Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||2 Years - 60 Years|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Assistance Publique - Hôpitaux de Paris|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Epidermolysis Bullosa Dystrophica, Recessive, Ulcer|
Active Comparator: Standard Dressing
J0 to J42 : once a week, primary dressing with Mepitel®
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
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.