NCT01084577已完成4 期
A Prospective, Multi-centre, Randomized, Open-label, Parallel, Comparative Study to Evaluate Effects of AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 56
- 主要终点
- Wound area reduction from baseline (relative)
研究概览
简要总结
A prospective, comparative, randomised study to compare the effects on ulcer healing of AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.
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
- •Subjects over 18 years, willing and able to provide written informed consent.
- •Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater.
- •Subjects who have a venous leg ulcer (i.e. CEAP classification of C6), with duration less than 24 months and size ranging between 5 cm2-40 cm2 .
- •Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs: pain between 2 dressing changes, perilesional skin erythema, oedema, foul odour, and heavy exudation.
- •Subjects agree to wear compression therapy daily in combination with the trial dressing.
排除标准
- •Subjects with a history of skin sensitivity to any of the components of the study product.
- •Subjects who have had current local or systemic antibiotics in the week prior to inclusion.
- •Subjects whose leg ulcers are clinically infected or erysipelas, malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
- •Subjects who have a progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents or high dose corticosteroids.
- •Subjects who have participated in a clinical study within the past 3 months.
- •Subjects who are pregnant or breastfeeding (in accordance with the Urgotul® Silver package insert).
研究组 & 干预措施
Urgotul® Silver
Active Comparator
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
干预措施: Urgotul® Silver (Device)
AQUACEL® Ag
Active Comparator
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
干预措施: AQUACEL® Ag (Device)
结局指标
主要结局
Wound area reduction from baseline (relative)
时间窗: 8 weeks
次要结局
- Wound closure(8 weeks)
- Clinical evolution of the wound(8 weeks)
- Tolerance(8 weeks)
研究者
研究点 (56)
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