No registrations found.
ID
Source
Brief title
Health condition
1. Diabetes;
2. Diabetic foot;
3. Neuropathy;
4. Footwear;
5. Plantar pressure.
Sponsors and support
Zon MW Clinical Fellowship (M. de Haart)
Intervention
Outcome measures
Primary outcome
Proportion of patients with a plantar diabetic foot ulcer within an 18-month follow-up period.
Secondary outcome
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).
Background summary
The purpose of this multicenter randomized controlled trial is to assess the effectiveness of incorporating foot pressure measurements in the manufacturing of therapeutic footwear to guarantee adequate off-loading properties and as a method of monitoring the off-loading properties over time in preventing the recurrence of plantar foot ulcers in patients with diabetes mellitus.
Study objective
Therapeutic footwear of which adequate off-loading properties are guaranteed and monitored by dynamic plantar pressure assessment will result in a reduced plantar re-ulceration rate in diabetic patients with prior plantar foot ulceration compared to footwear manufactured and monitored according to current practice.
Study design
Baseline assessment;
Entry visit (0 months);
Follow-up visits each 3 months for 18 months
Intervention
Therapeutic (orthopedic) footwear optimized and monitored using plantar pressure distribution measurement (Intervention group).
Therapeutic (orthopedic) footwear manufactured and monitored according to current clinical practice (Control group)
Academic Medical Center
University of Amsterdam
P.O. Box 22700
S.A. Bus
Amsterdam 1100 DE
The Netherlands
+31 20 5666905
s.a.bus@amc.nl
Academic Medical Center
University of Amsterdam
P.O. Box 22700
S.A. Bus
Amsterdam 1100 DE
The Netherlands
+31 20 5666905
s.a.bus@amc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1058 |
| NTR-old | NTR1091 |
| Other | : wordt doorgegeven |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |