Treatment of Cutaneous Ulcers With a Novel Biological Dressing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT00207818
First received: September 13, 2005
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

The aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.


Condition Intervention Phase
Venous Ulcers
Device: self assembled skin substitute (SASS)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Cutaneous Ulcers With a Novel Biological Dressing

Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • wound closure [ Designated as safety issue: No ]
    -


Secondary Outcome Measures:
  • % of healing at 6 months of treatment [ Designated as safety issue: No ]
    -


Enrollment: 6
Study Start Date: September 1999
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: self assembled skin substitute (SASS)
    Wound care with self assembled skin substitute (SASS)
Detailed Description:

The hypothesis of this trial is that the cutaneous model SASS, a dermal epidermal skin substitute, created by the LOEX could be as high-performant, or even better, than the one's already existent in North America for the wound care. We anticipate showing on 6 patients that ulcer that did not close with conventional treatment, will heal or at least improve with this treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women from 18 to 85 years old
  2. Have a venous ulcer or a mixed ulcer

Exclusion Criteria:

Diabetes Mental deficiency Hepatitis holder (A-B-C) HIV positive Pregnancy or lactation Corticosteroids therapy Radiotherapy Chemotherapy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207818

Locations
Canada
Centre hospitalier affilie universitaire de Quebec
Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Investigators
Principal Investigator: Francois A Auger, MD Centre hospitalier affilié universitaire de Québec
Study Director: Lucie Germain, Ph.D. Centre hospitalier affilié universitaire de Québec
  More Information

Additional Information:
Publications:
Responsible Party: Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT00207818     History of Changes
Other Study ID Numbers: LOEX 005, 29478 Health Canada
Study First Received: September 13, 2005
Last Updated: February 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care

Additional relevant MeSH terms:
Skin Ulcer
Ulcer
Varicose Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer

ClinicalTrials.gov processed this record on April 17, 2014