, but not risk his kidney.
Q. You write that a chronic disease can provide an opportunity for growth and personal development. That’s hard to imagine.
A. It can shake you out of old habits and routines. It takes away the “taken for granted.” You’re invited, almost forced, to find new directions and pursue unexplored potentials.
I had a patient, Cassandra, an opera singer, who first came to me because it was thought she had a kidney problem. It turned out she had a severe inflammatory condition in the head and neck — in the larynx, her instrument. She could no longer sing professionally. With no science background, she began reading the papers on her treatment and cultivated an interest in the illness. Eventually, she went back to college, took science courses and got accepted to medical school. She’s about to become a nephrologist.
Q. So a chronic disease diagnosis doesn’t have to be seen as The End?
A. It doesn’t have to be. Sometimes it is, though. I had another patient, a policeman, very overweight, with diabetes. He could drink a case of beer at a time. And he totally enjoyed his social life. By the time he was 60, he needed amputation and dialysis. He said, “I don’t want that.” I wasn’t going to talk him out of it. He had hospice care and he died peacefully.
If someone rejects dialysis, I want to make sure they’re not doing that because of depression. If a patient is wavering, I’ll say: “At least try it. You can always come off.” I had a patient who, at first, rejected dialysis, but who agreed to a trial and then found that the treatments made him feel so much better that he then wanted to stay on. It was a three-times-a-week commitment, but he came to see how he could fit it into his life — which he’d still have.
Q. Is it difficult to get patients to agree to a treatment as difficult as dialysis?
A. The alternative is death. I try to meet my patients wherever they are so that they will do it.
I had one who wanted to go to Florida a last time before starting dialysis. I worried about him. His condition was such that he might have heart failure. But I also knew he’d never go onto dialysis without doing this. I said, “O.K., call me when you land in Miami.” He said, “Doctor, you don’t understand, I’m driving down.”
Now, this was really dangerous. So I said, “Call me from each state and I’ll have the address of someone you can check in with in case there’s an emergency.”
The phone calls came in regularly until the last day of his trip. I was worried and I called his home in South Florida, and there was such an incredible noise in the background that I could hardly hear his wife. “What’s going on?” I asked. “That’s the rescue helicopter on the front lawn,” she said. He’d made it there, but then needed to be airlifted to the hospital!
Q. Do you regret enabling this journey?
A. No. From my own experiences, I understood why patients sometimes resist doing what’s best. The idea of sticking yourself with a needle every day for life: that wasn’t easy for me to accept. I hated the thought that every morning I was going to wake up knowing, “I have diabetes.” So I’m not a puritan with my patients. You have to do what is possible.
Q. In your book, you suggest a heretical idea: that chronic disease patients deny their situation, a little. You’d better explain.
A. They should do that, within reason. Everyone needs the opportunity to forget their disease for a while and think of other things. Otherwise, they can become their disease. So: I’m not a diabetic. I’m a doctor who has diabetes.
Of course, they should do everything that modern medicine offers. I always tell them that it is serious, but it’s not the end of all possibilities — you’re alive till you are dead. “It’s not over till it’s over.” Yogi Berra, he could have been a great clinician!
A version of this article appeared in print on November 30, 2010, on page D2 of the New York edition.
High Intensity Training versus Traditional Exercise Interventions
Intensive training (INT) for 12 wk is an effective training stimulus for improvement of cardiorespiratory fitness and glucose tolerance, but it is less effective than prolonged training for the treatment of hyperlipidemia and obesity. Furthermore and in contrast to strength training, 12 wk of INT had no impact on muscle mass or indices of skeletal health....
The purpose of this study was to determine the effectiveness of brief intense interval training as exercise intervention for promoting health and to evaluate potential benefits about common interventions, that is, prolonged exercise and strength training.
Thirty-six untrained men were divided into groups that completed 12 wk of intense interval running (INT; total training time 40 min·wk−1), prolonged running (~150 min·wk−1), and strength training (~150 min·wk−1) or continued their habitual lifestyle without participation in physical training.
The results showed that, the improvement in cardiorespiratory fitness was superior in the INT (14% ± 2% increase in V̇O2max) compared with the other two exercise interventions (7% ± 2% and 3% ± 2% increases). The blood glucose concentration 2 h after oral ingestion of 75 g of glucose was lowered to a similar extent after training in the INT (from 6.1 ± 0.6 to 5.1 ± 0.4 mM, P < 0.05) and the prolonged running group (from 5.6 ± 1.5 to 4.9 ± 1.1 mM, P < 0.05). In contrast, INT was less efficient than prolonged running for lowering the subjects' resting HR, fat percentage, and reducing the ratio between total and HDL plasma cholesterol. Furthermore, total bone mass and lean body mass remained unchanged in the INT group, whereas both these parameters were increased by the strength-training intervention.
In conclusion, INT for 12 wk is an effective training stimulus for improvement of cardiorespiratory fitness and glucose tolerance, but in relation to the treatment of hyperlipidemia and obesity, it is less effective than prolonged training. Furthermore and in contrast to strength training, 12 wk of INT had no impact on muscle mass or indices of skeletal health. The present investigation reveals that INT is an effective training stimulus for improvement of cardiorespiratory fitness and glucose tolerance, and in untrained subjects it may induce a significant reduction in systolic blood pressure. However, in relation to the treatment of hyperlipidemia and obesity, it is less effective than prolonged training, and in contrast to strength training, 12 wk of INT had no impact on muscle mass or indices of skeletal health.
In conclusion, the present study investigated various health effects of brief but very intense exercise training, and the marked improvements in cardiovascular fitness, glucose tolerance, and exercise endurance as well as the lowering of systolic blood pressure put emphasis on the potential benefits of high-intensity training and its ability to improve certain physiological health parameters. However, the intense low-volume training regimen had limitations, and for the short-term intervention period, it was less effective than prolonged training in relation to the treatment of hyperlipidemia and obesity. Furthermore, 12 wk of INT had no impact on muscle mass or leg bone mass, whereas strength training besides increasing the subjects muscle mass also provided a significant osteogenic stimulus that may have both acute and prolonged effects for musculoskeletal health.
