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

NCT00558662 | Completed DMC

• 1 other identifier: EU Study No-05-000003
• Study Type: interventional
• Target: 234
• Locations: 4 countries
• Sites: 16

Brief 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

Keywords

compression therapy; venous leg ulcer; sub bandage pressure

Outcome Measures

Primary Outcomes (1)

• - venous leg ulcer healing

  12 weeks

Secondary Outcomes (1)

• - wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE

  12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Coban 2 Layer Compression System

Device: Coban 2

2

ACTIVE COMPARATOR

Short-Stretch Bandage

Device: SSB

Interventions

Coban 2 DEVICE

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.

Also known as: Coban 2 Layer Compression System

1

SSB DEVICE

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.

Also known as: Rosidal K, Rosidal soft

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 with known allergies against the following products: Coban 2 Layer Compression System, Rosidal K, Rosidal soft, Tegaderm Foam, Cavilon NSBF

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (16)

Wound Centre AZ St. Elisabeth

Zottegem, Godveerdegemstraat 69, 9620, Belgium

Location

AZ Alma Eeklo

Eeklo, Moeie 13, 9900, Belgium

Location

Military Hospital Queen Astrid

Brussels, Neder-Over-Heembeek, 1120, Belgium

Location

Klinik für Dermatologie der Rhr Universität Bochum - Venenzentrum der dermatologischen und gefäßchirurgischen Kliniken

Bochum, 44805, Germany

Location

Klinik und Poliklinik für Dermatologie der Universität Bonn

Bonn, 53105, Germany

Location

Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

Essen, 45147, Germany

Location

Prof. Vanscheidt, MD, PhD

Freiburg im Breisgau, 79102, Germany

Location

Klinikum Lippe_lemgo

Lemgo, 32657, Germany

Location

Kliniken Maria Hilf

Mönchengladbach, 41069, Germany

Location

Ziekenhuis de Lievensberg, Department of Dermatology

Bergen op Zoom, 4600AC, Netherlands

Location

IJsselland Hospital

Capelle aan den IJssel, 2906, Netherlands

Location

Atrium Medisch Centrum Parkstad in Heerlen

Heerlen, 6419, Netherlands

Location

Dr. Kolbach Kliniek

Maastricht, 6218, Netherlands

Location

Wound Healing Research unit, Cardiff Medicentre

Cardiff, CF14 4UJ, United Kingdom

Location

Tissue Viability

Eastbourne, BN21 4RL, United Kingdom

Location

Trowbridge Community Hospital

Trowbridge, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

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

Study Officials

• Wolfgang Vanscheidt, Prof MD PhD

  STUDY CHAIR

• Eberhard Rabe, Prof. MD PhD

  Klnik und Poliklinik für Dermatologie der Universität Bonn

  PRINCIPAL INVESTIGATOR

• Joachim Dissemond, MD PhD

  Universitätsklinik 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 15, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: September 1, 2011
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

DE (6); GB (3); BE (3); NL (4)