Status:
UNKNOWN
A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Epidermolysis Bullosa Dystrophica, Recessive
Ulcer
Eligibility:
All Genders
2-60 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02286427
Start Date
January 1 2015
End Date
January 1 2020
Last Update
November 4 2016
Active Locations (1)
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1
Saint-Louis Hospital
Paris, Paris, France, 75010