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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.

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
NameTimeMethod
Product Performance
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (10)

Institute for Advanced Wound Care

🇺🇸

Montgomery, Alabama, United States

Center for Clinical Research, Inc.

🇺🇸

Castro Valley, California, United States

Gwinnet Hospital System

🇺🇸

Lawrenceville, Georgia, United States

Wound Healing and Treatment Center - Silver Cross Hospital

🇺🇸

Joliet, Illinois, United States

Wound Healing Center

🇺🇸

Terre Haute, Indiana, United States

Dermatology Clinic - Montreal General Hospital

🇨🇦

Montreal, Quebec, Canada

Dermatology Clinic

🇨🇦

Mississauga, Ontario, Canada

Wound Healing Research Unit

🇬🇧

Cardiff, United Kingdom

Grantham & District Hospital

🇬🇧

Grantham, United Kingdom

Clayponds Hospital

🇬🇧

London, United Kingdom

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

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