Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia
Not Applicable
Completed
- Conditions
- Peripheral Vascular Diseases
- Registration Number
- NCT01014377
- Lead Sponsor
- VascuActive LTD
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Pain-free and Maximal walking distance 1 hour
- Secondary Outcome Measures
Name Time Method Transcutaneous partial pressure of O2 and CO2 1 hour Skin temperature 1 hour Skin blood flow 1 hour
Trial Locations
- Locations (1)
Asaf Harofe Medical Center
🇮🇱Zrifin, Israel