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

Solventum US LLC

Status: Completed

Conditions: Venous Ulcer

Treatments: Device: Coban 2 Layer Compression System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00301496

05-010302

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• venous leg ulcer
• patient can walk

Exclusion criteria

• cancerous ulcers
• diabetic foot ulcer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)