Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers
NCT ID: NCT00558662
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
234 participants
INTERVENTIONAL
2007-11-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Coban 2 Layer Compression System
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
Short-Stretch Bandage
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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 with known allergies against the following products: Coban 2 Layer Compression System, Rosidal K, Rosidal soft, Tegaderm Foam, Cavilon NSBF
18 Years
ALL
No
Sponsors
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3M
INDUSTRY
Solventum US LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Wolfgang Vanscheidt, Prof MD PhD
Role: STUDY_CHAIR
Eberhard Rabe, Prof. MD PhD
Role: PRINCIPAL_INVESTIGATOR
Klnik und Poliklinik für Dermatologie der Universität Bonn
Joachim Dissemond, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinik Essen
Markus Stücker, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Klinik für Dermatologie der Rhur Universität Bochum
Keith Harding, MB, MRCGP, FRCS
Role: PRINCIPAL_INVESTIGATOR
Wound Healing Research Unit
Jost van der Kleij, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Atrium Medisch Centrum Parkstad in Heerlen
Karl-Heinz Konz, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Kliniken Maria Hilf Mönchengladbach
Jose Schroijen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Dermatology, Ziekenhuis de Lievensberg
Dinanda Kolbach, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Dr. Kolbach Kliniek
Karin Timm
Role: PRINCIPAL_INVESTIGATOR
IJsselland Hospital
Gill Wicks
Role: PRINCIPAL_INVESTIGATOR
Tissue Viability
Sylvie Hampton, MA BSc (Hons) DpSN RGN
Role: PRINCIPAL_INVESTIGATOR
Tissue Viability
Helger Stege, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Lippe-Lemgo
Rik Couvreur, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Military Hospital Queen Astrid
Toon Sabbe, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AZ alma Eeklo
Rudi Vossaert, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wound Centre AZ St. Elisabeth
Locations
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Wound Centre AZ St. Elisabeth
Zottegem, Godveerdegemstraat 69, Belgium
AZ Alma Eeklo
Eeklo, Moeie 13, Belgium
Military Hospital Queen Astrid
Brussels, Neder-Over-Heembeek, Belgium
Klinik für Dermatologie der Rhr Universität Bochum - Venenzentrum der dermatologischen und gefäßchirurgischen Kliniken
Bochum, , Germany
Klinik und Poliklinik für Dermatologie der Universität Bonn
Bonn, , Germany
Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Essen, , Germany
Prof. Vanscheidt, MD, PhD
Freiburg im Breisgau, , Germany
Klinikum Lippe_lemgo
Lemgo, , Germany
Kliniken Maria Hilf
Mönchengladbach, , Germany
Ziekenhuis de Lievensberg, Department of Dermatology
Bergen op Zoom, , Netherlands
IJsselland Hospital
Capelle aan den IJssel, , Netherlands
Atrium Medisch Centrum Parkstad in Heerlen
Heerlen, , Netherlands
Dr. Kolbach Kliniek
Maastricht, , Netherlands
Wound Healing Research unit, Cardiff Medicentre
Cardiff, , United Kingdom
Tissue Viability
Eastbourne, , United Kingdom
Trowbridge Community Hospital
Trowbridge, , United Kingdom
Countries
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Other Identifiers
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EU Study No-05-000003
Identifier Type: -
Identifier Source: org_study_id
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