1. Diabetes
Conditions
Interventions
Therapeutic (orthopedic) footwear optimized and monitored using plantar pressure distribution measurement (Intervention group).
Therapeutic (orthopedic) footwear manufactured and monitored according
Sponsors
Academic Medical Center, Amsterdam, the Netherlands.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 and <85 years old; 2. Diabetes mellitus type 1 or 2; 3. Loss of protective sensation due to peripheral neuropathy; 4. History of plantar foot ulceration within the last 18 months; 5. A new therapeutic footwear prescription.
Exclusion criteria
Exclusion criteria: 1. Active foot ulceration; 2. Amputation proximal to the metatarsal bones; 3. Severe illness that would make 18-months survival unlikely; 4. The use of walking aids that contribute to offloading the foot; 5. Parallel participation in another study that may influence the outcomes of this study; 6. Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a plantar diabetic foot ulcer within an 18-month follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In-shoe peak plantar pressures; 2. Barefoot peak plantar pressures; 3. Cost-effectiveness and cost-utility; 4. Perceived footwear usability; 5. Footwear use (adherence); 6. Number of steps made per day (daily activity level). | — |
Contacts
Public ContactS.A. Bus
Department of Rehabilitation Academic Medical Center University of Amsterdam P.O. Box 22700
Outcome results
None listed