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Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia

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ClinicalTrials.gov Identifier: NCT01014377
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : May 21, 2010
Sponsor:
Information provided by:
VascuActive LTD

Brief Summary:
The purpose of this study is to assess the safety and the immediate effect of the VascuActive device on patients with peripheral vascular disease and limb ischemia.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Diseases Device: VascuActive Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Safety of the VascuActive™ Device and Its Preliminary Efficacy on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With Peripheral Vascular Disease and Limb Ischemia
Study Start Date : November 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

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Primary Outcome Measures :
  1. Pain-free and Maximal walking distance [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. Skin temperature [ Time Frame: 1 hour ]
  2. Skin blood flow [ Time Frame: 1 hour ]
  3. Transcutaneous partial pressure of O2 and CO2 [ Time Frame: 1 hour ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Leg Ischemia, Fontaine grade IIa and IIb, i.e.: pain free walking distance in the range of 50 - 100 meters.
  • Absent pulses in the two foot arteries (Anterior Tibial a., Posterior Tibial a.)
  • ABI < 0.7 by Doppler, in at least one of the two foot arteries

Exclusion Criteria:

  • Absent femoral pulses
  • Venous insufficiency by Duplex
  • Pregnancy
  • Infectious disease
  • Malignant disease
  • Severe cardiac disease, e.g., CHF grade 3 or higher
  • Acute MI within last 3 months
  • CABG within last 3 months
  • Other severe systemic disease

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): NCT01014377


Locations
Israel
Asaf Harofe Medical Center
Zrifin, Israel
Sponsors and Collaborators
VascuActive LTD

Responsible Party: Yuval Avni, VascuActive LTD
ClinicalTrials.gov Identifier: NCT01014377     History of Changes
Other Study ID Numbers: VAS-01
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: May 21, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases