Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 25, 2012
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
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 ...
Gender
ALL
Eligibility 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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Patients applied
Trial Officials
Georges HA VAN, MD
Principal Investigator
APHP
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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