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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01014377

Enrollment

Registered

2009-11-17

Start date

2009-11-30

Completion date

2010-04-30

Last updated

2010-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vascular Diseases

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.

Interventions

DEVICEVascuActive

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pain-free and Maximal walking distance	1 hour

Secondary

Measure	Time frame
Skin temperature	1 hour
Skin blood flow	1 hour
Transcutaneous partial pressure of O2 and CO2	1 hour

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026