NCT01956162

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Proteor Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2013-10-08
• Last updated: 2017-06-01

Locations

1 site across 1 country: France