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

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ClinicalTrials.gov Identifier: NCT01586481
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : November 14, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Neuropathic Foot Ulcer Device: SANIDIAB Device: BAROUK Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2011
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: barouk Device: BAROUK
old shoe
Experimental: sanidiab Device: SANIDIAB
off-loading shoe


Outcome Measures

Primary Outcome Measures :
  1. Healing duration of the diabetic foot ulcer [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586481


Locations
France
Groupe hospitalier Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
MAYZAUD
Investigators
Principal Investigator: Georges HA VAN, MD APHP
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01586481     History of Changes
Other Study ID Numbers: P090501
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: May 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Diabetic foot ulcer
Off loading
Compliance
Healing duration
Amputation rate

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Recurrence
Foot Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Disease Attributes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer