Evaluation of Efficacy and Safety of the 2-layer Compression System Kit Biflex® Versus the 4-layer Compression System PROFORE® in the Management of Venous Leg Ulcers (Stage C6).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Thuasne
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Percentage of patients with complete wound closure (100% re-epithelialisation) over the treatment period
研究概览
简要总结
The primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks.
详细描述
This trial is a multicentre, randomized, comparative, open label clinical study conducted in vascular medicine centres in France, with 2 parallel groups of 100 patients each. The study will be conducted in patients suffering from venous leg ulcer (stage C6 of the CEAP classification for chronic venous disorders).
The patients will be randomised at the inclusion: they will receive with either Kit Biflex® or the reference device (Profore®) for maximum 16 weeks (or until full healing).
Investigator assessments are planned every 4 weeks +/- 3 days, for 16 weeks.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients or outpatients.
- •Agreeing to wear a multilayer compression system throughout the study period.
- •Presenting with an active venous leg ulcer: Duration between 1-24 months (whether a new ulcer or a recurrent ulcer); Surface area between 2-50 cm2; Venous, superficial or post-thrombotic ulcer confirmed by Doppler ultrasonography (dated within six months).
- •With ankle circumference between 18-25 cm to allow the laying of the compression system.
- •Able to follow the study instructions.
- •Having read the information sheet and dated and signed the informed consent form.
- •Covered by a health insurance system.
排除标准
- •Scheduled surgery for the ulcer during the 16 weeks following inclusion.
- •Clinical superinfected ulcer not controlled oral antibiotics.
- •Malignant ulcer.
- •Ulcer surface totally covered with dry fibrinous tissue or covered with black necrotic plaque on over 10% of its surface.
- •Deep Vein Thrombosis within the last 3 months.
- •Corticosteroids treatment (equivalent to more than 10 mg per day of prednisolone) ongoing or planned during the study.
- •Radiotherapy, chemotherapy or immunosuppressive therapy ongoing or planned during the study.
- •Erysipelas and lymphangitis.
- •Lower extremity arterial disease or microangiopathy (Ankle Brachial Pressure Index <0.8 or> 1.3).
- •Uncontrolled non-insulin dependent diabetes (HbA1c> 8%).
- •Insulin-dependent diabetes.
- •Confined to bed.
- •With any uncontrolled severe and progressive disease.
- •With a known or suspected hypersensitivity to any of the components of the study devices.
- •Who had participated in a previous clinical study within the past 3 months.
- •Pregnant women.
研究组 & 干预措施
Kit Biflex
The Kit Biflex® will be applied according to manufacturer recommendations for 16 weeks or until full healing.
干预措施: Kit Biflex (Device)
Profore
The compression system Profore will be applied according to manufacturer recommendations for 16 weeks or until full healing.
干预措施: Profore (Device)
结局指标
主要结局
Percentage of patients with complete wound closure (100% re-epithelialisation) over the treatment period
时间窗: 16 weeks
Nature and frequency of adverse events
时间窗: 16 weeks
次要结局
未报告次要终点