Treatment of Cutaneous Ulcers With a Novel Biological Dressing

This study is currently recruiting participants.

Verified by Centre Hospitalier Affilie, Universitaire de Quebec, September 2005

Sponsored by:	Centre Hospitalier Affilie, Universitaire de Quebec
Information provided by:	Centre Hospitalier Affilie, Universitaire de Quebec
ClinicalTrials.gov Identifier:	NCT00207818

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 I Phase II

U.S. FDA Resources

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

Further study details as provided by Centre Hospitalier Affilie, Universitaire de Quebec:

Primary Outcome Measures:

wound closure

Secondary Outcome Measures:

% of healing at 6 months of treatment

Estimated Enrollment:	6
Study Start Date:	September 1999

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:

Men or women from 18 to 85 years old
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

Contacts

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

Locations

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

Sponsors and Collaborators

Centre Hospitalier Affilie, Universitaire de Quebec

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

LOEX research laboratory website This link exits the ClinicalTrials.gov site

Publications:

Pouliot R, Larouche D, Auger FA, Juhasz J, Xu W, Li H, Germain L. Reconstructed human skin produced in vitro and grafted on athymic mice. Transplantation. 2002 Jun 15;73(11):1751-7.

Michel M, L'Heureux N, Pouliot R, Xu W, Auger FA, Germain L. Characterization of a new tissue-engineered human skin equivalent with hair. In Vitro Cell Dev Biol Anim. 1999 Jun;35(6):318-26.

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

Keywords provided by Centre Hospitalier Affilie, Universitaire de Quebec:

tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care

Study placed in the following topic categories:

Varicose Ulcer
Varicose Veins
Skin Diseases
Ulcer

Vascular Diseases
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009