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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ClinicalTrials.gov Identifier:

NCT00558662

First received: November 13, 2007

Last updated: November 17, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 13, 2007

Last Updated Date

November 17, 2011

Start Date ^ICMJE

November 2007

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00558662 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- 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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Venous Ulcer

Intervention ^ICMJE

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
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

Study Arm (s)

Active Comparator: 1
Coban 2 Layer Compression System

Intervention: Device: Coban 2
Active Comparator: 2
Short-Stretch Bandage

Intervention: Device: SSB

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

234

Completion Date

September 2011

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Germany, Netherlands, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00558662

Other Study ID Numbers ^ICMJE

EU Study No-05-000003

Has Data Monitoring Committee

Yes

Responsible Party

Study Sponsor ^ICMJE

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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