VADOplex Critical Limb Ischemia Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Peripheral Artery Disease, Quality of Life, Wound Healing

Intervention / Treatment
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* Device: VADOplex system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VADOplex treatment<br>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 | Device: VADOplex system<br>* intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system<br>|
| No Intervention: conservative treatment<br>best medical treatment of the target lesion alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing | complete healing of the target lesion | at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge | 
| change of quality of life | change of quality of life compared to baseline. Quality of life measured with the EQ-5D tool (European quality of life in 5 dimensions) | at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to complete wound healing | time until complete wound healing of the target lesion is achieved | at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge | 
| Wound size | overall reduction of the size of the target lesion in patients with incomplete wound healing compared to baseline | at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge | 
| change of pain intensity | 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 | at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge | 
| change of ankle-brachial index | change of ankle-brachial index compared to basleline | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical limb ischemia, VADOplex, intermittent foot compression, peripheral artery disease