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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Diabetic Neuropathic Foot Ulcer
• Intervention / Treatment: Device: BAROUK; Device: SANIDIAB

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Groupe Hospitalier Pitie-Salpetriere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: barouk	Device: BAROUK; old shoe
Experimental: sanidiab	Device: SANIDIAB; off-loading shoe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Healing duration of the diabetic foot ulcer	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of reulceration	6 months
Rate of amputation	6 months
Compliance of patients to footwear	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: MAYZAUD
• Investigators: Principal Investigator: Georges HA VAN, MD, APHP

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: April 25, 2012
• First Submitted That Met QC Criteria: April 25, 2012
• First Posted (Estimate): April 26, 2012

Study Record Updates

• Last Update Posted (Estimate): November 14, 2013
• Last Update Submitted That Met QC Criteria: November 13, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer; Compliance; Off loading; Healing duration; Amputation rate
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Leg Ulcer; Skin Ulcer; Foot Diseases; Foot Ulcer; Ulcer; Recurrence
• Other Study ID Numbers: P090501