Clinical trial NCT00558662: Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Ulcer
Keywords: compression therapy
venous leg ulcer
sub bandage pressure
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2007-11-15
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: - venous leg ulcer healing
timeFrame: 12 weeks
Secondary outcomes:
measure: - wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Zottegem
country: Belgium
facility: Wound Centre AZ St. Elisabeth
state: Godveerdegemstraat 69
city: Eeklo
country: Belgium
facility: AZ Alma Eeklo
state: Moeie 13
city: Brussels
country: Belgium
facility: Military Hospital Queen Astrid
state: Neder-Over-Heembeek
city: Bochum
country: Germany
facility: Klinik für Dermatologie der Rhr Universität Bochum - Venenzentrum der dermatologischen und gefäßchirurgischen Kliniken
city: Bonn
country: Germany
facility: Klinik und Poliklinik für Dermatologie der Universität Bonn
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
city: Freiburg
country: Germany
facility: Prof. Vanscheidt, MD, PhD
city: Lemgo
country: Germany
facility: Klinikum Lippe_lemgo
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf
city: Bergen op Zoom
country: Netherlands
facility: Ziekenhuis de Lievensberg, Department of Dermatology
city: Capelle aan den IJssel
country: Netherlands
facility: IJsselland Hospital
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum Parkstad in Heerlen
city: Maastricht
country: Netherlands
facility: Dr. Kolbach Kliniek
city: Cardiff
country: United Kingdom
facility: Wound Healing Research unit, Cardiff Medicentre
city: Eastbourne
country: United Kingdom
facility: Tissue Viability
city: Trowbridge
country: United Kingdom
facility: Trowbridge Community Hospital
Study officials:
name: Wolfgang Vanscheidt, Prof MD PhD
role: STUDY_CHAIR
affiliation: Klnik und Poliklinik für Dermatologie der Universität Bonn
name: Eberhard Rabe, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinik Essen
name: Joachim Dissemond, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Dermatologie der Rhur Universität Bochum
name: Markus Stücker, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wound Healing Research Unit
name: Keith Harding, MB, MRCGP, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Atrium Medisch Centrum Parkstad in Heerlen
name: Jost van der Kleij, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kliniken Maria Hilf Mönchengladbach
name: Karl-Heinz Konz, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Dermatology, Ziekenhuis de Lievensberg
name: Jose Schroijen, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Kolbach Kliniek
name: Dinanda Kolbach, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IJsselland Hospital
name: Karin Timm
role: PRINCIPAL_INVESTIGATOR
affiliation: Tissue Viability
name: Gill Wicks
role: PRINCIPAL_INVESTIGATOR
affiliation: Tissue Viability
name: Sylvie Hampton, MA BSc (Hons) DpSN RGN
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Lippe-Lemgo
name: Helger Stege, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Military Hospital Queen Astrid
name: Rik Couvreur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ alma Eeklo
name: Toon Sabbe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wound Centre AZ St. Elisabeth
name: Rudi Vossaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: