Treatment of Cutaneous Ulcers With a Novel Biological Dressing

NCT ID: NCT00207818

Last Updated: 2014-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Venous Ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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self assembled skin substitute (SASS)

Wound care with self assembled skin substitute (SASS)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francois A Auger, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier affilié universitaire de Québec

Lucie Germain, Ph.D.

Role: STUDY_DIRECTOR

Centre hospitalier affilié universitaire de Québec

Locations

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Centre hospitalier affilie universitaire de Quebec

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 12084997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10476918 (View on PubMed)

Related Links

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http://www.loex.qc.ca

LOEX research laboratory website

Other Identifiers

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29478 Health Canada

Identifier Type: -

Identifier Source: secondary_id

LOEX 005

Identifier Type: -

Identifier Source: org_study_id

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