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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01956162
Study type Interventional
Source Proteor Group
Contact
Status Completed
Phase N/A
Start date October 2013
Completion date December 2016

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