An Integrated Personalized Multimodal Intervention Improves Adherence to Wearing Custom-Made Footwear in People With Diabetes at High Foot Ulcer Risk: A Multicenter Randomized Controlled Trial (DIASSIST)
Primary result · Footwear adherenceResult — go to the resultRelative increase 34 %Authors' conclusion
Footwear adherence can be significantly increased through an integrated personalized multimodal intervention.
Study context
- Population
- People with diabetes, peripheral neuropathy, ulcer history and custom-made footwear (high foot ulcer risk)
- Participants
- 126 people
- Comparison
- Integrated personalized multimodal intervention vs usual care
- Primary endpoint
- Footwear adherence (% of steps taken wearing prescribed footwear), objectively measured
- Follow-up
- 6 and 12 months
Methodological detailsmulticenter
- Multicenter
Primary result
Footwear adherence · 6 months
Relative increase
34 %
P < 0.001
By group
As reported in the abstract
Secondary outcomes
Footwear adherence · 12 months
P = 0.013
Shoe-wearing time
- Increase after randomization visit with structured education (P = 0.049)
- 7.8-8.3 h/day
- Increase after provision of indoor-specific footwear (P < 0.001)
- 7.7-9.4 h/day
Original publication
An Integrated Personalized Multimodal Intervention Improves Adherence to Wearing Custom-Made Footwear in People With Diabetes at High Foot Ulcer Risk: A Multicenter Randomized Controlled Trial (DIASSIST). Diabetes Care. Published 5 June 2026. doi:10.
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