NCT02034539

VADOplex Critical Limb Ischemia Study

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Asklepios Kliniken Hamburg GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Artery Disease
• Quality of Life
• Wound Healing

Interventions

Type	Name	Description
DEVICE	VADOplex system	intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2014-01-13
• Last updated: 2014-01-13

Locations

1 site across 1 country: Germany