NCT00207818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

9.8 years

First QC Date

September 13, 2005

Last Update Submit

February 10, 2014

Conditions

Venous Ulcers

Keywords

tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care

Outcome Measures

Primary Outcomes (1)

  • wound closure

Secondary Outcomes (1)

  • % of healing at 6 months of treatment

Interventions

self assembled skin substitute (SASS)DEVICE

Wound care with self assembled skin substitute (SASS)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women from 18 to 85 years old
  • Have a venous ulcer or a mixed ulcer

You may not qualify if:

  • Diabetes Mental deficiency Hepatitis holder (A-B-C) HIV positive Pregnancy or lactation Corticosteroids therapy Radiotherapy Chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier affilie universitaire de Quebec

Québec, Quebec, G1J 1Z4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 12084997BACKGROUND

  • 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.

    PMID: 10476918BACKGROUND

Related Links

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Francois A Auger, MD

    Centre hospitalier affilié universitaire de Québec

    PRINCIPAL INVESTIGATOR

  • Lucie Germain, Ph.D.

    Centre hospitalier affilié universitaire de Québec

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

September 1, 1999

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

CA(1)