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Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients

NCT01956162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2017-06-01

No results posted yet for this study

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.

Conditions

  • Foot Ulcer, Diabetic

Interventions

DEVICE

Orthèse Diabète

The device ensures the discharge of the wound by the excavation of the orthopedic insole facing the wound and the load distribution in the healthy areas.

DEVICE

"Conventional" Device

Standard (e.g.: CHUT, BAROUK, Tera-Diab, Sanital, Teraheel, Aircast boots, Walker Stabil D, etc.), or customized (orthopedic insole, Ransart boot, D.T.A.C.P., etc.) removable off-loading systems

Sponsors & Collaborators

  • Société Francophone du Diabète

    collaborator OTHER

  • Proteor Group

    lead INDUSTRY

Principal Investigators

  • Kamel Mohammedi, Diabetology · Bichat Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01956162 on ClinicalTrials.gov