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VADOplex Critical Limb Ischemia Study

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ClinicalTrials.gov Identifier: NCT02034539
Recruitment Status : Unknown
Verified January 2014 by Claas Luedemann, Asklepios Kliniken Hamburg GmbH.
Recruitment status was:  Recruiting
First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Collaborator:
OPED GmbH
Information provided by (Responsible Party):
Claas Luedemann, Asklepios Kliniken Hamburg GmbH

Tracking Information
First Submitted Date  ICMJE January 10, 2014
First Posted Date  ICMJE January 13, 2014
Last Update Posted Date January 13, 2014
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VADOplex Critical Limb Ischemia Study
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Artery Disease
  • Quality of Life
  • Wound Healing
Intervention  ICMJE Device: VADOplex system
intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system
Study Arms  ICMJE
  • 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
    Intervention: Device: VADOplex system
  • No Intervention: conservative treatment
    best medical treatment of the target lesion alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 10, 2014)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034539
Other Study ID Numbers  ICMJE VADOplex-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Claas Luedemann, Asklepios Kliniken Hamburg GmbH
Study Sponsor  ICMJE Asklepios Kliniken Hamburg GmbH
Collaborators  ICMJE OPED GmbH
Investigators  ICMJE
Principal Investigator: Holger Lawall, MD head of department
PRS Account Asklepios Kliniken Hamburg GmbH
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP