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

NCT ID: NCT02286427

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-01-31

Brief Summary

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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

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Conditions

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Epidermolysis Bullosa Dystrophica, Recessive Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Dressing

J0 to J42 : once a week, primary dressing with Mepitel®

Group Type ACTIVE_COMPARATOR

Amniotic Membrane

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Amniotic Membrane

Intervention Type DEVICE

Interventions

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Amniotic Membrane

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saint-Louis Hospital

Paris, Paris, France

Site Status RECRUITING

Countries

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France

Central Contacts

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matthieu resche-rigon, MD-PHD

Role: CONTACT

Phone: 142499742

Email: [email protected]

emmanuelle BOURRAT, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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emmannuelle bourrat, md

Role: primary

matthieu resche-rigon, md phd

Role: backup

Other Identifiers

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P130907 - 2014-001805-42

Identifier Type: -

Identifier Source: org_study_id