Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

NAActive, not recruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

March 2, 2022

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Diabetic Foot Ulcer
Interventions
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.

Trial Locations (5)

Unknown

Amsterdam UMC, Amsterdam

Rode Kruis Ziekenhuis, Beverwijk

Reinier de Graaf Gasthuis, Delft

Spaarne Gasthuis, Hoofddorp

Máxima Medisch Centrum, Veldhoven

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER