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

Not Applicable

Completed

• Conditions: Venous Ulcer

• Registration Number: NCT00301496
• Lead Sponsor: Solventum US LLC

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-10
• Study First Submitted QC: 2006-03-10
• Study First Posted: 2006-03-13
• Study Completion: 2007-04
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• venous leg ulcer
• patient can walk

Exclusion Criteria

• cancerous ulcers
• diabetic foot ulcer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Product Performance

Trial Locations

Locations (10)

Dermatology Clinic - Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada

Gwinnet Hospital System; 🇺🇸 Lawrenceville, Georgia, United States

Wound Healing Research Unit; 🇬🇧 Cardiff, United Kingdom

Dermatology Clinic; 🇨🇦 Mississauga, Ontario, Canada

Wound Healing Center; 🇺🇸 Terre Haute, Indiana, United States

Clayponds Hospital; 🇬🇧 London, United Kingdom

Center for Clinical Research, Inc.; 🇺🇸 Castro Valley, California, United States

Institute for Advanced Wound Care; 🇺🇸 Montgomery, Alabama, United States

Wound Healing and Treatment Center - Silver Cross Hospital; 🇺🇸 Joliet, Illinois, United States

Grantham & District Hospital; 🇬🇧 Grantham, United Kingdom