Treatment of Cutaneous Ulcers With a Novel Biological Dressing

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.

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Key information

Conditions

Venous Ulcers Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre hospitalier affilie universitaire de Quebec

Québec, Quebec, G1J 1Z4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self assembled skin substitute (SASS)

Device

Wound care with self assembled skin substitute (SASS)

Primary outcomes

wound closure

Secondary outcomes

% of healing at 6 months of treatment

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Important dates

Study start: 1999
Primary completion: 2009
Study completion: 2009
First posted: Sep 21, 2005
Registry last updated: Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed