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

November 11, 2009
May 20, 2010
November 2009
April 2010   (final data collection date for primary outcome measure)
Pain-free and Maximal walking distance [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01014377 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia
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

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Vascular Diseases
Device: VascuActive
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01014377
VAS-01
Not Provided
Yuval Avni, VascuActive LTD
VascuActive LTD
Not Provided
Not Provided
VascuActive LTD
May 2010

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