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

March 10, 2006
October 10, 2007
March 2006
Not Provided
Product Performance
Same as current
Complete list of historical versions of study NCT00301496 on ClinicalTrials.gov Archive Site
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Randomized Controlled 8-Week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Ulcer
Device: Coban 2 Layer Compression System
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
April 2007
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Inclusion Criteria:

  • venous leg ulcer
  • patient can walk

Exclusion Criteria:

  • cancerous ulcers
  • diabetic foot ulcer
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   United Kingdom
 
NCT00301496
05-010302
Not Provided
Not Provided
3M
Not Provided
Principal Investigator: Christine Moffatt, PhD, MA, RGN Centre for Research and Implementation of Clinical Practice
3M
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP