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

Primary Purpose

Epidermolysis Bullosa Dystrophica, Recessive, Ulcer

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Amniotic Membrane
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidermolysis Bullosa Dystrophica, Recessive

Eligibility Criteria

2 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saint-Louis HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Dressing

Amniotic Membrane

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Percentage of ulcerated area re-epithelialised

Secondary Outcome Measures

Full Information

First Posted
November 5, 2014
Last Updated
November 3, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02286427
Brief Title
A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane
Acronym
MABUL
Official Title
A Comparative Study of the Healing of Chronic Skin Ulcers of Recessive Dystrophic Epidermolysis Bullosa : Standard Dressing Versus Amniotic Membrane.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermolysis Bullosa Dystrophica, Recessive, Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Dressing
Arm Type
Active Comparator
Arm Description
J0 to J42 : once a week, primary dressing with Mepitel®
Arm Title
Amniotic Membrane
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Amniotic Membrane
Primary Outcome Measure Information:
Title
Percentage of ulcerated area re-epithelialised
Time Frame
at 12 weeks from the start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
matthieu resche-rigon, MD-PHD
Phone
142499742
Ext
+33
Email
matthieu.resche-rigon@univ-paris-diderot.fr
First Name & Middle Initial & Last Name or Official Title & Degree
emmanuelle BOURRAT, MD
Email
emmanuelle.bourrat@rdb.aphp.fr
Facility Information:
Facility Name
Saint-Louis Hospital
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
emmannuelle bourrat, md
Phone
142499742
Ext
33
Email
emmanuelle.bourrat@aphp.fr
First Name & Middle Initial & Last Name & Degree
matthieu resche-rigon, md phd
Phone
142499742
Ext
33
Email
matthieu.resche-rigon@univ-paris-diderot.fr

12. IPD Sharing Statement

Learn more about this trial

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

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