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Sponsored by: |
Centre Hospitalier Affilie, Universitaire de Quebec |
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Information provided by: | Centre Hospitalier Affilie, Universitaire de Quebec |
ClinicalTrials.gov Identifier: | NCT00207818 |
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 |
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Venous Ulcers |
Device: self assembled skin substitute (SASS) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Treatment of Cutaneous Ulcers With a Novel Biological Dressing |
Estimated Enrollment: | 6 |
Study Start Date: | September 1999 |
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Diabetes Mental deficiency Hepatitis holder (A-B-C) HIV positive Pregnancy or lactation Corticosteroids therapy Radiotherapy Chemotherapy
Contact: Francois A Auger, MD | 418 682-7663 | francois.auger@chg.ulaval.ca |
Contact: Lucie Germain, Ph.D. | 418 682-7663 | lucie.germain@chg.ulaval.ca |
Canada | |
Centre hospitalier affilie universitaire de Quebec Hop St-Sacrement | Recruiting |
Quebec, Canada, G1S 4L8 | |
Contact: Jacques Soucy, MD 418 649-5520 f | |
Contact: Carlos E. Ospina, MD 418 682-7663 francois.auger@chg.ulaval.ca |
Principal Investigator: | Francois A Auger, MD | Centre hospitalier affilié universitaire de Québec |
Study Director: | Lucie Germain, Ph.D. | Centre hospitalier affilié universitaire de Québec |
Study ID Numbers: | LOEX 005, 29478 Health Canada |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00207818 |
Health Authority: | Canada: Health Canada |
tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care |
Varicose Ulcer Varicose Veins Skin Diseases Ulcer |
Vascular Diseases Skin Ulcer Leg Ulcer |
Pathologic Processes Cardiovascular Diseases |