Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers (SANIBA)
|Diabetes Mellitus Diabetic Neuropathic Foot Ulcer||Device: SANIDIAB Device: BAROUK||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effectiveness and Safety of an Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers of the Fore Foot: a Prospective Randomised Pilot Study|
- Healing duration of the diabetic foot ulcer [ Time Frame: 6 months ]
- Rate of reulceration [ Time Frame: 6 months ]
- Rate of amputation [ Time Frame: 6 months ]
- Compliance of patients to footwear [ Time Frame: 6 months ]
|Study Start Date:||June 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: barouk||
Name of the study : SANIBA
The gold standard to heal diabetic foot ulcers is complete off-loading. To wear continuously off loading shoe is very difficult The bad compliance of the patients can lead to infection of the ulcer and amputation of the foot.
The purpose of this study is to compare the efficacy of a new concept of off-loading shoe (a pair of SANIDIAB shoes) with a single BAROUK shoe to treat chronic plantar diabetic foot ulcer of the fore foot. The hypothesis is that the new concept is more efficient because of a good off-loading associated with a best compliance to wear the new concept of shoes.
The study will last 18 months with a duration of study of 6 months per patient It's a pilot prospective multicenter randomised study of 64 diabetic patients with a plantar neuropathic ulcer of the fore foot, treated after randomisation by an off loading shoe BAROUK or a pair of off loading shoes SANIDIAB.
Patients will be followed in a diabetic foot department every 14 days until healing and after healing until 6 months after inclusion in the study.
The main outcome measure is the healing duration of the diabetic foot ulcers in both group of treatment.
The secondary outcome measure is the rate of reulceration after healing , the rate of amputation and compliance of patients 64 patients will be included in 2 groups: 32 will wear SANIDIAB shoes and 32 BAROUK shoe.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586481
|Groupe hospitalier Pitié-Salpêtrière|
|Paris, France, 75013|
|Principal Investigator:||Georges HA VAN, MD||APHP|