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

Solventum US LLC

Status

Completed

Conditions

Venous Ulcer

Treatments

Device: SSB

Device: Coban 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT00558662

EU Study No-05-000003

Details and patient eligibility

About

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.

Enrollment

234 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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