Evaluation of the Efficacy and Safety of Light Compression System Versus Tubular Bandage in the Local Treatment of Mixed Leg Ulcers: a Prospective Open-label RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- Complete closure of the Venous Leg Ulcer (VLU)
研究概览
简要总结
Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of a lite compression system versus a tubular bandage in the local treatment of mixed leg ulcers: prospective multicenter, randomized controlled, open-label french clinical study
详细描述
This is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a mixed (non-ischemic) leg ulcer of stage C6 / C6r of the CEAP classification.
This study is carried out in around 50 French investigational centers. A total of 210 patients meeting the eligibility criteria will be included. The patients will be followed for 16 weeks and a total of 6 clinical evaluations will be carried out by the investigating centers.
A planimetric survey of the studied leg ulcers is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 2, Week 4, Week 8 and Week 12).
A QoL is carried out at D0 and end of the study for each patient included in the protocol.
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 (≥ 18 years old), having given free, informed and written consent
- •Patient affiliated to a social security scheme
- •Patient agreeing to wear the study compression system daily
- •Patient with an ankle circumference between 18 and 25 cm
- •Target wound: stage C6 / C6r mixed leg ulcer of the CEAP classification with a 0.6≤ ABPI≤0.8 and TABP≥ 50 mm Hg and arterial echo Doppler confirming the mixed nature of the leg ulcer
- •Target wound with an area between 2 and 20 cm2
- •Target wound with age of ≤18 months
排除标准
- •Patient with a systemic infection not controlled by appropriate antibiotic therapy
- •Patient having presented in the 3 months preceding his inclusion, a deep vein thrombosis
- •Severe arterial pathology, including an Ankle Blood Pressure Index (ABPI) less than 3 months old <0.6
- •Patient bedridden or spending less than an hour per day standing
- •Clinically infected target wound
- •Cancerized target wound
结局指标
主要结局
Complete closure of the Venous Leg Ulcer (VLU)
时间窗: 16-week treament period
Description: Complete closure of the leg ulcer is defined by 100% re-epithelialization of the mixed Leg Ulcer (MLU)
次要结局
- Time to complete closure of the Venous Leg Ulcer (VLU)(16-week treament period)
- Safety analysis(16-week treament period)