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Treatment of Cutaneous Ulcers With a Novel Biological Dressing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207818
First Posted: September 21, 2005
Last Update Posted: February 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Cutaneous Ulcers With a Novel Biological Dressing

Further study details as provided by CHU de Quebec-Universite Laval:

Primary Outcome Measures:
  • wound closure

Secondary Outcome Measures:
  • % of healing at 6 months of treatment

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207818


Locations
Canada
Centre hospitalier affilie universitaire de Quebec
Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
CHU de Quebec-Universite Laval
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: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT00207818     History of Changes
Other Study ID Numbers: LOEX 005
29478 Health Canada
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by CHU de Quebec-Universite Laval:
tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care

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