Diabetes Mellitus Clinical Trial
— SANIBAOfficial 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
Verified date | May 2013 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 33 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Groupe hospitalier Pitié-Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | MAYZAUD |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Healing duration of the diabetic foot ulcer | 6 months | Yes | |
Secondary | Rate of reulceration | 6 months | Yes | |
Secondary | Rate of amputation | 6 months | Yes | |
Secondary | Compliance of patients to footwear | 6 months | No |
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