EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD: MULTICENTER, PROSPECTIVE, OPEN-LABEL, RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- clinical success at week 4
研究概览
简要总结
Evaluation of the efficacy (reduction of inflammatory signs suggesting a local infection) and tolerance (emergence and nature of adverse event) of Vashe solution vs Saline solution in the treatment of venous or mixed leg ulcers presenting inflammatory signs suggesting heavy bacterial load
详细描述
This study is carried out in United States of America in around 10 investigator sites. A total of 102 patients meeting the eligibility criteria will be included
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
- •Adult patient, at least 18 years of age or older who has provided free, written, and informed consent,
- •Patient who has already worn compression therapy in the past and agrees to wear the two-layer compression system during the whole treatment period,
- •Patient presenting a venous or mixed leg ulcer predominantly of venous origin (ABPI between ≥0.8≤1.3,
- •Leg ulcer presenting at least 3 inflammatory signs (e.g pain, erythema...)
- •Target leg ulcer located at least 3 cm from the edge of another wound.
排除标准
- •Pregnant or breastfeeding patient,
- •Patient already participating in another clinical trial, except observational trial
- •Patient with epifascial arterial bypass (superficial arterial bypass)
- •Patient suffering from phlegmatia coerulea dolens, septic phlebitis, acute deep vein thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated.
- •Patient receiving or having received systemic antibiotics within the ten days prior to inclusion in the investigation, regardless of therapeutic class or indication,
- •Cancerous wound.
研究组 & 干预措施
Vashe solution
Vashe solution is a wound irrigation solution that contain hypochlorous acid
干预措施: Vashe solution (Device)
Saline solution
Saline solution is an isotonic solution designed for irrigation purposes of wounds
干预措施: Saline solution (Device)
结局指标
主要结局
clinical success at week 4
时间窗: week 4
Clinical success at Week 4, defined as a clinical score ≤ 1.
次要结局
未报告次要终点