Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers (SANIBA)
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Purpose
It's a pilot prospective opened multicentric randomised study. We measure the efficiency and the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK) to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with BAROUK shoe
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Diabetic Neuropathic Foot Ulcer |
Device: SANIDIAB Device: BAROUK |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 ] [ Designated as safety issue: Yes ]
- Rate of reulceration [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Rate of amputation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Compliance of patients to footwear [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 64 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: barouk |
Device: BAROUK
old shoe
|
| Experimental: sanidiab |
Device: SANIDIAB
off-loading shoe
|
Detailed Description:
Name of the study : SANIBA
Objective:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria :
- More of 18 years old man or woman
- Type 1 or 2 Diabetes mellitus
- A new plantar ulcer of the fore foot or the toes
- GRADE 1A or 2 A of the University of Texas Classification
- Neuropathy assessed by absence of sensation in 10g monofilament test
Exclusion criteria
- Severe angiopathy (Grade 3 of the PEDIS classification)
- Osteomyelitis or cellulitis of the foot
- Transmetatarsal amputation
- Other study in course
- Immunosuppressive drugs, antibiotic therapy,
- Hepatic insufficiency
- No possibility to follow the patients every 14 days
- No state health insurance
- Pregnancy
Contacts and Locations| Contact: Georges HA VAN, MD | +33(0) 1 42 17 80 53 |
| France | |
| Groupe hospitalier Pitié-Salpêtrière | Recruiting |
| Paris, France, 75013 | |
| Contact: Georges HA VAN, MD +33(0) 1 42 17 80 53 | |
| Principal Investigator: | Georges HA VAN, MD | APHP |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01586481 History of Changes |
| Other Study ID Numbers: | P090501 |
| Study First Received: | April 25, 2012 |
| Last Updated: | May 13, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Diabetic foot ulcer Off loading Compliance Healing duration Amputation rate |
Additional relevant MeSH terms:
|
Diabetes Mellitus Recurrence Ulcer Foot Ulcer Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Disease Attributes Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer |
ClinicalTrials.gov processed this record on June 18, 2013