Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers

Venous Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00558662
• Other study ID #: EU Study No-05-000003
• Status: Completed
• Phase: N/A
• First received: November 13, 2007
• Last updated: November 17, 2011
• Start date: November 2007
• Est. completion date: September 2011

Study information

• Verified date: March 2011
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionNetherlands: Medical Ethics Review Committee (METC)United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: September 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	Military Hospital Queen Astrid	Brussels	Neder-Over-Heembeek
Belgium	AZ Alma Eeklo	Eeklo	Moeie 13
Belgium	Wound Centre AZ St. Elisabeth	Zottegem	Godveerdegemstraat 69
Germany	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
Germany	Klinikum Lippe_lemgo	Lemgo
Germany	Kliniken Maria Hilf	Mönchengladbach
Netherlands	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
United Kingdom	Wound Healing Research unit, Cardiff Medicentre	Cardiff
United Kingdom	Tissue Viability	Eastbourne
United Kingdom	Trowbridge Community Hospital	Trowbridge

Sponsors (1)

Lead Sponsor	Collaborator
3M

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- venous leg ulcer healing		12 weeks	Yes
Secondary	- wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE		12 weeks	Yes