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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Coban 2 Layer Compression System |
|
| 2 | Active Comparator | Short-Stretch Bandage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coban 2 | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| - venous leg ulcer healing | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| - wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Vanscheidt, Prof MD PhD | Study Chair | |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wound Centre AZ St. Elisabeth | Zottegem | Godveerdegemstraat 69 | 9620 | Belgium | ||
| AZ Alma Eeklo |
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|
| SSB | Device | 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. |
|
|
| 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 | Principal Investigator |
| Eeklo |
| Moeie 13 |
| 9900 |
| Belgium |
| Military Hospital Queen Astrid | Brussels | Neder-Over-Heembeek | 1120 | Belgium |
| Klinik für Dermatologie der Rhr Universität Bochum - Venenzentrum der dermatologischen und gefäßchirurgischen Kliniken | Bochum | 44805 | Germany |
| Klinik und Poliklinik für Dermatologie der Universität Bonn | Bonn | 53105 | Germany |
| Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie | Essen | 45147 | Germany |
| Prof. Vanscheidt, MD, PhD | Freiburg im Breisgau | 79102 | Germany |
| Klinikum Lippe_lemgo | Lemgo | 32657 | Germany |
| Kliniken Maria Hilf | Mönchengladbach | 41069 | Germany |
| Ziekenhuis de Lievensberg, Department of Dermatology | Bergen op Zoom | 4600AC | Netherlands |
| IJsselland Hospital | Capelle aan den IJssel | 2906 | Netherlands |
| Atrium Medisch Centrum Parkstad in Heerlen | Heerlen | 6419 | Netherlands |
| Dr. Kolbach Kliniek | Maastricht | 6218 | Netherlands |
| Wound Healing Research unit, Cardiff Medicentre | Cardiff | CF14 4UJ | United Kingdom |
| Tissue Viability | Eastbourne | BN21 4RL | United Kingdom |
| Trowbridge Community Hospital | Trowbridge | United Kingdom |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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