Peripheral Artery Disease, Quality of Life, Wound Healing
Conditions
Keywords
peripheral artery disease, critical limb ischemia, VADOplex, intermittent foot compression
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.
Interventions
DEVICEVADOplex system
intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system
Sponsors
OPED GmbH
Asklepios Kliniken Hamburg GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| incidence of deep vein thrombosis | 24 weeks after discharge or whenever a thrombosis is suspected | — |
| 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 |
| 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 |
Countries
Germany
Contacts
Primary ContactClaas Lüdemann, MD
Outcome results
None listed