VADOplex Critical Limb Ischemia Study
- Conditions
- Peripheral Artery DiseaseQuality of LifeWound Healing
- Interventions
- Device: VADOplex system
- Registration Number
- NCT02034539
- Lead Sponsor
- Asklepios Kliniken Hamburg GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 38
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VADOplex treatment VADOplex system best medical treatment in combination with intermittent pneumatic foot compression by the VADOplex system for 4 - 6 hours/day until total wound closure of the target lesion is achieved with a maximum treatment of 24 weeks
- Primary Outcome Measures
Name Time Method wound healing 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 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)
- Secondary Outcome Measures
Name Time Method time to complete wound healing at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge time until complete wound healing of the target lesion is achieved
Wound size at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge overall reduction of the size of the target lesion in patients with incomplete wound healing compared to baseline
change of pain intensity at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge change of pain intensity compared to baseline. Pain intensity measured with a numeric rating scale (0 - 10) or if not applicable with a visual analogue scale
change of ankle-brachial index at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge change of ankle-brachial index compared to basleline
incidence of deep vein thrombosis 24 weeks after discharge or whenever a thrombosis is suspected
Trial Locations
- Locations (1)
Gefäßzentrum, Asklepios Westklinikum Hamburg
🇩🇪Hamburg, Germany