VADOplex Critical Limb Ischemia Study

Asklepios Kliniken Hamburg GmbH

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Peripheral Artery Disease; Quality of Life; Wound Healing

Treatments: Device: VADOplex system

Study type: Interventional

Funder types: Other

Identifiers

NCT02034539

VADOplex-1

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

VADOplex treatment

Experimental group

Description:

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

Treatment:

Device: VADOplex system

conservative treatment

No Intervention group

Description:

best medical treatment of the target lesion alone