Healing a diabetic foot ulcer is only half the clinical problem. Roughly 40% of people whose ulcer has healed will develop a new one within a year, and about 65% will do so within five years (Armstrong et al., JAMA, 2023). The period after wound closure is therefore not a return to baseline but a distinct phase — often called ulcer remission — in which the foot remains insensate, deformed, and mechanically vulnerable. Therapeutic footwear and custom insoles are the principal long-term tools for managing that vulnerability, and the evidence supporting them has become considerably more specific over the past decade.
Why Footwear Sits at the Centre of Prevention
Plantar ulcers in diabetes are fundamentally mechanical injuries. Peripheral neuropathy removes the pain signal that would normally cause a person to change gait or stop walking, while deformity, limited joint mobility, and callus concentrate load over bony prominences. Repetitive moderate pressure applied thousands of times a day to skin that cannot report distress produces tissue breakdown. Footwear is the only intervention that acts on this mechanism during every weight-bearing step.
The 2023 International Working Group on the Diabetic Foot (IWGDF) prevention guideline reflects this reasoning. It recommends that people at moderate-to-high risk be educated to wear properly fitting, accommodative therapeutic footwear, and that those with a healed plantar ulcer be prescribed footwear with a demonstrated plantar pressure–relieving effect during walking (Bus et al., Diabetes/Metabolism Research and Reviews, 2024).
What “Demonstrated Pressure Relief” Means
The word “demonstrated” carries the weight of the recommendation. The IWGDF specifies a measurable target: at high-pressure locations, in-shoe peak pressure during walking should be reduced by at least 30% compared with the person’s current therapeutic footwear, or should fall below approximately 200 kPa. This shifts footwear prescription from an appearance-based judgment to a verifiable one, and it implies in-shoe pressure measurement or, at minimum, follow-up in which the device is modified until the target region is genuinely unloaded. Footwear that looks appropriate but does not measurably reduce load over the previous ulcer site is not doing the job it was prescribed to do.
What the Trial Evidence Shows
The systematic review and meta-analysis underpinning the IWGDF guideline pooled 40 controlled studies, 33 of them randomised trials. Pressure-optimised therapeutic footwear or insoles were associated with a reduced risk of plantar ulcer recurrence in people at high risk (risk ratio 0.62, 95% CI 0.26–1.47), rated as moderate-certainty evidence. Therapeutic footwear without demonstrated pressure optimisation showed a smaller and less certain effect (risk ratio 0.53, 95% CI 0.24–1.17, low certainty). At-home foot skin temperature monitoring performed comparably (risk ratio 0.51, 95% CI 0.31–0.84), and structured education and integrated foot care also contributed (van Netten et al., Diabetes/Metabolism Research and Reviews, 2024).
Two caveats matter. The confidence intervals are wide and cross unity — the direction of benefit is consistent, but the trials are few and modestly sized. And the review’s authors noted that almost no new intervention trials have appeared in recent years, leaving the evidence base thinner than the clinical importance of the question warrants.
Adherence: The Limiting Variable
A device that is not worn cannot redistribute pressure. Objective measurement using temperature sensors and accelerometers in 60 people at high ulcer risk found that prescribed footwear was worn during a mean of 63% of weight-bearing time. Adherence was markedly lower at home (59%) than away from home (74%) — yet participants accumulated nearly twice as much weight-bearing activity at home (2.2 versus 1.2 hours per day). Adherence was highest in the morning and afternoon and fell to 40% in the evening (Jarl et al., Journal of Foot and Ankle Research, 2024).
The implication is uncomfortable: much of the barefoot or slippered walking that carries ulcer risk happens indoors, in exactly the setting where prescribed footwear is least likely to be on the foot. This is why the IWGDF explicitly advises consistent indoor as well as outdoor wear.
A survey of 429 therapeutic footwear users identified modifiable factors associated with better adherence: higher self-efficacy, understanding that loss of protective sensation is itself a risk factor, storing therapeutic footwear visibly at home, and putting conventional footwear out of sight (Jarl et al., Journal of Foot and Ankle Research, 2020). People with no prior ulcer experience were more prone to non-adherence — the group for whom prevention would be most valuable.
Reloading the Foot After Closure
Recently healed skin is not equivalent to intact skin. A 2025 clinical practice guideline on the post-closure period recommends maximal offloading in the first three months after healing, followed by graded reintroduction of load using a structured footwear schedule rather than an immediate return to previous activity (Wendland et al., Physical Therapy, 2025). Its authors also identify the optimal reloading protocol as a research gap.
Clinical Summary
Therapeutic footwear reduces plantar ulcer recurrence when it demonstrably lowers pressure at the at-risk site and when it is actually worn. Both conditions matter, and both are frequently unmet. The measurable target — roughly a 30% peak pressure reduction or below 200 kPa — gives clinicians an objective endpoint, while adherence data show the largest gap lies indoors, during the hours of greatest cumulative weight-bearing. In the first three months after closure, offloading needs to remain aggressive before load is gradually reintroduced. Footwear is best understood not as a product dispensed once, but as a monitored component of long-term care.
References
- Bus SA, Sacco ICN, Monteiro-Soares M, Raspovic A, Paton J, Rasmussen A, Lavery LA, van Netten JJ. Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2023 update). Diabetes/Metabolism Research and Reviews. 2024;40(3):e3651.
- van Netten JJ, Raspovic A, Lavery LA, Monteiro-Soares M, Paton J, Rasmussen A, Sacco ICN, Bus SA. Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta-analysis. Diabetes/Metabolism Research and Reviews. 2024;40(3):e3652.
- Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023;330(1):62–75.
- Jarl G, Hulshof CM, Tijhuis KA, Busch-Westbroek TE, Bus SA, van Netten JJ. Adherence to wearing prescribed footwear in people at risk of diabetes-related foot ulcers. Journal of Foot and Ankle Research. 2024;17(3):e70002.
- Jarl G, Tranberg R, Johansson U, Alnemo J, Lundqvist LO. Predictors of adherence to wearing therapeutic footwear among people with diabetes. Journal of Foot and Ankle Research. 2020;13(1):45.
- Wendland DM, Altenburger EA, Swen SB, Haan JD. Diabetic Foot Ulcer Beyond Wound Closure: Clinical Practice Guideline. Physical Therapy. 2025;105(1):pzae171.
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