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VADOplex Critical Limb Ischemia Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Quality of Life Wound Healing Device: VADOplex system Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : October 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. incidence of deep vein thrombosis [ Time Frame: 24 weeks after discharge or whenever a thrombosis is suspected ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034539


Contacts
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Contact: Claas Lüdemann, MD +49 (0) 40 8191-2019

Locations
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Germany
Gefäßzentrum, Asklepios Westklinikum Hamburg Recruiting
Hamburg, Germany, 22559
Contact: Claas Luedemann, MD    +49 (0) 40 8191-2019      
Sub-Investigator: Claas Luedemann, MD         
Sponsors and Collaborators
Asklepios Kliniken Hamburg GmbH
OPED GmbH
Investigators
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Principal Investigator: Holger Lawall, MD head of department

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Responsible Party: Claas Luedemann, Claas Luedemann, MD, Asklepios Kliniken Hamburg GmbH
ClinicalTrials.gov Identifier: NCT02034539    
Other Study ID Numbers: VADOplex-1
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014
Keywords provided by Claas Luedemann, Asklepios Kliniken Hamburg GmbH:
peripheral artery disease
critical limb ischemia
VADOplex
intermittent foot compression
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases