- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00301496
Randomized Controlled 8-Week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers
October 10, 2007 updated by: 3M
Randomized Controlled Eight Week Cross-Over Clinical Evaluation of the 3M Coban 2-Layer Compression System to Evaluate the Product Performance in Patients With Venous Leg Ulcers
The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers.
The new bandage is a 2-layer compression system.
It will be used over primary dressings to provide the compression that is beneficial to venous leg ulcers.
Study Type
Interventional
Enrollment
80
Phase
- Not Applicable
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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Mississauga, Ontario, Canada, L4Y 1A6
- Dermatology Clinic
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- Dermatology Clinic - Montreal General Hospital
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Cardiff, United Kingdom
- Wound Healing Research Unit
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Grantham, United Kingdom
- Grantham & District Hospital
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London, United Kingdom
- Clayponds Hospital
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Alabama
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Montgomery, Alabama, United States, 36111
- Institute for Advanced Wound Care
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California
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Castro Valley, California, United States, 94546
- Center for Clinical Research, Inc.
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Georgia
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Lawrenceville, Georgia, United States, 30045
- Gwinnet Hospital System
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Illinois
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Joliet, Illinois, United States, 60432
- Wound Healing and Treatment Center - Silver Cross Hospital
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Indiana
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Terre Haute, Indiana, United States, 47807
- Wound Healing Center
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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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- venous leg ulcer
- patient can walk
Exclusion Criteria:
- cancerous ulcers
- diabetic foot ulcer
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Product Performance
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christine Moffatt, PhD, MA, RGN, Centre for Research and Implementation of Clinical Practice
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
March 1, 2006
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
March 10, 2006
First Submitted That Met QC Criteria
March 10, 2006
First Posted (Estimate)
March 13, 2006
Study Record Updates
Last Update Posted (Estimate)
October 11, 2007
Last Update Submitted That Met QC Criteria
October 10, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-010302
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 Ulcer
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Tactile MedicalCompletedVenous Insufficiency | Venous Leg Ulcer | Chronic Venous Insufficiency | Venous Ulcer | Venous Stasis UlcerUnited 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
-
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
-
Gloucestershire Hospitals NHS Foundation TrustNot yet recruitingLeg Ulcer | Venous Leg Ulcer | Venous Insufficiency of Leg | Venous Ulcer
-
ProMedica Health SystemJobst Vascular InstituteRecruitingVenous Insufficiency | Venous Reflux | Venous Ulcer | Venous DiseaseUnited States
-
Ortec InternationalCompletedVenous Leg Ulcer | Venous Stasis UlcerUnited States
-
Firstkind LtdTerminatedLeg Ulcer | Venous Leg Ulcer | Venous UlcerCanada
-
PolarityTEProfessional Education and Research InstituteCompletedVenous Leg Ulcer | Venous Stasis | Venous Stasis UlcerUnited States
-
DeRoyal Industries, Inc.Royal College of Surgeons, Ireland; Enterprise Ireland; Tyndall National InstituteCompletedVenous Leg Ulcer | Venous Insufficiency of LegIreland
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Chang Gung Memorial HospitalRecruitingVenous Leg Ulcer | Venous Insufficiency of Leg | Venous Occlusion | Contrast Media ReactionTaiwan
Clinical Trials on Coban 2 Layer Compression System
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DeRoyal Industries, Inc.Royal College of Surgeons, Ireland; Enterprise Ireland; Tyndall National InstituteCompletedVenous Leg Ulcer | Venous Insufficiency of LegIreland
-
Tactile MedicalTerminatedVenous Leg UlcerUnited States
-
Systagenix Wound ManagementUnknownVenus Leg UlcersUnited States, Germany, Italy, United Kingdom
-
3MCompletedVenous UlcerBelgium, Germany, Netherlands, United Kingdom
-
Nij Smellinghe HosptialCompleted
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Institute of Technology, SligoSligo General HospitalUnknownLymphedema of Upper Arm
-
MiMedx Group, Inc.Completed
-
Ruhr University of BochumCompleted
-
3MWithdrawnVaricose UlcerUnited States, Canada
-
Luzerner KantonsspitalMedtronic - MITG; Orthofix Inc.Completed