NCT05236660

Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

Cost-utility of an Integrated Personalised Assistive Devices Approach to Reduce Foot Ulcer Recurrence in Diabetes (DIASSIST): a Multicentre Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Preventing foot ulcers in people with diabetes can reduce costs and increase quality of life. Despite availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesise that a multimodal approach incorporating a variety of orthotic interventions that matches an individual person's need can reduce ulcer recurrence with beneficial cost-effectiveness and cost-utility.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Custom-made shoes: pressure-optimized	Pressure-optimized custom-made shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months.
DEVICE	Custom-made indoor shoes: pressure optimized	Pressure-optimized custom-made indoor shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months. Specifically designed for indoor use.
DEVICE	Foot temperature monitoring	Personalised at-home daily foot temperature monitoring at high-risk regions.
BEHAVIORAL	Education	Personalised patient education consisting of quantitative feedback on in-shoe pressures, temperature measurements and footwear use and, in addition, motivational interviewing where indicated and needed to improve device use.

Timeline

• Start date: 2022-03-02
• Primary completion: 2025-10-02
• Completion: 2025-10-02
• First posted: 2022-02-11
• Last updated: 2026-01-06

Locations

5 sites across 1 country: Netherlands