Medicine and Science in Sports and Exercise® 2010; 42(10):1951-1958.
“Knocking Socks Off” Saves Limbs and Lives, New Diabetes Study Shows
For more information on "Knock Your Socks Off!", visit www.apma.org/diabetes.
Diabetic foot complications are the leading cause of non-traumatic, lower-limb amputation in the U.S. Remembering to ‘knock your socks off’ at every doctor’s visit will help to catch any potential lower limb complications early.
Bethesda, MD (Vocus) November 17, 2010
The number of Americans diagnosed with diabetes continues to rise toward record levels, with an estimated one in three adults predicted to have the disease by the year 2050 according to the Centers for Disease Control. Because many serious complications from diabetes present in the lower limbs, proper foot care for those with the disease is a vital step to keeping the disease in check. In fact, a new study on foot care for people with diabetes conducted by Thomson Reuters confirms that care by a podiatrist can drastically reduce the incidence of diabetes-related hospitalizations and amputations.
“During November’s Diabetes Awareness Month, it’s important to realize that simple lifestyle changes can go a long way toward staying healthy with diabetes. These include eating right, being active, monitoring blood glucose, and checking your feet daily,” said Dr. Kathleen Stone, president of the American Podiatric Medical Association (APMA). “Diabetic foot complications are the leading cause of non-traumatic, lower-limb amputation in the U.S. Remembering to ‘knock your socks off’ at every doctor’s visit will help to catch any potential lower limb complications early.”
According to preliminary results from the Thomson Reuters study, those with diabetes who received care from a podiatrist had a nearly 29 percent lower risk of lower limb amputation, and 24 percent lower risk of hospitalization, than those who did not. APMA’s “Knock Your Socks Off” campaign, running during Diabetes Awareness Month, aims to encourage everyone with diabetes and those at risk for the disease to remove their shoes and socks and inspect their feet and visit a podiatrist for a foot exam.
Feet should be checked regularly for signs and symptoms of diabetes to help prevent serious complications. Symptoms in the feet such as redness, tingling and cuts that are not healing can lead to diabetic ulcers and even possible amputation without prompt medical care.
“The Thomson Reuters study results show that just one visit to a podiatrist can drastically reduce the chance of a tragic diabetes-related amputation. There is now no question that a podiatrist must be a part of everyone’s diabetes management team,” Dr. Stone said. The APMA-sponsored study was conducted using Thomson Reuters’ MarketScan Research Databases, which house fully integrated, de-identified health-care claims data extensively used by researchers to understand health economics and outcomes. Studies based on MarketScan data have been published in more than 130 peer-reviewed articles in the past five years.
Combined Clinical and Laboratory Testing Improves Diagnostic Accuracy for Osteomyelitis in the Diabetic Foot
Adam E. Fleischer DPM, MPH1, 2, , , Adam A. Didyk DPM3, Jason B. Woods BS4, Sarah E. Burns BS4, James S. Wrobel DPM, MS5 and David G. Armstrong DPM, PhD6
1Assistant Professor of Radiology, Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science, North Chicago, IL
2Department of Surgery, Advocate Illinois Masonic Medical Center, Chicago, IL
4Podiatric Medical Student, Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science, North Chicago, IL
5Associate Professor of Medicine and Director, Scholl's Center for Lower Extremity Ambulatory Research (CLEAR), Rosalind Franklin University of Medicine and Science, North Chicago, IL
6Professor of Surgery and Director, Southern Arizona Limb Salvage Alliance (SALSA), University of Arizona College of Medicine, Tucson, AZ
Available online 13 November 2008.
The purpose of this investigation was to examine the value of using routinely available clinical and laboratory tests in combination to distinguish osteomyelitis from cellulitis in a diabetic population with mild to moderately infected forefoot ulcers. We conducted a case-control study of 54 diabetic patients with 54 locally infected ulcers admitted to a university-affiliated tertiary-care hospital over a 4.5-year period. A total of 30 clinical and laboratory characteristics obtained at admission were tested for their association with pathology-proven osteomyelitis using logistic regression techniques. Ulcer depth greater than 3 mm (univariate odds ratio 10.4, P= .001) and C-reactive protein greater than 3.2 mg/dL (univariate odds ratio 10.8, P< .001) were the most informative individual clinical and laboratory tests for differentiating osteomyelitis from cellulitis. Adding C-reactive protein also significantly improved upon the accuracy of the study's best clinical testing strategy (area under the curve improved from 0.80 to 0.88, P = .040). Strategies that combined ulcer depth with serum inflammatory markers proved most useful in detecting ulcerated patients with concomitant bone infections (sensitivity 100% [95% CI 89.7%–100%] for both ulcer depth greater than 3 mm or C-reactive protein greater than 3.2 mg/dL, and ulcer depth greater than 3 mm or erythrocyte sedimentation rate greater than 60 mm/h). We conclude that considering clinical and laboratory findings together can significantly improve our diagnostic accuracy for osteomyelitis in the diabetic foot. The specific combination of ulcer depth with serum inflammatory markers appears to be a particularly sensitive strategy that may allow for greater detection of early diabetic osteomyelitis. Level of Clinical Evidence: 3
Key Words: C-reactive protein; case control study; diabetic foot infection; diagnosis; erythrocyte sedimentation rate; osteomyelitis; ulcer
Osteomyelitis (OM) that results from diabetic foot ulcers (DFUs) continues to be a costly health problem worldwide. The prevalence of foot ulcers among persons with diabetes is estimated to be 4% to 10%, and the lifetime incidence of developing a DFU may be as high as 25% ([1] and [2]). Underlying bone infections will accompany 20% to 68% of infected DFUs ([3], [4] and [5]), and the presence of OM greatly increases the likelihood for lower extremity amputation (6). The economic burden of caring for DFUs that go on to amputation is substantial, with direct costs alone exceeding $34,000 (US) per event (7).
