NCT05923749CompletedNot Applicable
A Prospective Randomised Controlled Study Demonstrating the Clinical Benefit of Biatain® Ag Relative to Cutimed® Siltec® Sorbact® for the Treatment of Venous Leg Ulcers
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 180
- Locations
- 26
- Primary Endpoint
- Wound healing
Study Overview
Brief Summary
Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has signed informed consent
- •Is above 18 years of age or above and has full legal capacity
- •Has venous leg ulcer (C6 of the CEAP classification) with a duration longer than 4 weeks but no longer than 5 years
- •Has acceptance of compression bandages
- •Has a wound at risk of infection based on WAR (wounds at risk of infection) score with score of ≥3 points OR has at least three of the following clinical signs of bacterial contamination based on the Therapeutic index for local infections (TILI) score:
- •Erythema to surrounding skin
- •Oedema, induration or swelling
- •Spontaneous pain or pressure pain
- •Stalled wound healing
- •Increase and/or change of color or smell of exudate
- •Has wound area of min 1x1 cm and max 10x10 cm
- •Has wound with depth of max 2 cm
- •Has wound with medium to high level of exudate (but should not require more than 1 dressing change/day)
- •Has ankle-brachial pressure (ABI) ≥0.8 AND, for patients with diabetes mellitus, additional biphasic Doppler signal up to the ankle
- •Ability (assessed by the investigator) and willingness to adhere to a 1-month intervention period
- •For patients with diabetes, has HbA1c ≤ 10%/≤ 86 mmol/mol, measured within the last 3 months prior to inclusion
- •Should be able to follow the study protocol with the prescribed cleansing product (NaCl) and dressing
Exclusion Criteria
- •Is pregnant or breastfeeding
- •Has wounds with exposed tendons, bones, fistulas. Or wounds with cavity, undermined or tunnelling
- •Has infection requiring antibiotics (also for other reasons than wound infection) OR has received antibiotics within the last 1 week before inclusion
- •Has been receiving the following medical treatment within the last 4 weeks: immunosup-pression, immunomodulating, cytostatic medi-cation or corticoids (topical except for in the wound, inhalation, and stable systemic treat-ment up to 5 mg per day (stable defined as minimum 4 weeks) is allowed
- •Has a systemic hematological disease
- •Has renal insufficiency requiring dialysis
- •Has advanced heart failure NYHA III/IV
- •Has a psychiatric illness that inhibits compliance with the study protocol
- •Has severe congenital immunodeficiency such agammaglobulinemia, severe combined immunodeficiency (SCID)
- •Has allergy towards silver or other dressing ingredients (including compression therapy)
- •Has wound with > 50% necrotic tissue
- •Treatment of wound with an anti-microbial wound dressing within the last 2 weeks
Outcomes
Primary Outcomes
Wound healing
Time Frame: After 4 weeks
Relative wound area change measured by calculation of area based on photo of wound
Secondary Outcomes
- Wound area reduction(After 4 weeks)
- Quality of Life (based on Wound-Quality of Life-17 questionnaire)(After 4 and 12 weeks)
- Wound healing(After 12 weeks)
Investigators
Study Sites (26)
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