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

Tracking Information
First Received Date ^ICMJE	November 11, 2009
Last Updated Date	May 20, 2010
Start Date ^ICMJE	November 2009
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 16, 2009)	Pain-free and Maximal walking distance [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01014377 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 16, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Peripheral Vascular Diseases
Intervention ^ICMJE	Device: VascuActive
Study Arm (s)	Not Provided
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	Completed
Estimated Enrollment ^ICMJE	15
Completion Date	April 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01014377
Other Study ID Numbers ^ICMJE	VAS-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Yuval Avni, VascuActive LTD
Study Sponsor ^ICMJE	VascuActive LTD
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	VascuActive LTD
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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