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

Sponsor:	3M
Information provided by (Responsible Party):	3M
ClinicalTrials.gov Identifier:	NCT00558662

Purpose

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.

Condition	Intervention
Venous Ulcer	Device: Coban 2 Device: SSB

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Leg Injuries and Disorders

Drug Information available for: Monensin Monensin sodium

U.S. FDA Resources

Further study details as provided by 3M:

Primary Outcome Measures:

- venous leg ulcer healing [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

- wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	234
Study Start Date:	November 2007
Study Completion Date:	September 2011
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558662

Locations

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

Sponsors and 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	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

More Information

No publications provided

Responsible Party:	3M
ClinicalTrials.gov Identifier:	NCT00558662 History of Changes
Other Study ID Numbers:	EU Study No-05-000003
Study First Received:	November 13, 2007
Last Updated:	November 17, 2011
Health Authority:	Germany: Ethics Commission; Netherlands: Medical Ethics Review Committee (METC); United Kingdom: Research Ethics Committee

Keywords provided by 3M:

compression therapy
venous leg ulcer
sub bandage pressure

Additional relevant MeSH terms:

Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Monensin

Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012