Epidermolysis Bullosa Dystrophica, Recessive, Ulcer
Conditions
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.
Interventions
DEVICEAmniotic Membrane
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of ulcerated area re-epithelialised | at 12 weeks from the start of treatment |
Countries
France
Contacts
Primary Contactmatthieu resche-rigon, MD-PHD
Backup Contactemmanuelle BOURRAT, MD
Outcome results
None listed