We’ve long known that custom-made footwear plays a central role in preventing diabetic foot ulcers. But ensuring people actually wear this footwear—particularly at home—remains a challenge. A new study by Van Netten, Vossen, Driebergen, Wolthuis, Merkx, and Bus offers important insight into this issue by exploring a multi-modal behavioral intervention to improve adherence.
In this short-term evaluation—part of the ongoing DIASSIST trial—the team tested a combined approach including:
- Structured education, built on the Fragile Feet–Trivial Trauma (FF-TT) model.
- Motivational interviewing, delivered over the phone using a tailored MI protocol.
- Custom-made indoor footwear, provided to address common barriers like comfort, ease of donning, and hygiene.
The intervention was tested in 53 people at high risk for ulceration, all of whom had healed from a recent ulcer and were already prescribed custom footwear. About 57% had low baseline adherence (defined as <8 hours/day of wear time). Participants wore footwear with embedded sensors to objectively capture wear time.
Key findings:
- Structured education alone showed a clinically meaningful, though not statistically significant, increase in daily wear time for those with low baseline adherence (+1.0 h/day, p = 0.098).
- Motivational interviewing did not produce significant changes in adherence.
- Custom-made indoor footwear significantly increased wear time in both low and high adherence groups (+2.7 and +2.0 h/day, respectively; p < 0.01) .
While the combined intervention did not yield statistically significant changes at the 3-month mark overall, the effect of indoor footwear was immediate and notable. Participants reported greater ease and willingness to wear footwear consistently indoors—one of the persistent gaps in adherence.
Why this matters:
For clinicians and care teams focused on limb preservation, these findings provide a clear path forward:
- Structured education is low-cost and easy to implement, with potential for meaningful impact.
- While motivational interviewing remains promising in other domains, its role in footwear adherence may be limited—especially without multiple sessions or a strong therapeutic alliance.
- Custom-made indoor footwear appears to be an actionable and effective lever to improve at-home adherence.
Looking ahead:
The full 12-month results from the DIASSIST trial are still to come and may clarify the long-term impact of each intervention component. For now, the short-term data support an evidence-informed pivot toward personalized education and indoor footwear access as pillars of DFU prevention programs.
Citation:
Van Netten JJ, Vossen LE, Driebergen FM, Wolthuis D, Merkx MJM, Bus SA, “Short-Term Efficacy of a Multi-Modal Intervention Program to Improve Custom-Made Footwear Use in People at High Risk of Diabetes-Related Foot Ulceration,” J Clin Med. 2025;14(11):3635. https://doi.org/10.3390/jcm14113635
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