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

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.

Completed

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Key information

Conditions

Venous Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology Clinic - Montreal General Hospital, Montreal, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

venous leg ulcer
patient can walk

Exclusion criteria

cancerous ulcers
diabetic foot ulcer

Treatment and study plan

Coban 2 Layer Compression System

Device

Primary outcomes

Product Performance

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

Registry information

Official study 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

Important dates

Study start: 2006
Study completion: 2007
First posted: Mar 13, 2006
Registry last updated: Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed