- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00207818
Treatment of Cutaneous Ulcers With a Novel Biological Dressing
February 10, 2014 updated by: CHU de Quebec-Universite Laval
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada, G1J 1Z4
- Centre hospitalier affilié universitaire de Québec
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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wound closure
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Secondary Outcome Measures
Outcome Measure |
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% of healing at 6 months of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francois A Auger, MD, Centre hospitalier affilié universitaire de Québec
- Study Director: Lucie Germain, Ph.D., Centre hospitalier affilié universitaire de Québec
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1999
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
February 11, 2014
Last Update Submitted That Met QC Criteria
February 10, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOEX 005
- 29478 Health Canada
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Venous Ulcers
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HealthpointCompletedVenous Leg Ulcer | Venous Stasis UlcersUnited States, Canada
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W.L.Gore & AssociatesRecruitingVenous Leg Ulcer | Venous Stasis | Venous Stenosis | Venous Occlusion | Venous Ulcer | Venous Thromboses | Venous Disease | Vein Thrombosis | Vein Occlusion | Vein DiseaseUnited States
-
W.L.Gore & AssociatesRecruitingVenous Leg Ulcer | Venous Stasis | Venous Stenosis | Venous Occlusion | Venous Ulcer | Venous Thromboses | Venous Disease | Vein Thrombosis | Vein Occlusion | Vein DiseaseUnited States, Australia, Germany, Italy, United Kingdom, New Zealand, Ireland
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DeRoyal Industries, Inc.Royal College of Surgeons, Ireland; Enterprise Ireland; Tyndall National InstituteCompletedVenous Leg Ulcer | Venous Insufficiency of LegIreland
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Firstkind LtdCompletedLeg Ulcer | Venous Leg Ulcer | Wound | Wound Leg | Leg Ulcers VenousUnited Kingdom
-
Gloucestershire Hospitals NHS Foundation TrustNot yet recruitingLeg Ulcer | Venous Leg Ulcer | Venous Insufficiency of Leg | Venous Ulcer
-
Tactile MedicalCompletedVenous Insufficiency | Venous Leg Ulcer | Chronic Venous Insufficiency | Venous Ulcer | Venous Stasis UlcerUnited States
-
Mansoura UniversityActive, not recruitingVaricose Veins | Venous Insufficiency | Venous Leg Ulcer | Venous RefluxEgypt
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University of TurkuUnknown
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Chang Gung Memorial HospitalRecruitingVenous Leg Ulcer | Venous Insufficiency of Leg | Venous Occlusion | Contrast Media ReactionTaiwan
Clinical Trials on self assembled skin substitute (SASS)
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CHU de Quebec-Universite LavalRecruiting
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SymateseUnknownThird-degree Burns | Reconstructive SurgeryFrance
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Medical University of ViennaCompletedWound Healing | Scar FormationAustria
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Professional Education and Research InstituteMusculoskeletal Transplant FoundationCompletedDiabetic Foot UlcerUnited States
-
Chantal BlokZonMw: The Netherlands Organisation for Health Research and DevelopmentTerminated
-
Amarantus BioScience Holdings, Inc.Amarex Clinical ResearchUnknownThermal Injury | Deep Partial-Thickness Burn | Full-Thickness BurnUnited States
-
Euro Tissue BankDutch Burns FoundationTerminatedFull-thickness Skin Loss Due to Burn, Unspecified SiteSpain, Netherlands, Belgium, Greece
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Acera Surgical, Inc.Active, not recruitingDiabetic Foot Ulcer | Venous Leg UlcerUnited States
-
Northwestern UniversityCompletedMelanomaUnited States
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OHSU Knight Cancer InstituteOregon Health and Science UniversityNot yet recruiting