Comparative and Prospective Evaluation of Direct Cost of Venous Leg Ulcers Management With Two Compression Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Direct cost of leg ulcer management
研究概览
简要总结
The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.
详细描述
The purpose of this study is to evaluate direct costs of Venous Leg Ulcers management when two different compression systems are used. Micro-costing during the study will bring direct costs which include nurse and physician time, dressings and bandages.
Perspective of costs will be Public Health Insurance. Time horizon will be 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
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consent to participate
- •ambulatory management
- •1 to 3 leg ulcers
- •leg ulcers below the knee and above ankle
- •no contra-indication to wear compression bandage
- •not currently treated by one of the investigational devices
排除标准
- •cognitive impairment
- •opposition to wear compression bandage
- •bedridden
- •pregnancy
研究组 & 干预措施
Compression1
Multilayer compression bandage (Profore)
干预措施: Profore (Device)
Compression2
Coban2 compression system
干预措施: Coban2 (Device)
结局指标
主要结局
Direct cost of leg ulcer management
时间窗: 16 weeks
Direct cost includes cost of bandages, dressings, nurse/doctor visits. Cost will be computed upon consumptions reported by healthcare professionals.
次要结局
- Patient's compression bandage acceptance score(16 weeks)
- Number of patients with fully healed ulcer(16 weeks)
- EuroQoL 5D-5L change between baseline and last visit(16 weeks)
- Average time to full healing(16 weeks)
- Prevalence of adverse events related to compression(16 weeks)