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

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