Prospektive, Randomisierte Und Kontrollierte Studie Zum Einfluss Des VADOplex-Systems Auf Die Lebensqualität im Rahmen Der Behandlung Der Chronisch-kritischen Extremitätenischämie im Stadium IV Nach Fontaine
试验速览
- 阶段
- 2 期
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- wound healing
研究概览
简要总结
In patients with critical limb ischemia (CLI) and foot ulcers wound healing is an important goal which can normally only be achieved after sufficient treatment of the underlying ischemia (revascularization either by an operation, e. g. bypass, or a catheter intervention). After successful revascularization everything should be done to improve wound healing because this regularly takes weeks up to several months. One possibility to speed up healing could be treatment with the VADOplex device which delivers an automatic intermittent painless compression of the sole of the foot thereby increasing perfusion of the leg. This system can be easily operated by patients themselves and at home.
Our goal is to prove that the VADOPlex system accelerates healing up and improves quality of life.
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
- •signed informend consent
- •peripheral artery disease Fontaine IV (equals Ruterford 5 and 6) with or without neuropathy
- •foot lesion stage 1 - 4 analogous to 4 Wagner classification of the diabetic foot
- •secondary wound healing if previous surgical wound treatment
- •previous interventional and/or surgical revascularisation
- •age above 18
- •hosptalized to the beginning of the study
排除标准
- •primary wound healing if previous surgical wound treatment
- •uncontrolled local or systemic infection
- •renal failure on dialysis
- •inability or insufficient help to operate the VADOplex system
- •wound dressings that lead to insufficient compression by the VADOplex system (e.g. total contact cast for offloading)
- •wounds of other than ischemic or neuro-ischemic origin
结局指标
主要结局
wound healing
时间窗: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
complete healing of the target lesion
change of quality of life
时间窗: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
change of quality of life compared to baseline. Quality of life measured with the EQ-5D tool (European quality of life in 5 dimensions)
次要结局
- time to complete wound healing(at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge)
- Wound size(at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge)
- change of pain intensity(at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge)
- change of ankle-brachial index(at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge)
- incidence of deep vein thrombosis(24 weeks after discharge or whenever a thrombosis is suspected)
研究者
Claas Luedemann
Claas Luedemann, MD
Asklepios Kliniken Hamburg GmbH