Treatment of Cutaneous Ulcers With a Novel Biological Dressing

Phase 1

Completed

• Conditions: Venous Ulcers

• Registration Number: NCT00207818
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief Summary

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.

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.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
wound closure

Secondary Outcome Measures

Name	Time	Method
% of healing at 6 months of treatment

Trial Locations

Locations (1)

Centre hospitalier affilie universitaire de Quebec; 🇨🇦 Quebec, Canada