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

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 Overview

• Status: Unknown
• Conditions: Quality of Life; Peripheral Artery Disease; Wound Healing
• Intervention / Treatment: Device: VADOplex system

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Claas Lüdemann, MD; Phone Number: +49 (0) 40 8191-2019

Study Locations

• Germany
  • Hamburg, Germany, 22559
    • Recruiting
    • Gefäßzentrum, Asklepios Westklinikum Hamburg
    • Contact: Claas Luedemann, MD; Phone Number: +49 (0) 40 8191-2019
    • Sub-Investigator: Claas Luedemann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VADOplex treatment; 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	Device: VADOplex system; intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system
No Intervention: conservative treatment; best medical treatment of the target lesion alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing	complete healing of the target lesion	at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
change of quality of life	change of quality of life compared to baseline. Quality of life measured with the EQ-5D tool (European quality of life in 5 dimensions)	at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to complete wound healing	time until complete wound healing of the target lesion is achieved	at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
Wound size	overall reduction of the size of the target lesion in patients with incomplete wound healing compared to baseline	at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
change of pain intensity	change of pain intensity compared to baseline. Pain intensity measured with a numeric rating scale (0 - 10) or if not applicable with a visual analogue scale	at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
change of ankle-brachial index	change of ankle-brachial index compared to basleline	at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
incidence of deep vein thrombosis		24 weeks after discharge or whenever a thrombosis is suspected

Collaborators and Investigators

• Sponsor: Asklepios Kliniken Hamburg GmbH
• Collaborators: OPED GmbH
• Investigators: Principal Investigator: Holger Lawall, MD, head of department

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): November 1, 2014

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Estimate): January 13, 2014
• Last Update Submitted That Met QC Criteria: January 10, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: critical limb ischemia; peripheral artery disease; VADOplex; intermittent foot compression
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: VADOplex-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No