Clinical trial NCT01586481: Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Diabetic Neuropathic Foot Ulcer
Keywords: Diabetic foot ulcer
Off loading
Compliance
Healing duration
Amputation rate
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: MAYZAUD
First posted: 2012-04-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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 criteria: 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

Primary outcomes:
measure: Healing duration of the diabetic foot ulcer
timeFrame: 6 months
Secondary outcomes:
measure: Rate of reulceration
timeFrame: 6 months
measure: Rate of amputation
timeFrame: 6 months
measure: Compliance of patients to footwear
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe hospitalier Pitié-Salpêtrière
Study officials:
affiliation: APHP
name: Georges HA VAN, MD
role: PRINCIPAL_INVESTIGATOR
References: