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

Peripheral Vascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014377
• Other study ID #: VAS-01
• Status: Completed
• Phase: N/A
• First received: November 11, 2009
• Last updated: May 20, 2010
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: VascuActive LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• VascuActive

Locations

Country	Name	City	State
Israel	Asaf Harofe Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
VascuActive LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain-free and Maximal walking distance		1 hour	Yes
Secondary	Skin temperature		1 hour	No
Secondary	Skin blood flow		1 hour	No
Secondary	Transcutaneous partial pressure of O2 and CO2		1 hour	No