VADOplex Critical Limb Ischemia Study

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.

Full Title of 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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Interventions

  • Device: VADOplex system
    • intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system

Arms, Groups and Cohorts

  • 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
  • No Intervention: conservative treatment
    • best medical treatment of the target lesion alone

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • time to complete wound healing
    • Time Frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
    • time until complete wound healing of the target lesion is achieved
  • Wound size
    • Time Frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
    • overall reduction of the size of the target lesion in patients with incomplete wound healing compared to baseline
  • change of pain intensity
    • Time Frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
    • 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
  • change of ankle-brachial index
    • Time Frame: at discharge, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 24 weeks after discharge
    • change of ankle-brachial index compared to basleline
  • incidence of deep vein thrombosis
    • Time Frame: 24 weeks after discharge or whenever a thrombosis is suspected

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asklepios Kliniken Hamburg GmbH
  • Collaborator
    • OPED GmbH
  • Provider of Information About this Clinical Study
    • Principal Investigator: Claas Luedemann, Claas Luedemann, MD – Asklepios Kliniken Hamburg GmbH
  • Overall Official(s)
    • Holger Lawall, MD, Principal Investigator, head of department
  • Overall Contact(s)
    • Claas Lüdemann, MD, +49 (0) 40 8191-2019

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.