Venous Ulcer
Conditions
Keywords
compression therapy, venous leg ulcer, sub bandage pressure
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.
Interventions
DEVICECoban 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.
DEVICESSB
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.
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - venous leg ulcer healing | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| - wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE | 12 weeks |
Countries
Belgium, Germany, Netherlands, United Kingdom
Outcome results
None listed