Randomized Controlled 8-Week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers

This study has been completed.
Sponsor:
Information provided by:
3M
ClinicalTrials.gov Identifier:
NCT00301496
First received: March 10, 2006
Last updated: October 10, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention
Venous Ulcer
Device: Coban 2 Layer Compression System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by 3M:

Primary Outcome Measures:
  • Product Performance

Estimated Enrollment: 80
Study Start Date: March 2006
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • venous leg ulcer
  • patient can walk

Exclusion Criteria:

  • cancerous ulcers
  • diabetic foot ulcer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301496

Locations
United States, Alabama
Institute for Advanced Wound Care
Montgomery, Alabama, United States, 36111
United States, California
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
United States, Georgia
Gwinnet Hospital System
Lawrenceville, Georgia, United States, 30045
United States, Illinois
Wound Healing and Treatment Center - Silver Cross Hospital
Joliet, Illinois, United States, 60432
United States, Indiana
Wound Healing Center
Terre Haute, Indiana, United States, 47807
Canada, Quebec
Dermatology Clinic - Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Canada
Dermatology Clinic
Mississauga, Ontario, Canada, L4Y 1A6
United Kingdom
Wound Healing Research Unit
Cardiff, United Kingdom
Grantham & District Hospital
Grantham, United Kingdom
Clayponds Hospital
London, United Kingdom
Sponsors and Collaborators
3M
Investigators
Principal Investigator: Christine Moffatt, PhD, MA, RGN Centre for Research and Implementation of Clinical Practice
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00301496     History of Changes
Other Study ID Numbers: 05-010302
Study First Received: March 10, 2006
Last Updated: October 10, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014