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NCT Number: NCT01586481

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

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

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Key information

Conditions

Diabetes Mellitus Behavior Cardiovascular Diseases Diabetes Complications Diabetic Angiopathies Diabetic Foot Diabetic Neuropathic Foot Ulcer Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Health Behavior Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Groupe hospitalier Pitié-Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SANIDIAB

Device

off-loading shoe

BAROUK

Device

old shoe

Primary outcomes

  1. Healing duration of the diabetic foot ulcer

    Time frame: 6 months

Secondary outcomes

  1. Rate of reulceration

    Time frame: 6 months

  2. Rate of amputation

    Time frame: 6 months

  3. Compliance of patients to footwear

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • MAYZAUD

Registry information

Official study 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

Acronym: SANIBA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2012
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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