A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane (MABUL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02286427|
Recruitment Status : Unknown
Verified November 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : November 7, 2014
Last Update Posted : November 4, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Epidermolysis Bullosa Dystrophica, Recessive Ulcer||Device: Amniotic Membrane||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Comparative Study of the Healing of Chronic Skin Ulcers of Recessive Dystrophic Epidermolysis Bullosa : Standard Dressing Versus Amniotic Membrane.|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2020|
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
- Percentage of ulcerated area re-epithelialised [ Time Frame: at 12 weeks from the start of treatment ]
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): NCT02286427
|Contact: matthieu resche-rigon, MD-PHD||142499742 ext +firstname.lastname@example.org|
|Contact: emmanuelle BOURRAT, MDemail@example.com|