| 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
|
| |
| |
| 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 |
|
|
| 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 |