NCT05923749已完成不适用
A Prospective Randomised Controlled Study Demonstrating the Clinical Benefit of Biatain® Ag Relative to Cutimed® Siltec® Sorbact® for the Treatment of Venous Leg Ulcers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 13
- 主要终点
- Wound healing
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Biatain Ag
Experimental
干预措施: Biatain Ag (Device)
Cutimed Siltec Sorbact
Active Comparator
干预措施: Cutimed Siltec Sorbact (Device)
结局指标
主要结局
Wound healing
时间窗: After 4 weeks
Relative wound area change measured by calculation of area based on photo of wound
次要结局
- 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)
研究者
研究点 (13)
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