Increasing evidence now suggests OM of the foot can be successfully managed without extensive surgery ([8], [9], [10], [11], [12] and [13]), still many individuals are discovered late when amputation is the only viable option. This is due, in part, to the admittedly poor clinical sensitivity (0% to 54%) for recognizing early bone involvement ([4], [14], [15] and [16]). Standard radiographs are also not very discriminating, and may miss up to half of diabetic patients presenting with underlying OM (17). Individual clinical and laboratory tests for OM ([4], [18], [19], [20]and [21]) appear to lack the sensitivity and accuracy required of an early detection marker; however, the diagnostic utility of employing a combination of findings is still unknown ([17], [22] and [23]). In this article, we describe the results of a case-control study, wherein we examined the combined value of routinely available clinical and laboratory tests used to diagnose OM in a diabetic population with mild to moderately infected forefoot ulcers. We wanted to determine if one or more simple testing strategies could display the favorable attributes that might be expected of an early detection marker.
Patients and Methods
Source Population
This analysis was performed at a 550-bed university-affiliated tertiary-care hospital, which also serves as a level-I trauma center for the greater Chicago area. Any diabetic patient admitted from January 2002 to June 2006 with a single forefoot ulceration (eg, toes or metatarsal heads) and concomitant Infectious Diseases Society of America—International Working Group on the Diabetic Foot (IDSA-IWGDF) grade 2 (mild) or 3 (moderate) foot infection was eligible (24). Included subjects were selected on their ability to satisfy strict case or control definitions outlined below and without any knowledge of potential explanatory variables. Patients with multiple ulcerations, primarily ischemic ulcerations, nonhealed recent surgical wounds, or with limb-threatening (IDSA-IWGDF grade 4) infections were not included. Patients with conditions known to alter erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) levels, such as active cardiac disease, uncontrolled rheumatologic disease, or another known active infection, were excluded. The study protocol was reviewed and approved by the local ethics committee, and the requirement for patient consent was waived.
Definition of Cases and Controls
Case patients were defined as ulcerated patients with histopathology-proven OM of the underlying bone during the first 10 days of admission. Bone specimens were obtained by percutaneous biopsy or open surgical debridement. All case patients had bone specimens showing focal necrosis, intramedullary fibrosis with infiltration of mature neutrophils, and received a formal pathology diagnosis of “acute osteomyelitis.” Because we were interested only in examining predictors of earlybone infection, those patients with histological evidence of chronic OM alone were not included in the analysis. Controls were sampled from the same source population as index cases. Cellulitis only status was conferred when bone specimens failed to show any characteristics of OM (n = 2), or when patients had a negative technetium 99m scan (99mTc), leukocyte scan, or magnetic resonance image (MRI) and required only abbreviated (≤3 weeks) antibiotic therapy for resolution of their foot infection, without recurrence of infection at the same or adjacent site for at least 12 months (n = 18).
Definitions Used for Explanatory Variables
Information for explanatory variables was obtained from the first day of admission. Clinical indicators (variables derived from history taking and physical examination) and laboratory tests selected for review were based on the work of previous investigators ([4], [18], [19], [20], [21] and [25]). We defined peripheral arterial disease as an ankle brachial index less than 0.8 or when patients did not have a palpable pedal pulse on clinical exam. All ulcer measurements were obtained following the initial bedside debridement. Given the retrospective nature of the study with several different observers charting the clinical information, we chose to record ulcer depth categorically as either “deep” (>3 mm) or “shallow” (≤3 mm) (4). All ulcers with exposed bone were automatically considered “deep” regardless of measured depth (4). ESR and CRP values were obtained by means of the modified Westergren method (26) and the heterogeneous sandwich immunoassay method (27) respectively.
Statistical Analysis
Patients with missing data for one or more explanatory variables were dropped from the analysis (n = 6). This allowed for 54 evaluable subjects. Continuous variables were initially examined using Student t-test or Wilcoxon rank-sum test, then stratified into normal and abnormal categories. Additional cutoff levels for continuous predictors were determined through receiver operating characteristic (ROC) analysis and tested accordingly. Dichotomous predictors were examined using Fisher's exact test, and logistic regression models were used to obtain odds ratios (OR) for univariate estimates. A 2-step multiple logistic regression analysis was used to determine the specific clinical and laboratory contributions to the prediction of OM. First, stepwise regression using P ≤ .05 for inclusion and P > .05 for exclusion was performed to determine the best “clinical indicators” only model. Then, similar to everyday practice where additional laboratory tests are performed after clinical information has been acquired, the analysis was repeated by adding the study's full compliment of dichotomous laboratory tests while retaining all previously identified clinical indicators. Separate models were tested for highly correlated predictor variables. Potentially relevant interaction terms were included in the models but removed again if they did not contribute to the diagnostic accuracy. Final “clinical” and “clinical plus laboratory” models with the greatest areas under the curve (AUC) were then compared with each other using the DeLong equality test (28). Still further, sensitivities, specificities, positive and negative likelihood ratios (LR), and post-test probabilities (PTP) were calculated for all individual predictors and their pairwise combinations. Accuracies for dichotomous tests were calculated using 2 × 2 contingency tables, where accuracy = [(a + d)/total] × 100. The analysis was carried out using SAS System for Windows, version 9.1 (SAS Institute, Cary, NC, and Microsoft Corporation, Redmond, WA). All of the tests were 2-tailed with Pvalues of .05 or less considered to be statistically significant.
Results
During the 4.5-year study period, there were 34 evaluable case patients, and 20 controls with cellulitis only. The average age of the population was 61.5 (range 27 to 90) years, and most of the subjects were men (44/54, 81%). Most patients had type 2 diabetes (51/54, 94%) for greater than 10 years (44/54, 81%), and 6% (3/54) were receiving hemodialysis regularly. All 54 patients had sensory neuropathy as determined by the absence of appreciation of the 10-gram monofilament upon touch-pressure testing. The average DFU duration prior to admission was 24.6 ± 44.9 days, and the mean ulcer area was 2.25 ± 1.8 cm2. Slightly more than half of all wounds occurred in the toes (29/54, 54%), and fewer than 10% (5/54) were deep enough to expose bone. On average, patients with OM had higher CRP and ESR levels compared with those without OM (10.3 versus 4.6 mg/dL, P = .006, and 85.4 versus 52.6 mm/h, P = .008, respectively). Patients with OM also had higher white blood cell (WBC) counts than those with cellulitis only (mean: 10.5 versus 8.0 × 103/μL, P = .043).
