Clinical trial NCT02034539: VADOplex Critical Limb Ischemia Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Peripheral Artery Disease
Quality of Life
Wound Healing
Keywords: peripheral artery disease
critical limb ischemia
VADOplex
intermittent foot compression
Lead sponsor: Asklepios Kliniken Hamburg GmbH
Sponsor class: OTHER
Collaborators: name: OPED GmbH
First posted: 2014-01-13
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: wound healing
timeFrame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
measure: change of quality of life
timeFrame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
Secondary outcomes:
measure: time to complete wound healing
timeFrame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
measure: Wound size
timeFrame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
measure: change of pain intensity
timeFrame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
measure: change of ankle-brachial index
timeFrame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
measure: incidence of deep vein thrombosis
timeFrame: 24 weeks after discharge or whenever a thrombosis is suspected
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Gefäßzentrum, Asklepios Westklinikum Hamburg
Study officials:
affiliation: head of department
name: Holger Lawall, MD
role: PRINCIPAL_INVESTIGATOR
References: