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

Randomized Controlled Clinical Study to Assess the Clinical Efficacy of the 3M™ Coban™ 2 Layer Compression System Compared to a Short-stretch Compression Bandage in the Treatment of Venous Leg Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Venous Ulcer
• Intervention / Treatment: Device: Coban 2; Device: SSB

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Godveerdegemstraat 69
    • Zottegem, Godveerdegemstraat 69, Belgium, 9620
      • Wound Centre AZ St. Elisabeth
  • Moeie 13
    • Eeklo, Moeie 13, Belgium, 9900
      • AZ Alma Eeklo
  • Neder-Over-Heembeek
    • Brussels, Neder-Over-Heembeek, Belgium, 1120
      • Military Hospital Queen Astrid
• Germany
  • Bochum, Germany, 44805
    • Klinik für Dermatologie der Rhr Universität Bochum - Venenzentrum der dermatologischen und gefäßchirurgischen Kliniken
  • Bonn, Germany, 53105
    • Klinik und Poliklinik für Dermatologie der Universität Bonn
  • Essen, Germany, 45147
    • Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
  • Freiburg, Germany, 79102
    • Prof. Vanscheidt, MD, PhD
  • Lemgo, Germany, 32657
    • Klinikum Lippe_lemgo
  • Mönchengladbach, Germany, 41069
    • Kliniken Maria Hilf
• Netherlands
  • Bergen op Zoom, Netherlands, 4600AC
    • Ziekenhuis de Lievensberg, Department of Dermatology
  • Capelle aan den IJssel, Netherlands, 2906
    • Ijsselland Hospital
  • Heerlen, Netherlands, 6419
    • Atrium Medisch Centrum Parkstad in Heerlen
  • Maastricht, Netherlands, 6218
    • Dr. Kolbach Kliniek
• United Kingdom
  • Cardiff, United Kingdom, CF14 4UJ
    • Wound Healing Research unit, Cardiff Medicentre
  • Eastbourne, United Kingdom, BN21 4RL
    • Tissue Viability
  • Trowbridge, United Kingdom
    • Trowbridge Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males or females, age 18 years or older
• Subjects having a venous leg ulcer (stage C6 according CEAP classification, venous pathology proved by the presence of reflux (Pr)), which is at least 1 cm in any dimension but not larger than 10 cm in any dimension and has at least 5 cm distance to additional ulcers.
• Subjects who are co-operative, willing to give written informed consent prior to study entry, and willing to comply with the study protocol.
• Subjects who are able to understand and answer questionnaire items.
• Subjects who can walk (with or without a walking aid).
• Subjects who have an ABPI (ankle brachial pressure index) of treated leg greater or equal to 0,8 as measured within four weeks prior to enrollment.
• Subjects with venous incompetence as defined by reflux longer than 1,0 second in at least one of the following sites: groin [femoral vein, junction of GSV], mid thigh medial [GSV], hollow of the knee [popliteal vein, junction of SSV], mid calf [SSV] in the standing position, measured by Doppler, preferably by duplex within the last 12 month without following active treatment of venous reflux.

Exclusion Criteria:

• Subjects with an ABPI < 0.8 as measured within four weeks prior to enrollment.
• Subjects whose condition, in the opinion of the investigator, does not require or allow for compression therapy.
• Subjects where the potential study ulcer is infected, i.e. showing signs of clinical infection (not contamination) as evidenced by purulent, malodorous, or recent increase in drainage and/or peri-wound erythema or elevated temperature.
• Subjects receiving any systemic antibiotics.
• Subjects with diagnosed cancerous ulceration.
• Subjects with diabetic foot ulcers (do not exclude diabetics).
• Subjects with circumferential wounds.
• Subjects who started or significantly changed treatment with mood altering substances (e.g. antidepressant drugs) within two weeks prior to enrollment.
• Subjects who are participating in any prospective clinical study that can potentially interfere with this study.
• Subjects who are, in the opinion of the clinical investigator, unsuitable for enrollment in this study, for reasons not specified in the exclusion criteria.
• Subjects with known allergies against the following products: Coban 2 Layer Compression System, Rosidal K, Rosidal soft, Tegaderm Foam, Cavilon NSBF

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Coban 2 Layer Compression System	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.; Other Names: Coban 2 Layer Compression System
Active Comparator: 2; Short-Stretch Bandage	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.; Other Names: Rosidal K; Rosidal soft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
- venous leg ulcer healing	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
- wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE	12 weeks

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M
• Investigators: Study Chair: Wolfgang Vanscheidt, Prof MD PhD; Principal Investigator: Eberhard Rabe, Prof. MD PhD, Klnik und Poliklinik für Dermatologie der Universität Bonn; Principal Investigator: Joachim Dissemond, MD PhD, Universitatsklinik Essen; Principal Investigator: Markus Stücker, MD PhD, Klinik für Dermatologie der Rhur Universität Bochum; Principal Investigator: Keith Harding, MB, MRCGP, FRCS, Wound Healing Research Unit; Principal Investigator: Jost van der Kleij, MD, PhD, Atrium Medisch Centrum Parkstad in Heerlen; Principal Investigator: Karl-Heinz Konz, MD PhD, Kliniken Maria Hilf Mönchengladbach; Principal Investigator: Jose Schroijen, MD PhD, Department of Dermatology, Ziekenhuis de Lievensberg; Principal Investigator: Dinanda Kolbach, MD PhD, Dr. Kolbach Kliniek; Principal Investigator: Karin Timm, Ijsselland Hospital; Principal Investigator: Gill Wicks, Tissue Viability; Principal Investigator: Sylvie Hampton, MA BSc (Hons) DpSN RGN, Tissue Viability; Principal Investigator: Helger Stege, MD PhD, Klinikum Lippe-Lemgo; Principal Investigator: Rik Couvreur, MD, PhD, Military Hospital Queen Astrid; Principal Investigator: Toon Sabbe, MD, PhD, AZ Alma Eeklo; Principal Investigator: Rudi Vossaert, MD, PhD, Wound Centre AZ St. Elisabeth

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: November 13, 2007
• First Submitted That Met QC Criteria: November 14, 2007
• First Posted (Estimated): November 15, 2007

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: compression therapy; venous leg ulcer; sub bandage pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Membrane Transport Modulators; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Ionophores; Coccidiostats; Proton Ionophores; Uncoupling Agents; Sodium Ionophores; Monensin
• Other Study ID Numbers: EU Study No-05-000003