Results from the univariate analysis are summarized in Table 1, with association expressed in terms of odds ratios (ORs). Being able to probe a wound to bone (OR 5.0, P = .024) or having a deep (> 3mm) ulcer (OR 10.4, P = .001) were important individual risk factors for underlying OM. Not surprisingly, every wound with exposed bone was also found to have concomitant OM (5/5). WBC counts higher than 11.0 × 103/μL (OR 6.3, P = .025) and a neutrophil percentage greater than 70% (OR 3.8, P= .032) were also useful laboratory markers for OM, while a larger ulcer area (≥2 cm2) was protective against OM (OR 0.20, P = .014). Serum inflammatory markers proved to be important predictors of OM at multiple cutoff levels, but ESR greater than 80 mm/h (OR 16.8, P = .009) and CRP greater than 3.2 mg/dL (OR 10.8, P < .001) demonstrated the highest diagnostic ORs in the univariate analysis.
TABLE 1.
Individual predictors of underlying osteomyelitis: univariate analysis (N = 54)
Cutoff levels for continuous variables refer to normal/abnormal or historically important categories, except in the case of alkaline phosphatase, erythrocyte sedimentation rate, and C-reactive protein which represent important cutoffs determined through ROC analysis.
OM, osteomyelitis; MTH, metatarsal head; ABI, ankle-brachial index; HbA1c, hemoglobin A1c; WBC, white blood cell.
Indicates logit estimator (0.5 correction) was used for zero cells.
Table 2 summarizes the results from the staged multivariate analysis. When first considering just clinical findings, only 2 predictors for OM emerged once the effects of other clinical covariates were adjusted for—temperature higher than 37.2°C (99.0°F) and ulcer depth greater than 3 mm (CI, “clinical indicators” model, AUC 0.80). As expected, many laboratory variables were highly correlated with each other. ESR and CRP, however, showed the strongest association (r = 0.508, P < .0001) and were therefore treated in separate models during the model-building process. When important CRP or ESR cutoff values were considered along with ulcer depth and body temperature, no other laboratory test demonstrated significance in the second stage of the multivariate analysis. Furthermore, adding either CRP or ESR to the study's best “clinical indicators” model always resulted in a nonsignificant OR for temperature greater than 37.2°C. In the end, a “clinical indicators + CRP 3.2” model (AUC 0.88) and “clinical indicators + ESR 60” model (AUC 0.88) achieved the greatest accuracies of any of the diagnostic models examined in the study.
TABLE 2.
Significant predictors of underlying osteomyelitis: multivariate analysis (N = 54)
The ROC curves for the study's best “clinical” and “clinical plus laboratory” predictor models are provided in Figure 1. Here, we see that a “clinical indicators + CRP 3.2” model predicted the probability of OM significantly better than the “clinical indicators” model alone (P = .040). The addition of ESR 60 mm/h also improved upon the diagnostic accuracy of the study's best “clinical indicators” model, but this change fell short of achieving statistical significance (P = .055). Neither a “clinical indicators + ESR 60” model or a “clinical indicators + CRP 3.2” model demonstrated any obvious superiority over the other (P = .930).
FIGURE 1. ROC curves of the final 3 predictor models for diagnosing underlying osteomyelitis. Areas under the curve (AUCs) were tested mutually for significance using the DeLong (28) equality test. CI, clinical indicators (temperature >37.2°C + ulcer depth >3 mm).
Additional performance characteristics for several individual and combined testing strategies are given in Table 3. CRP greater than 3.2 mg/dL was the study's most sensitive individual test for OM (sensitivity 85% [95% confidence interval: 73%–97%]) with the most influential negative likelihood ratio (LR) value (−LR 0.23). Using our study population with a set prevalence (hence, prior probability) of underlying OM of 63%, a CRP level less than or equal to 3.2 mg/dL lowered ones PTP for the disease to just 28%—the largest drop among any of the individual tests. However, the finding that was most indicative of OM when positive was an ulcer depth greater than 3 mm (+LR 4.3), which increased the PTP for OM in our sample to 88%. CRP was the study's most accurate single test, correctly identifying 78% (42/54) of the subjects with respect to disease status using a cutoff of 3.2 mg/dL. Ulcer depth greater than 3 mm was the second-most accurate individual test and correctly classified 72% (39/54) of the patients.
TABLE 3.
Test characteristics of select strategies for underlying osteomyelitis: ranked by increasing sensitivity (N = 54)
+LR, positive likelihood ratio; −LR, negative likelihood ratio; +PTP, positive post-test probability (%); −PTP, negative post-test probability (%); WBC, white blood cell; ESR, erythrocyte sedimentation rate; CRP, C-reactive protein.
63% refers to the prevalence of osteomyelitis in the current study, which is similar to other inpatient samples (19). † 20% refers to the prevalence of osteomyelitis observed by Lavery et al (3) among outpatients with infected diabetic foot ulcers. ‡ 0.5 correction was used for zero cells.
Considering clinical and laboratory tests together generally allowed for substantial increases in both sensitivity and accuracy, with only modest (10% to 15%) declines in specificity. For example, by combining the study's most informative clinical indicator, namely ulcer depth greater than 3 mm, with the most informative lab test, namely CRP greater than 3.2 mg/dL, a testing strategy with 100% (95% confidence interval [95% CI] 89.7%–100%) net sensitivity and 55% (95% CI 33.2%–76.8%) net specificity could be created. The strategy improved the rate of OM detection by 55% (1/0.647), but came at the price of tripling the likelihood of obtaining a false-positive result compared to using ulcer depth alone (0.166 versus 0.055). Still, the strategy correctly identified disease status for more patients (45/54, 83%) than did either test when used alone. A positive test (defined as having an ulcer depth >3 mm or CRP >3.2 mg/dL) increased the probability for underlying OM from 63% to 79%, while having a negative test (ulcer depth ≤3 mm and CRP ≤3.2 mg/dL) essentially ruled out the possibility of OM (−PTP 1.5%).
