NCT02286427

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

November 5, 2014

Last Update Submit

November 3, 2016

Conditions

Epidermolysis Bullosa Dystrophica, RecessiveUlcer

Outcome Measures

Primary Outcomes (1)

  • Percentage of ulcerated area re-epithelialised

    at 12 weeks from the start of treatment

Study Arms (2)

Standard Dressing

ACTIVE COMPARATOR

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

Device: Amniotic Membrane

Amniotic Membrane

EXPERIMENTAL

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

Interventions

Amniotic MembraneDEVICE
Amniotic MembraneStandard Dressing

Eligibility Criteria

Age2 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint-Louis Hospital

Paris, Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Epidermolysis Bullosa DystrophicaUlcer

Interventions

Biological Dressings

Condition Hierarchy (Ancestors)

Epidermolysis BullosaSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesSkin Diseases, VesiculobullousPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Central Study Contacts

matthieu resche-rigon, MD-PHD

CONTACT

142499742matthieu.resche-rigon@univ-paris-diderot.fr

emmanuelle BOURRAT, MD

CONTACT

emmanuelle.bourrat@rdb.aphp.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 7, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2020

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

FR(1)