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Treatment of Cutaneous Ulcers With a Novel Biological Dressing

Primary Purpose

Venous Ulcers

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
self assembled skin substitute (SASS)
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Ulcers focused on measuring tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre hospitalier affilie universitaire de Quebec

Outcomes

Primary Outcome Measures

wound closure

Secondary Outcome Measures

% of healing at 6 months of treatment

Full Information

First Posted
September 13, 2005
Last Updated
February 10, 2014
Sponsor
CHU de Quebec-Universite Laval
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1. Study Identification

Unique Protocol Identification Number
NCT00207818
Brief Title
Treatment of Cutaneous Ulcers With a Novel Biological Dressing
Official Title
Treatment of Cutaneous Ulcers With a Novel Biological Dressing
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcers
Keywords
tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
self assembled skin substitute (SASS)
Intervention Description
Wound care with self assembled skin substitute (SASS)
Primary Outcome Measure Information:
Title
wound closure
Secondary Outcome Measure Information:
Title
% of healing at 6 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois A Auger, MD
Organizational Affiliation
Centre hospitalier affilié universitaire de Québec
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucie Germain, Ph.D.
Organizational Affiliation
Centre hospitalier affilié universitaire de Québec
Official's Role
Study Director
Facility Information:
Facility Name
Centre hospitalier affilie universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12084997
Citation
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. doi: 10.1097/00007890-200206150-00010.
Results Reference
background
PubMed Identifier
10476918
Citation
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. doi: 10.1007/s11626-999-0081-x.
Results Reference
background
Links:
URL
http://www.loex.qc.ca
Description
LOEX research laboratory website

Learn more about this trial

Treatment of Cutaneous Ulcers With a Novel Biological Dressing

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