Similarly, a strategy that combined ESR greater than 60 mm/h with ulcer depth greater than 3 mm had 100% (95% CI 89.7%–100%) net sensitivity and 60% (95% CI 38.5%–81.5%) net specificity for OM, again improving the rate of case detection by 55% (1/0.647) while increasing the rate of obtaining a false positive by 2.7 times (0.148 versus 0.055). This combination accurately identified the largest number of subjects (46/54, 85%) with respect to disease status. A positive test increased the probability for underlying OM to 81%, while a negative test again nearly ruled out the possibility of concomitant bone infection (−PTP 1.3%).
Discussion
Similar to previous investigations, our results echo the importance of ulcer depth as a marker for underlying OM in patients with diabetes ([4], [22], [23] and [29]). In our study, patients with infected forefoot ulcers greater than 3 mm deep, or those with exposed bone, were at least 10 times more likely to have concomitant OM than those with shallow ulcers. Ulcer depth was also the only significant clinical predictor of OM once laboratory tests were factored in to the decision-making process. In contrast, other accepted clinical risk factors like ulcer area greater than 2 cm2 (4) and probing to bone (19), failed to contribute any additional diagnostic information beyond that of ulcer depth and body temperature in our sample of nontoxic patients. In fact, we actually found a protective effect with increasing ulcer size. This discrepancy with previous reports may be partly explained by that fact that all of the patients in our study were hospitalized whereas most (68%) of the wound characteristics described by Newman and colleagues (4) were observed in outpatients. We also excluded patients with a foot abscess or limb-threatening cellulitis, and in so doing, may have inadvertently “selected for” those cellulitic inpatients with wounds with the largest total surface areas.
An original and important observation that emerges in this analysis is that the diagnostic value of ulcer depth could be enhanced when considered in conjunction with serum inflammatory markers. Adding CRP or ESR to ulcer depth increased the rate of OM case detection by 55% compared to using ulcer depth alone, and both of these combined testing strategies allowed everyone in the study with underlying OM to be identified—achieving 100% sensitivity. Despite producing a greater number of false positives, the addition of CRP and ESR still resulted in more accurate dichotomous and multivariate testing strategies compared to using the same strategies without these markers. Furthermore, ESR and CRP trumped all of the other laboratory tests for underlying OM, rendering individual predictors like leukocytosis and an elevated percentage of circulating neutrophils nonsignificant in the multivariate analysis. Taken together, these findings clearly indicated that CRP and ESR levels are valuable additions during the initial workup for OM in nontoxic diabetic patients.
Finally, we also found that, when used alone, CRP was still particularly useful in predicting the presence of diabetic OM. This may not be that surprising since elevated CRP levels are more common among diabetic patients with foot ulcers than in those without ulcers (25), and even higher levels of circulating CRP can be found in patients with infected DFUs versus those with noninfected DFUs (30). CRP is also a recognized diagnostic aid in other types of musculoskeletal infections ([31]and [32]). What we found striking, however, was that CRP outperformed all of the other individual clinical and laboratory tests used to diagnose OM in the study—including ESR, probe-to-bone, and ulcer depth. This value of CRP for diagnosing diabetic OM has not been previously demonstrated. Using a cutoff level of 3.2 mg/dL, CRP was our most sensitive and accurate single marker for OM, and identified an impressive 85% of the subjects with underlying bone involvement. Based on this, rapid CRP testing could assume a heightened role in primary care and other nonspecialty settings where ulcer characteristics like wound depth will many times not be appreciated for days as patients wait to be seen for ulcer debridement by the appropriate consultant.
This analysis was limited by its retrospective study design. Data for newer potential OM biomarkers like procalcitonin ([30] and [33]) were not available for inclusion. Moreover, using an inpatient population, it is uncertain how well our observations may translate to unsuspecting community patients. We were however careful to restrict the analysis to subjects with localized mild or moderate foot infections, which should make the findings slightly more generalizable to an ambulatory population. For example, patients with severe infections, abscesses, or advanced bone infections such as chronic OM, who typically require surgery as part of their definitive therapy, were not included. Still we recognize, some of the patients may have had occult inflammatory processes, unrelated to foot infection, which could have influenced our results. Last, we did not undertake a sensitivity analysis to assess the resistance of our results to the potential influence of an unmeasured variable that could have confounded our results.
In conclusion, contiguous OM of the foot is an ominous precursor to amputation for many patients living with diabetes. Although prompt recognition may help curtail the need for ablative surgery ([8], [9], [10], [11], [12] and [13]), early detection has remained elusive without a reliable and rapidly available test for the disease. Our study provides evidence that combining basic clinical and laboratory findings can improve our diagnostic accuracy and sensitivity for underlying OM in the diabetic foot. Patients presenting with an infected forefoot ulcer measuring more than 3 mm deep or extending to bone, or those with extreme elevations in one or more serum inflammatory markers, namely ESR greater than 60 mm/h or CRP greater than 3.2 mg/dL, should be quickly recognized as having an increased likelihood of underlying OM. Conversely, those with shallow ulcers and only mild to moderate elevations of their serum inflammatory markers will most likely have infections that remain confined to the soft tissues. Developing simple testing strategies or rules like this may help to reduce the rate of amputation by identifying greater numbers of unsuspecting patients who could benefit from formal diagnostic testing, such as magnetic resonance imaging or bone biopsy, earlier in the disease process (17). Prospective external validation of these findings will of course be necessary.
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Jeffrey Siegel, DPM, FACFAS, DABPO Adjunct Assistant Professor, Depts. Of Medicine and Surgery, TUSPM
Impression:
Abscess with probable cuboid Osteomyelitis.
