MedTrace Logo

A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa

NCT01619670 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2015-03-10

No results posted yet for this study

Summary

Epidermolysis Bullosa (EB) is a very rare disease, with a severe impact on the life of the patient and the caregiver. Epidermolysis Bullosa (EB) comprises a group of genetically determined skin fragility disorders characterized by blistering of the skin and mucosae following mild mechanical trauma. There is no specific proven treatment for any form of EB, and the mainstay of clinical management is based on protection and avoidance of provoking factors. Chronic nonhealing erosions and ulcers have been treated with conventional split-thickness skin grafts. Alternatively some patients may benefit from the use of autologous or allogeneic cultured keratinocyte grafts.

Conditions

  • Epidermolysis Bullosa
  • Wound Healing

Interventions

DEVICE

Apligraf

non adhesive layer

Sponsors & Collaborators

  • Organogenesis

    collaborator INDUSTRY

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Andreas Arnold, MD · University Hospital Basel, Dep. Dermatology and Venereology, Basel/Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01619670 on ClinicalTrials.gov