NCT01014377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 21, 2010

Status Verified

May 1, 2010

Enrollment Period

5 months

First QC Date

November 11, 2009

Last Update Submit

May 20, 2010

Conditions

Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Pain-free and Maximal walking distance

    1 hour

Secondary Outcomes (3)

  • Skin temperature

    1 hour

  • Skin blood flow

    1 hour

  • Transcutaneous partial pressure of O2 and CO2

    1 hour

Interventions

VascuActiveDEVICE

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf Harofe Medical Center

Zrifin, Israel

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 11, 2009

First Posted

November 17, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 21, 2010

Record last verified: 2010-05

Locations

IL(1)