Back to resultsEffect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia
Primary Purpose
Peripheral Vascular Diseases
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
VascuActive
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Diseases
Eligibility Criteria
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
Sites / Locations
- Asaf Harofe Medical Center
Outcomes
Primary Outcome Measures
Pain-free and Maximal walking distance
Secondary Outcome Measures
Skin temperature
Skin blood flow
Transcutaneous partial pressure of O2 and CO2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01014377
Brief Title
Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
VascuActive LTD
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
VascuActive
Primary Outcome Measure Information:
Title
Pain-free and Maximal walking distance
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Skin temperature
Time Frame
1 hour
Title
Skin blood flow
Time Frame
1 hour
Title
Transcutaneous partial pressure of O2 and CO2
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asaf Harofe Medical Center
City
Zrifin
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia
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