Severe right foot deformity, secondary to Acute Chronic Charcot Neuroarthropathy.
Convex calcaneal valgus deformity w/Equinus.
Diabetes mellitus, Type II w/peripheral neuropathy manifestations, unknown control.
Hypothyroidism, stable
Anemia, stable
Cardiac arrhythmias, stable
Acute and Chronic Charcot Neuroarthropathy
Plan: I had a very long discussion with Mrs. B and her husband regarding the progression and natural history of her particular Charcot foot deformity. We discussed at length that when all is said and done, she could still lose her leg. She reiterated that she doesn't want a primary leg amputation and is willing to do what ever it takes to at least try to save her leg. "If I can survive WW II, I can survive this!" "Let's get to it!" With that, I recommended hospital admission today, Jones compression dressing, rest and elevation while we wait for medical and cardiology clearance and a trip to the OR tomorrow. Since she is afebrile and not septic, a decision to withhold antibiotics until bone cultures could be obtained was made by ID.
Admission labs were as follows: WBC-8.2, RBC-3.35, H/H-9.8 gm/30%, PLTS-515 DIFF: PMN-77/LYMPH-13.3/MONOS-1.9 COAG: PT/PTINR-14.5/1.27 PTT-36.8 ESR- 50mm
Cultures: Blood: NG after 72 hrs Aerobic/Anaerobic/ AFB and Fungal Cultures (in office seroma aspirate) - MSSA Bone biopsy cuboid and culture - Acute Osteomyelitis/MSSA. Etiology: extension from dorsal seroma.
Surgical Plan: Patient was taken to the OR for phase one of her limb salvage process: debridement of cuboid w/Bone Bx and Culture, a 6L wash-out and placement of Vancomycin and Gentamycin impregnated PMMA beads. IV Zosyn and vancomycin were then started intra-operatively by the anesthesiologist. The lower extremity was then re-draped, gowns and gloves were changed and new instruments were used for the following procedures: Achilles tendon percutaneous lengthening and percutaneous placement of an Ilizarov circular frame.
Next, the tibial block (Figure 9) was placed on her leg followed by completion of a percutaneous TAL (Figure 10). The next step in patient's Ilizarov frame construction was placement of the calcaneal half ring. The stability of this part of the frame is very important as it will serve as a base for the forefoot half-ring to push off of. The forefoot half ring is placed perpendicular to the deformity just distal to the Center of Rotational angulation (C.O.R.A.). The ring is connected to the tibial block by a hinged connector (Figure 11)
The final component will be attaching medial and lateral 6 inch threaded rods. This will allow gradual distraction and lengthening of the soft-tissues which will ultimately facilitate manipulation and closed reduction of the C.O.R.A. and placement of the beam fixation planned in stage two.
Because of profound neuropathy, the distraction process in Charcot patients can be accelerated at a rate of 2-3 mm per day (Figure 12).
Notice the bending of the threaded rods as they distract and stretch the soft-tissues. Skin and vascular status were monitored daily during the distraction period. Rubber stoppers are used to hold silver impregnated dressing sponges in place during the 8-10 week partial-weight bearing fixation period. Radiographs confirmed placement of the PMMA beads and the distraction at Lisfranc's joint (Figure 13,14).
Mrs. B received a one time dose of Aredia 90mg, used calcitonin nasal spray BID during her convalescence and takes Vit. D3 and Calcium 1gm daily.
Phase two of the limb salvage process involved removal of the fixator, all but three of the PMMA beads (kept in as a spacer) and manipulation of the foot into a plantigrade position (Figure 15,16).
Once in place, percutaneous placements of cannulated 80-100mm intramedullary beam screws were inserted in the midfoot. The midtarsal joint was rigid and it was impossible to manipulate the hindfoot in-line with Lisfranc's joint. (Figure 17,18). A short leg fiberglass cast was worn for 3 weeks, a CROW walker was used for 3 months and a custom molded shoe with double upright brace will be worn for a year and the braces will be removed. Clinically, her foot has a slight skewfoot appearance but in a rectus position (Figure 19, 20) and her gait is stable (See video gait).
Discussion:
Charcot Neuroarthropathy represents one for the greatest risk for lower extremity amputation that challenges our diabetic patients. Non-weight bearing is the only known cure and traditional treatments have consisted of immobilization of the leg regardless of the severity of the fracture/dislocation "as is" and strict NWB. Once the acute edema and erythema of E1 (Eichenholtz stage 1) resolve, they are placed into a CROW or TCC for three months until stage E2 and then into a custom molded shoe (E2/3). When plantar wounds developed, and months of wound care and off-loading failed, an exostectomy was performed. Twenty years ago when I was a resident, that was as aggressive as it got. Fast forwarding to today, we spend hours training our residents to perform complex 5 hour reconstructive arthrodesing procedures with or without a rotational flap. Our procedures are not always successful. With big procedures come big problems: wound dehiscence, infection and amputation - the one end result we were trying to prevent in the first place. Or in two years the patient dies, not due to the surgery, but don't forget these people are sick, despite obtaining medical clearance with their >5 co-morbidities. Need I forget to mention the hundreds of hours of worry, lost sleep, significant lack of fair reimbursements and the excessive exposure of your practice to litigation. So why do I do this? So when is enough, enough? This was the question posed by Dr. Shapiro that he addressed in a previous article and provided the motivation to write this case study.
What we can do is offer bonafied hope to a select number of patients when all their score cards read zero in an attempt to save their leg. This, in the world of the Podiatric foot and ankle surgeon, is everything. And that is why I do this type of work....and I know I am not alone!
