Foot Ulcer, Diabetic Clinical Trial
Official title:
Evaluation of a New Customized Removable Device With Rocker Sole for Plantar Off-Loading "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients
Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication
committee (PROBE methodology), comparing "Orthèse Diabète" with "conventional" removable
devices in terms of healing of ulcers.
- Primary objective: Evaluate the efficiency of "Orthèse Diabète" compared to "conventional"
removable devices, in terms of the proportion of diabetic patients whose principal ulcer
will heal completely at 3 months.
1. Secondary objectives
1. Proportion of patients whose principal ulcer will heal completely at 1, 2 and 6
months
2. Proportion of patients in whom all initial plantar ulcers will heal completely at
1, 2, 3 and 6 months
3. Percentage of area decrease of the plantar ulcers at 1, 2, 3 and 6 months
4. Time to healing of the principal ulcer
5. Appearance of new ulcers
6. Requirement for amputation
7. Incidence of the infectious complications
8. Adherence of wearing
9. Patient's satisfaction with the prescribed device
2. Population
1. 13 centers/116 patients monitored for a period of 6 months maximum
2. Experimental Group: "Orthèse Diabète" a plantar off-loading custom-made removable
device
3. Control group: "Conventional" removable off-loading systems among the devices
available in France.
;
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