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

Not Applicable

Completed

• Conditions: Venous Ulcer
• Interventions: Device: Coban 2; Device: SSB

• Registration Number: NCT00558662
• Lead Sponsor: Solventum US LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-13
• Study First Submitted QC: 2007-11-14
• Study First Posted: 2007-11-15
• Primary Completion: 2009-04
• Study Completion: 2011-09
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Coban 2	Coban 2 Layer Compression System
2	SSB	Short-Stretch Bandage

Primary Outcome Measures

Name	Time	Method
- venous leg ulcer healing	12 weeks

Secondary Outcome Measures

Name	Time	Method
- wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE	12 weeks

Trial Locations

Locations (16)

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, Germany

Klinikum Lippe_lemgo; 🇩🇪 Lemgo, Germany

Kliniken Maria Hilf; 🇩🇪 Mönchengladbach, Germany

Ziekenhuis de Lievensberg, Department of Dermatology; 🇳🇱 Bergen op Zoom, Netherlands

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