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NCT00207818 Clinical Trial

Treatment of Cutaneous Ulcers With a Novel Biological Dressing

Venous Ulcers Clinical Trial

Official title:
Treatment of Cutaneous Ulcers With a Novel Biological Dressing

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00207818
Other study ID # LOEX 005
Secondary ID 29478 Health Can
Status Completed
Phase Phase 1/Phase 2
First received September 13, 2005
Last updated February 10, 2014
Start date September 1999
Est. completion date June 2009

Study information
Verified date February 2014
Source Centre Hospitalier Universitaire de Québec, CHU de Québec
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• self assembled skin substitute (SASS)
Wound care with self assembled skin substitute (SASS)

Locations
Country Name City State
Canada Centre hospitalier affilie universitaire de Quebec Quebec

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary wound closure No
Secondary % of healing at 6 months of treatment No
See also
  Status Clinical Trial Phase
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Completed NCT03070925 - Prospective PuraPly™ AM Case Series Study N/A
Not yet recruiting NCT01491438 - Plasma Rich Growth Factors in Venous Ulcers N/A
Completed NCT01348581 - Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing N/A
Completed NCT02034396 - Clinical Implications of Genetic Variations of Venous Stasis Ulceration N/A
Completed NCT06280053 - HealiAid in the Treatment of Different Wounds N/A
Completed NCT02364921 - Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care N/A
Suspended NCT02930499 - Effect of Hyaluronic Acid ECM on Venous Ulcers N/A
Recruiting NCT06350695 - The ROle of Compression StocKings in Heart Failure Patients N/A
Completed NCT01214980 - Split Thickness Donor Site Healing With MIST Study N/A
Terminated NCT00613808 - Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers Phase 2
Completed NCT04703569 - Effect of Compressive Therapies on the Healing of Venous Ulcers N/A
Completed NCT01509599 - Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation Phase 1/Phase 2
Completed NCT02632695 - Physical Activity Interventions for Leg Ulcer Patients N/A
Terminated NCT02071979 - Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds N/A

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