Unfortunately, we have "many" obstacles that wage battle with our altruistic goals: patient and family compliance, obesity, retinopathy, neuropathy, psychosis, economics, nutrition/glucose control, upper body strength, balance, home environment, etc. etc. So, when patients are told point blank that "you need an amputation", some of these patients accept their fate, while others manage to find their way to your office for hope. It is critical that Podiatric foot and ankle surgeons are completely transparent with the patient and family regarding the fact that "high risk surgery can lead to high risk complications" and home life with a "cage". In my practice, these are the patients who share with me, "I hear what you are saying, BUT if there is even a 10% chance of saving my leg, please try." What would you do in their situation ?
Let Us Consider the Decision for Mr. B
That brings us to our case study: Mrs. B. is a 78 y/o grandmother who presented with a midfoot Charcot deformity, dorsal foot abscess/seroma with secondary cuboid osteomyelitis, doomed for amputation. Traditional medicine would have us debride the cuboid, wash out, place antibiotic beads or fashion an antibiotic cuboid spacer, IV antibiotics for 6 weeks, and immobilization. If after negative bone biopsy, cultures and normalization of the CRP, we either take her back to the OR, harvest bone from her hip, create two long incisions for an arthrodesis, and start 3-4 months NWB OR just leave it alone and wait for the recurrent midfoot ulceration and probable amputation.
Mrs. B. is 78 years old! I recommended another option: closed reduction with external fixation (CREF) and gradual distraction, while simultaneously addressing the osteomyelitis. The frame was not pre-assembled. While this procedure complies with the traditional paradigm, CREF w/gradual distraction is best indicated for patients in the acute/semi-acute Charcot setting. In sedentary or elderly patients, this modality can accurately address the deformity withoutincisions and still yield a stable, deformity-free rectus foot. If there are open wounds or bone infection as in this patient, the frame can be custom built to avoid the problem areas, allow placement of a VAC in case of wounds and still aggressively treat the deformity. Once edema and erythema (E1) resolve, partial weight bearing can be instituted. So, rather than accepting the deformity "as is", CREF can correct the problem while respecting the soft-tissue and osseous structures need to rest, heal and consolidate (beginning of E2). Three weeks following the beaming (now into Stage E2), patients are then placed in their CROW in the same timeframe as with traditional approaches to Charcot treatment.
In stage two, the frame was removed, the deformity manually reduced and IM beams percutaneously placed through the 1st and 2nd TMT joints. The midtarsal joint was rigid and not reducible so the hindfoot was not beamed. There was no cuboid so the lateral column was not beamed. Plus, although her labs documented resolution of her bone infection and her foot was clinically stable (no edema, erythema and normalization of skin temperature), I had serious concerns regarding the existence of walled-off pockets of chronic osteomyelitis and did not want to place hardware in the area. I also was concerned regarding instability, so Mrs. B agreed never to walk barefoot (except for the video).
No matter how we treat our Charcot patients, the ultimate goals are to provide a stable, plantigrade foot, remove as much of the deformity as possible so that the extremity can be braced. In select patients, when CREF with distraction is followed by a beaming procedure, the gap between accepting the deformed foot "as-is" and do nothing vs. major reconstructive surgery and months of non-weight bearing can be bridged with much less risk.
###
Commentary by Robert Frykberg, DPM, MPH & PRESENT Podiatry Editor, Limb Salvage:
I applaud Dr Siegel for his efforts to think "out of the box" to address this lady's concerns regarding a very serious, although rare complication of diabetes. The Diabetic Charcot Foot is indeed a clinical conundrum that most podiatric physicians have to manage on a fairly frequent basis. It is indeed a potentially limb-threatening complication, especially in cases further complicated by recurrent foot ulcerations. There is literally an explosion of new literature in the podiatric, surgical, and medical disciplines concerning this entity in terms of underlying pathophysiology, diagnosis, and management. While once considered "taboo", surgical management of the Charcot foot has become progressively more commonplace over the last two decades. We frequently see case series or case reports of sometimes novel approaches to the operative reconstruction of neuropathic foot deformities. While certainly not novel, this case adds another to a long list of case reports in the literature. Nonetheless, we have few randomized controlled trials to guide us in this regard (only for medical or non-surgical treatments) and several prospective case series (cohort studies involving single cohorts of surgical patients). Hence, most of our decisions are based on retrospective cohort studies, case series, or case reports.
This begs a long series of questions that I know Dr. Siegel asked himself before granting this patients request for operative treatment, and I, as devil's advocate and educator, must bring to your attention "What is the long term benefit of our approach and are we improving the patient's quality of life by operating on them"? Was this patient's limb truly "at risk" when the surgery was performed? How do we know that this patient (or any other for that matter) is better served by operative intervention or by conservative management? Where is the evidence to substantiate our position? Where are the comparative effectiveness trials to ascertain which patients (and deformities) are best served by surgery and which are best treated conservatively? Knowing full well that neuropathy and external fixation impart an independent 4-fold and 3-fold risk for postoperative infection (Wukich et al. 2010), should we not take this into consideration when deciding to operate on such complicated patients? Would we do a complex flatfoot reconstruction on a healthy 78 year old woman? When is enough surgery enough?
This woman had her deformity for 6 months preoperatively, but is relegated to at least 1.5 years of surgical recuperation before she can ambulate without braces (provided no complications ensue). How do we know that a CROW brace and subsequent molded show would not suffice in the long term for her? She seemed to have a plantigrade foot without plantar ulcerations at the time of presentation. Has the surgery made her better off in the long run? (We do not have a long term follow up at this point) Will she survive long enough to regain her independent mobility? Has her osteomyelitis been "cured"? Everything is wonderful when the surgery works out well, but I worry about potential complications (i.e., MI, DVT, PE, Pin Tract infections, Osteomyelitis, etc.). Hence the need for evidence to support our approach to patients, both in general and at the patient level.
Surgical approaches to the Charcot foot have indeed corrected thousands of deformities and saved many limbs from amputation to be sure. This is a good thing. New approaches need to be considered, but carefully considered based on specific patient characteristics and surgical criteria (much of which is currently lacking). So the question as to when or when not to operate looms before us all. Is this a condition looking for a surgical technique or do we have techniques looking to be applied to this condition? The answer will always fall back on the premise that we do what is best for the patient in the given circumstances. Caution should rule the day with these very complicated patients - often with underlying cardiac dysfunction, autonomic neuropathy, morbid obesity, and renal insufficiency. But we must face the realities of our current predicament: there is little high level comparative evidence to support our positions. Damned if we do and damned if we don't.
I hope this editorializing will not discourage the reader from entertaining surgical options for the Charcot foot- it is meant to serve as a reminder of the complexity of not only the patients, but also of some of our procedures. And primarily, we are looking to generate discussions on this very difficult subject. I expect many of you to disagree with me, while many more seasoned practitioners might very well have the same precautionary approach that I advocate. An eTalk discussion has already begun on the PRESENT Podiatry website. Let's talk about it and learn from each other's experiences !
As many as 1 in 3 U.S. adults could have diabetes by 2050 if current trends continue, according to a new analysis from the Centers for Disease Control and Prevention. One in 10 U.S. adults has diabetes now. The prevalence is expected to rise sharply over the next 40 years due to an aging population more likely to develop Type 2 diabetes, increases in minority groups that are at high risk for Type 2 diabetes, and people with diabetes living longer, according to CDC projections published in the journal Population Health Metrics. Because the study factored in aging, minority populations and lifespan, the projections are higher than previous estimates.
The report predicts that the number of new diabetes cases each year will increase from 8per 1,000 people in 2008, to 15 per 1,000 in 2050. The report estimates that the number of Americans with diabetes will range from 1 in 3 to 1 in 5 by 2050. That range reflects differing assumptions about how many people will develop diabetes, and how long they will live after developing the disease.
"These are alarming numbers that show how critical it is to change the course of Type 2 diabetes," said Ann Albright, PhD. RD, director of CDC's Division of Diabetes Translation. "Successful programs to improve lifestyle choices on healthy eating and physical activity must be made more widely available, because the stakes are too high and the personal toll too devastating to fail." Proper diet and physical activity can reduce the risk of diabetes and help to control the condition in people withdiabetes. Effective prevention programs directed at groups at high risk of Type 2 diabetes can considerably reduce future increases in diabetes prevalence, but will not eliminate them, the report says.
The projection that one-third of all U.S. adults will have diabetes by 2050 assumes that recent increases in new cases of diabetes will continue and people with diabetes will also live longer, which adds to the total number of people with the disease.
Projected increases in U.S. diabetes prevalence also reflect the growth in the disease internationally. An estimated 285 million people worldwide had diabetes in 2010, according to the International Diabetes Federation. The federation predicts as many as 438 million will have diabetes by 2030.
Risk factors for Type 2 diabetes include older age, obesity, family history, having diabetes while pregnant, a sedentary lifestyle and race/ethnicity. Groups at higher risk for the disease are African-Americans, Hispanics, American Indians/Alaska Natives, and some Asian-Americans and Pacific Islanders.
CDC and its partners are working on a variety of initiatives to prevent Type 2 diabetes and to reduce itscomplications. CDC's National Diabetes Prevention Program, which launched in April, is designed to bring evidence-based programs for preventing Type 2 diabetes to communities. The program supports establishing a network of lifestyle intervention programs for overweight or obese people at high risk of developing Type 2 diabetes. These interventions emphasize dietary changes, coping skills and group support to help participants lose 5 percent to 7 percent of their body weight and get at least 150 minutes per week of moderate physical activity. The program is working with 28 sites across the United States offering group lifestyle interventions with plans to expand to additional sites in the future.
The Diabetes Prevention Program clinical trial, led by the National Institutes of Health, has shown that those measures can reduce the risk of developing Type 2 diabetes by 58 percent in people at higher risk of the disease.
Diabetes was the seventh leading cause of death in 2007, and is the leading cause of new cases of blindness among adults under age 75, kidney failure, and non-accident/injury leg and foot amputations among adults.
People with diagnosed diabetes have medical costs that are more than twice that of those without th
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Diabetes is a major non-communicable disease worldwide. There are now some 40 million people with diabetes – and a similar number with impaired fasting glucose or impaired glucose tolerance – in mainland China alone (China News, 2008). Among those with diabetes, diabetic foot disease is becoming a serious health burden, impacting negatively both on peoples’ quality of life and on healthcare budgets.
First, artificial intelligence trumped expert chess players at their own game. Then came Watson, a computer system that famously beat Jeopardy! champions Brad Rutter and Ken Jennings. Now, researchers are putting artificial intelligence to work to automate biological research—-specifically the reverse engineering of metabolic networks from experimental data.
This this video from a couple of years ago explains how the Eureqa software derived the fundamental equations of motion from observations of a double pendulum.
For 100 years, the process of vascular anastomosis has largely been the same. Surgeons take a needle and thread and delicately suture together the walls of the blood vessel. Though literally sewing together blood vessels is a widely utilized surgical procedure, it isn’t without its issues. Intimal hyperplasia, a cell response to the trauma of the needle and thread, causes blood vessels to narrow which increases the risk of a blood clot or localized turbulence. Sutures may trigger an immune response that causes dangerous inflammation. Moreover, suturing becomes extremely challenging on blood vessels that are less than one millimeter in diameter.
To accomplish this, the scientists merged human skin cells with spider silk harvested from transgenic goats. In tests, the skin proved to be strong enough to stop a .22 caliber bullet fired at a reduced speed. It didn’t succeed, however, in repelling a bullet fired at full speed. Despite that setback, such skin could eventually be used for an array of medical applications, including burn and wound treatment, and tendon and ligament repair.
Part of the problem with such tailoring is that only recently has research begun to describe the relationship between biomechanics and diabetic neuropathy.
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Diabetic foot complications are the leading cause of non-traumatic, lower-limb amputation in the U.S. Remembering to ‘knock your socks off’ at every doctor’s visit will help to catch any potential lower limb complications early.
Indicates logit estimator (0.5 correction) was used for zero cells.
+ ESR 80
CI refers to clinical indicators model.
63% refers to the prevalence of osteomyelitis in the current study, which is similar to other inpatient samples (
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