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

Phase 3

• Conditions: Ulcer; Epidermolysis Bullosa Dystrophica, Recessive
• Interventions: Device: Amniotic Membrane

• Registration Number: NCT02286427
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-07
• Study Start: 2015-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04
• Primary Completion: 2018-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amniotic Membrane	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.
Standard Dressing	Amniotic Membrane	J0 to J42 : once a week, primary dressing with Mepitel®

Primary Outcome Measures

Name	Time	Method
Percentage of ulcerated area re-epithelialised	at 12 weeks from the start of treatment

Trial Locations

Locations (1)

Saint-Louis Hospital; 🇫🇷 Paris, France