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

This study has been completed.

Sponsor:

Information provided by:

ClinicalTrials.gov Identifier:

NCT00301496

First received: March 10, 2006

Last updated: October 10, 2007

Last verified: October 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

March 10, 2006

Last Updated Date

October 10, 2007

Start Date ^ICMJE

March 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Venous Ulcer

Intervention ^ICMJE

Device: Coban 2 Layer Compression System

Study Arm (s)

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

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

Gender

Both

Ages

21 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, Canada, United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00301496

Other Study ID Numbers ^ICMJE

05-010302

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christine Moffatt, PhD, MA, RGN

Centre for Research and Implementation of Clinical Practice

Information Provided By

Verification Date

October 2007

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

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