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

This study has been completed.
Sponsor:
Collaborator:
MAYZAUD
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01586481
First received: April 25, 2012
Last updated: November 13, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Diabetes Mellitus
Diabetic Neuropathic Foot Ulcer
Device: SANIDIAB
Device: BAROUK
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Healing duration of the diabetic foot ulcer [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of reulceration [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Rate of amputation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Compliance of patients to footwear [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: barouk Device: BAROUK
old shoe
Experimental: sanidiab Device: SANIDIAB
off-loading 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01586481     History of Changes
Other Study ID Numbers: P090501
Study First Received: April 25, 2012
Last Updated: November 13, 2013
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 26, 2014