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

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ClinicalTrials.gov Identifier: NCT02286427
Recruitment Status : Recruiting
First Posted : November 7, 2014
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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


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



Primary Outcome Measures :
  1. Percentage of ulcerated area re-epithelialised [ Time Frame: at 12 weeks from the start of treatment ]


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Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: matthieu resche-rigon, MD-PHD 142499742 ext +33 matthieu.resche-rigon@univ-paris-diderot.fr
Contact: emmanuelle BOURRAT, MD emmanuelle.bourrat@rdb.aphp.fr

Locations
France
Saint-Louis Hospital Recruiting
Paris, France, 75010
Contact: emmannuelle bourrat, md    142499742 ext 33    emmanuelle.bourrat@aphp.fr   
Contact: matthieu resche-rigon, md phd    142499742 ext 33    matthieu.resche-rigon@univ-paris-diderot.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02286427     History of Changes
Other Study ID Numbers: P130907 - 2014-001805-42
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica
Ulcer
Pathologic Processes
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Collagen Diseases
Connective Tissue Diseases