VADOplex Critical Limb Ischemia Study

Phase 3UnknownNCT02034539

Asklepios Kliniken Hamburg GmbH38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Artery Disease Quality of Life Wound Healing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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