VADOplex Critical Limb Ischemia Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02034539
Study type	Interventional
Source	Asklepios Kliniken Hamburg GmbH
Contact	Claas Lüdemann, MD
Phone	+49 (0) 40 8191-2019
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	October 2013
Completion date	November 2014

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