Treatment of Cutaneous Ulcers With a Novel Biological Dressing

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by Centre Hospitalier Affilie, Universitaire de Quebec. Recruitment status was Recruiting

First Received on September 13, 2005. No Changes Posted

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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 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

Additional 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.

ClinicalTrials.gov Identifier:	NCT00207818 History of Changes
Other Study ID Numbers:	LOEX 005, 29478 Health Canada
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
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

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 February 12, 2012