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NCT00301496 Clinical Trial

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

Venous Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00301496
Other study ID # 05-010302
Secondary ID
Status Completed
Phase N/A
First received March 10, 2006
Last updated October 10, 2007
Start date March 2006
Est. completion date April 2007

Study information
Verified date October 2007
Source 3M
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- venous leg ulcer

- patient can walk

Exclusion Criteria:

- cancerous ulcers

- diabetic foot ulcer

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• Coban 2 Layer Compression System

Locations
Country Name City State
Canada Dermatology Clinic Mississauga, Ontario
Canada Dermatology Clinic - Montreal General Hospital Montreal Quebec
United Kingdom Wound Healing Research Unit Cardiff
United Kingdom Grantham & District Hospital Grantham
United Kingdom Clayponds Hospital London
United States Center for Clinical Research, Inc. Castro Valley California
United States Wound Healing and Treatment Center - Silver Cross Hospital Joliet Illinois
United States Gwinnet Hospital System Lawrenceville Georgia
United States Institute for Advanced Wound Care Montgomery Alabama
United States Wound Healing Center Terre Haute Indiana

Sponsors (1)
Lead Sponsor Collaborator
3M

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Product Performance
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