A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane (MABUL)

November 3, 2016 updated by: Assistance Publique - Hôpitaux de Paris

A Comparative Study of the Healing of Chronic Skin Ulcers of Recessive Dystrophic Epidermolysis Bullosa : Standard Dressing Versus Amniotic Membrane.

Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain, superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but clinical experience suggests that most epidermise in less than a month. Some, however, for unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined for this study as lasting more than three months are a source of major discomfort and could play a decisive role in the morbidity and mortality of the disease.

The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3) from the start of treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 2 years and 60
  • REBD clinically evident with immunohistological confirmation and / or genetic
  • REBD with at least two chronic ulcers (> 3 months) comparable
  • Signing the informed consent of the patient and / or (children) of parents holding parental authority
  • Affiliation to a social security scheme (beneficiary or legal)

Exclusion Criteria:

  • Epidermoid carcinoma on the target or chronic ulcers
  • Budding excessive requiring the application of a topical corticosteroid on the target or chronic ulcers
  • Skin bacterial superinfection clinically overt requiring oral antibiotics
  • Herpes simplex virus superinfection
  • major evolutionary and malnutrition defined as a BMI <12 or more than 2 variant between screening and randomization OR a serum albumin <20 g / l or more ranging from 5 g / l between screening and randomization
  • major and progressive anemia defined by a Hb <6 g / liter or variant more than 4 g / l between screening and randomization
  • Life expectancy estimated at less than 3 months
  • Pregnancy
  • Inability to understand or observance of the rules of protocol
  • Participation in another interventional therapeutic biomedical research whose treatment is not yet completed or the primary endpoint is not yet measured at the time of inclusion in Mabul

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Dressing
J0 to J42 : once a week, primary dressing with Mepitel®
Device: Amniotic Membrane
Experimental: Amniotic Membrane
J0 to J42: once a week, Mepitel® and amniotic membrane (one or several depending on the graft size, so that the ulcer was completely covered with MAH). The last amniotic membrane is left in place.
Device: Amniotic Membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of ulcerated area re-epithelialised
Time Frame: at 12 weeks from the start of treatment
at 12 weeks from the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 7, 2014

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P130907 - 2014-001805-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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