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Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers
This study is currently recruiting participants.
Study NCT00558662   Information provided by 3M
First Received: November 13, 2007   Last Updated: August 26, 2009   History of Changes

November 13, 2007
August 26, 2009
November 2007
April 2009   (final data collection date for primary outcome measure)
- venous leg ulcer healing [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- venous leg ulcer healing [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00558662 on ClinicalTrials.gov Archive Site
- 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 ]
- wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE [ Time Frame: 12 weeks ]
 
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.

 
 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Venous Ulcer
  • Device: Coban 2
  • Device: SSB
  • Active Comparator: Coban 2 Layer Compression System
  • Active Comparator: Short-Stretch Bandage
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Sabine Heiligtag +49 (0) 2131/14 - ext 3464 sheiligtag@mmm.com
Contact: Anja Becker +49 (0) 2131/14 ext 3556 anjabecker@mmm.com
Germany,   Netherlands,   United Kingdom
 
NCT00558662
Sabine Heiligtag, 3M
EU Study No-05-000003
3M
 
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: 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: Ralf U. Peter, Prof. MD PhD HKU GmbH, Blaustein
Principal Investigator: Jose Schroijen, MD PhD Department of Dermatology, Ziekenhuis de Lievensberg
Principal Investigator: O. Q. J. Swinkels, MD PhD Department of Dermatology, Rivierenland Ziekenhuis
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
3M
August 2009

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