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

Ulcer Clinical Trial

— MABUL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02286427
• Other study ID #: P130907 - 2014-001805-42
• Status: Recruiting
• Phase: Phase 3
• First received: November 5, 2014
• Last updated: November 3, 2016
• Start date: January 2015
• Est. completion date: January 2020

Study information

• Verified date: November 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: matthieu resche-rigon, MD-PHD
• Phone: 142499742
• Email: matthieu.resche-rigon[@]univ-paris-diderot.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesFrance: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: January 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epidermolysis Bullosa
• Epidermolysis Bullosa Dystrophica
• Epidermolysis Bullosa Dystrophica, Recessive
• Ulcer

Intervention

Device:
• Amniotic Membrane

Locations

Country	Name	City	State
France	Saint-Louis Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of ulcerated area re-epithelialised		at 12 weeks from the start of treatment	Yes