Effect of VascuActive Device on Foot Perfusion, Hemodynam... | NCT01014377

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

NCT01014377

Sponsor

VascuActive LTD

Status

Completed

Last Update Posted

May 21, 2010Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Peripheral Vascular Diseases

Interventions

VascuActive

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Nov 11, 2009

First Submission Date that Met QC Criteria

Nov 16, 2009

First Posted Date

Nov 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2010

Last Update Posted Date

May 21, 2010Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Name	Type	Description	Arm Group Labels	Other Names
VascuActive	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain-free and Maximal walking distance		1 hour

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asaf Harofe Medical Center		Zrifin			Israel

Condition Browse Module

MeSH Terms

ID	Term
D016491	Peripheral Vascular Diseases

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided