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

Tracking Information
First Submitted Date ICMJE	March 10, 2006
First Posted Date ICMJE	March 13, 2006
Last Update Posted Date	October 11, 2007
Study Start Date ICMJE	March 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: March 10, 2006)	Product Performance
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00301496 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Randomized Controlled 8-Week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers
Official Title ICMJE	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
Brief Summary	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.
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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Venous Ulcer
Intervention ICMJE	Device: Coban 2 Layer Compression System
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: March 10, 2006)	80
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	April 2007
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: venous leg ulcer; patient can walk Exclusion Criteria: cancerous ulcers; diabetic foot ulcer
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, United Kingdom, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00301496
Other Study ID Numbers ICMJE	05-010302
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	3M
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Christine Moffatt, PhD, MA, RGN Centre for Research and Implementation of Clinical Practice
PRS Account	3M
Verification Date	October 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP