Foot ulceration remains one of the most consequential complications of diabetes. Bus and van Netten have argued that a large majority of diabetic foot ulcers are preventable, yet recurrence after healing is common and most ulcers develop at sites of repetitive mechanical loading that a person with neuropathy cannot feel. Wearable sensors that measure pressure inside the shoe and alert the wearer are an attempt to replace the missing protective sensation. This article reviews what published research currently supports.
Why Plantar Pressure Matters in Neuropathy
Loss of protective sensation allows repetitive, moderate pressure to continue unnoticed, leading to tissue breakdown beneath calluses and bony prominences. Standard prevention relies on periodic clinic visits, therapeutic footwear, and daily self-inspection. The 2023 IWGDF guidance on ulcer prevention, led by Bus and colleagues, recommends a package of measures for people at high risk: education, regular foot examination, appropriate footwear, and treatment of pre-ulcerative signs. Between visits, however, clinicians have little insight into how a patient’s feet are loaded during everyday walking.
The Intelligent Insole Trial
The most cited randomized evidence comes from Abbott and colleagues (The Lancet Digital Health, 2019). In this proof-of-concept study, participants with diabetic neuropathy and a previously healed plantar ulcer received either an insole system that alerted them when sustained high pressure was detected, or a standard insole without alerts. Of 90 participants enrolled, 58 completed the study (32 intervention, 26 control).
The intervention group developed 4 ulcers over 11,835 person-days of follow-up, compared with 10 ulcers over 8,638 person-days in controls, an incidence rate ratio of 0.29 (about a 71% reduction; p=0.037). Among participants who used the system consistently, the reduction was reported as 86%. The number of individuals who ulcerated did not differ significantly between groups (6 versus 4; p=0.29), and plantar sites ulcerated less often in the intervention group (4 of 512 sites versus 10 of 416; p=0.047).
Interpreting the Results Carefully
These findings are encouraging but limited. The trial was small, described by its authors as proof-of-concept, and about one-third of participants did not complete it. The difference in the proportion of people who developed an ulcer was not statistically significant, and the benefit appeared larger in adherent users, a pattern that can reflect healthier habits as well as the device. Larger, adequately powered trials are needed; a multicentre randomized trial of wearable insoles for recurrent ulcer prevention (WIREDUP) is registered on ClinicalTrials.gov.
How This Compares With Temperature Monitoring
A related approach is daily at-home measurement of foot skin temperature, since a persistent temperature difference between feet may signal inflammation before a wound appears. A meta-analysis by Golledge and colleagues (Diabetes/Metabolism Research and Reviews, 2022) pooled five randomized trials with 772 participants at moderate to high risk. Monitoring combined with activity reduction after a hotspot was associated with roughly half the risk of ulceration (relative risk 0.51; 95% CI 0.31–0.84), although the certainty of evidence was rated low because of methodological limitations and inconsistency between trials.
Pressure sensing and temperature monitoring measure different phenomena: pressure reflects mechanical load before injury, whereas temperature reflects inflammatory response once tissue stress has begun. Neither has been shown to replace conventional prevention, and both depend on the person responding to alerts by offloading the foot.
Practical Considerations
Several factors affect whether any monitoring technology benefits patients: consistent daily use, the ability to see or hear alerts, access to a reliable footwear fit, and a clear plan for what to do when an alert occurs. Technology also does not address other drivers of ulceration such as peripheral artery disease, deformity, or unsuitable footwear. Cost and access remain open questions, and current guidelines position these tools as adjuncts rather than standard of care.
Key Takeaways
Insole-based plantar pressure monitoring with alerts reduced ulcer incidence in one small randomized proof-of-concept trial, and home temperature monitoring has low-certainty pooled evidence of benefit. Both illustrate a broader principle: extending surveillance into daily life may help compensate for absent protective sensation. Until larger trials are completed, these tools are best understood as promising complements to established measures such as therapeutic footwear, regular professional foot examination, and patient education.
References
- Abbott CA, Chatwin KE, Foden P, et al. Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. The Lancet Digital Health. 2019.
- Golledge J, Fernando ME, Alahakoon C, Lazzarini PA, aan de Stegge WB, van Netten JJ, Bus SA. Efficacy of at home monitoring of foot temperature for risk reduction of diabetes-related foot ulcer: a meta-analysis. Diabetes/Metabolism Research and Reviews. 2022.
- Bus SA, Sacco ICN, Monteiro-Soares M, et al. Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2023 update). Diabetes/Metabolism Research and Reviews. 2024.
- Bus SA, van Netten JJ. A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable. Diabetes/Metabolism Research and Reviews. 2016.
Comments
