Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers

Summary

The study purpose is to compare healing rates, cost effectiveness, quality of life and safety of 12 week compression therapy for the treatment of venous leg ulcers with the 3M™ Coban™ 2 Layer Compression System versus short-stretch compression bandage.

Conditions

• Venous Ulcer

Interventions

DEVICE

Coban 2

Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.

DEVICE

SSB

Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.

Sponsors & Collaborators

• 3M

  collaborator INDUSTRY

• Solventum US LLC

  lead INDUSTRY

Principal Investigators

• Wolfgang Vanscheidt, Prof MD PhD

• Eberhard Rabe, Prof. MD PhD · Klnik und Poliklinik für Dermatologie der Universität Bonn

• Joachim Dissemond, MD PhD · Universitätsklinik Essen

• Markus Stücker, MD PhD · Klinik für Dermatologie der Rhur Universität Bochum

• Keith Harding, MB, MRCGP, FRCS · Wound Healing Research Unit

• Jost van der Kleij, MD, PhD · Atrium Medisch Centrum Parkstad in Heerlen

• Karl-Heinz Konz, MD PhD · Kliniken Maria Hilf Mönchengladbach

• Jose Schroijen, MD PhD · Department of Dermatology, Ziekenhuis de Lievensberg

• Dinanda Kolbach, MD PhD · Dr. Kolbach Kliniek

• Karin Timm · IJsselland Hospital

• Gill Wicks · Tissue Viability

• Sylvie Hampton, MA BSc (Hons) DpSN RGN · Tissue Viability

• Helger Stege, MD PhD · Klinikum Lippe-Lemgo

• Rik Couvreur, MD, PhD · Military Hospital Queen Astrid

• Toon Sabbe, MD, PhD · AZ alma Eeklo

• Rudi Vossaert, MD, PhD · Wound Centre AZ St. Elisabeth

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2009-04-30

Completion

2011-09-30

Countries

• Belgium
• Germany
• Netherlands
• United Kingdom

Study Locations