A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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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
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Wound Heal

Intervention / Treatment
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* Device: Biatain Ag
* Device: Cutimed Siltec Sorbact


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has signed informed consent Is above 18 years of age and has full legal capacity Has venous leg ulcer (C6 of the CEAP classification) with a duration longer than 8 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 Heat Oedema, induration or swelling Spontaneous pain or pressure pain Stalled wound healing Increase and/or change of color of exudate Increase and/or change of smell of exudate Has wound area of min 2x2 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 2 weeks before inclusion Has been receiving the following medical treatment within the last 4 weeks: corticoids, immunosuppression, immunomodulating medication or cytostatic 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biatain Ag<br> | Device: Biatain Ag<br>* Biatain with silver<br>|
| Active Comparator: Cutimed Siltec Sorbact<br> | Device: Cutimed Siltec Sorbact<br>* comparator device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Relative wound area change measured by calculation of area based on photo of wound | After 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound area reduction | Reaching ≥ 40% wound area change | After 4 weeks | 
| Wound healing | Wounds healed after 12 weeks (yes/no assessed by investigator) | After 12 weeks | 
| Quality of Life (based on Wound-Quality of Life-17 questionnaire) | Patient Quality of Life | After 4 and 12 weeks |