NCT02286427

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

A Comparative Study of the Healing of Chronic Skin Ulcers of Recessive Dystrophic Epidermolysis Bullosa : Standard Dressing Versus Amniotic Membrane.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 2 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epidermolysis Bullosa Dystrophica, Recessive
• Ulcer

Interventions

Type	Name	Description
DEVICE	Amniotic Membrane

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-01-01
• Completion: 2020-01-01
• First posted: 2014-11-07
• Last updated: 2016-11-04

Locations

1 site across 1 country: France