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Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers

NCT ID: NCT01586481

Last Updated: 2013-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Diabetic Neuropathic Foot Ulcer

Keywords

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Diabetic foot ulcer Off loading Compliance Healing duration Amputation rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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barouk

Group Type ACTIVE_COMPARATOR

BAROUK

Intervention Type DEVICE

old shoe

sanidiab

Group Type EXPERIMENTAL

SANIDIAB

Intervention Type DEVICE

off-loading shoe

Interventions

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SANIDIAB

off-loading shoe

Intervention Type DEVICE

BAROUK

old shoe

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MAYZAUD

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georges HA VAN, MD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Groupe hospitalier Pitié-Salpêtrière

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P090501

Identifier Type: -

Identifier Source: org_study_id