RCT to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers - Full Text View

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

MedlinePlus related topics:

Leg Injuries and Disorders

ChemIDplus related topics:

Monensin Monensin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by 3M:

Primary Outcome Measures:

- venous leg ulcer healing [ Time Frame: 12 weeks ]

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 ]

Estimated Enrollment:	200
Study Start Date:	November 2007
Estimated Study Completion Date:	April 2008

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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.

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

Contacts


Contact: Christine Bongards, PhD	+49 (0) 2131/14 - ext 4246	cbongards@mmm.com

Locations


Germany
	Prof. Vanscheidt, MD, PhD	Not yet recruiting
	Freiburg, Germany, 79102
	Contact: Wolfgang Vanscheidt, Prof MD PhD +49 - (0) 761- 377950 dermatologie-freiburg@t-online.de
	Principal Investigator: Wolfgang Vanscheidt, Prof MD PhD
	Sub-Investigator: Ukat, MD, PhD
	Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie	Not yet recruiting
	Essen, Germany, 45147
	Contact: Joachim Dissemond, MD, PhD +49 (0) 201-723 ext 3894 joachimdissemond@hotmail.com
	Principal Investigator: Joachim Dissemond, MD, PhD
	Klinik und Poliklinik für Dermatologie der Universität Bonn	Not yet recruiting
	Bonn, Germany, 53105
	Contact: Eberhard Rabe, Prof MD PhD +49 (0) 228 287 1- ext 6232 eberhadr.rabe@ukb.uni-bonn.de
	Sub-Investigator: Annette Ko, MD, PhD
	Principal Investigator: Eberhard Rabe, Prof MD PhD
	Klinik für Dermatologie der Rhr Universität Bochum - Venenzentrum der dermatologischen und gefäßchirurgischen Kliniken	Not yet recruiting
	Bochum, Germany, 44805
	Contact: Markus Stücker, MD, PhD +49 (0) 234 / 87923-77 ext -79 m.stuecker@derma.de
	Principal Investigator: Markus Stuecker, MD PhD

Netherlands
	Atrium Medisch Centrum Parkstad in Heerlen	Not yet recruiting
	Heerlen, Netherlands, 6419
	Contact: Jost van der Kleij, MD PhD +31 (0)45/ 576- ext -7509
	Principal Investigator: Jost van der Kleij, MD PhD
	ERASMUS: Department Dermatology and Venerology	Not yet recruiting
	Rotterdam, Netherlands, 3000
	Principal Investigator: Martino Neumann, Prof MD PhD

United Kingdom
	Wound Healing Research unit, Cardiff Medicentre	Not yet recruiting
	Cardiff, United Kingdom, CF14 4UJ
	Contact: Keith Harding, MD, PhD +44 (0) 2920 682170 harding@cardiff.ac.uk
	Principal Investigator: Keith Harding, MD, PhD
	Vascular Surgery, Bradford Royal Infirmary	Not yet recruiting
	Bradford, United Kingdom, BD9 6RJ
	Contact: Peter Vowden, MD, PhD + 44 (0) 1274-364466 peter.vowden@blueyonder.co.uk
	Principal Investigator: Peter Vowden, Prof MD PhD

Sponsors and Collaborators

3M

Investigators


Study Chair:	Wolfgang Vanscheidt, Prof MD PhD	unaffiliated

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:	Peter Vowden, MD, FRCS	Bradford Royal Infirmary

Principal Investigator:	Jost van der Kleij, MD, PhD	Atrium Medisch Centrum Parkstad in Heerlen

Principal Investigator:	Martino Neumann, Prof MD PhD	ERASMUS Medisch Centrum in Rotterdam

More Information

Study ID Numbers:	EU Study No-05-000003
First Received:	November 13, 2007
Last Updated:	November 14, 2007
ClinicalTrials.gov Identifier:	NCT00558662
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

Study placed in the following topic categories:

Varicose Ulcer

Varicose Veins

Skin Diseases

Clotrimazole

Miconazole

Ulcer

Tioconazole

Vascular Diseases

Skin Ulcer

Monensin

Leg Ulcer

Additional relevant MeSH terms:

Membrane Transport Modulators

Anti-Infective Agents

Antiparasitic Agents

Antiprotozoal Agents

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antifungal Agents

Cardiovascular Diseases

Coccidiostats

Ionophores

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	3M
Information provided by:	3M
ClinicalTrials.gov Identifier:	NCT00558662