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

This study has been completed.
Sponsor:
Information provided by:
VascuActive LTD
ClinicalTrials.gov Identifier:
NCT01014377
First received: November 11, 2009
Last updated: May 20, 2010
Last verified: May 2010
History of Changes
  Purpose

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 Intervention
Peripheral Vascular Diseases
 Device: VascuActive

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VascuActive LTD:

Primary Outcome Measures:
  • Pain-free and Maximal walking distance [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Skin temperature [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Skin blood flow [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Transcutaneous partial pressure of O2 and CO2 [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014377

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

No publications provided

Responsible Party: Yuval Avni, VascuActive LTD
ClinicalTrials.gov Identifier: NCT01014377     History of Changes
Other Study ID Numbers: VAS-01
Study First Received: November 11, 2009
Last Updated: May 20, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on May 23, 2013