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OpenTrials
Completed

NCT Number: NCT01014377

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

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.

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Key information

Conditions

Peripheral Vascular Diseases Cardiovascular Diseases Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asaf Harofe Medical Center

Zrifin, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VascuActive

Device

Primary outcomes

  1. Pain-free and Maximal walking distance

    Time frame: 1 hour

Secondary outcomes

  1. Skin temperature

    Time frame: 1 hour

  2. Skin blood flow

    Time frame: 1 hour

  3. Transcutaneous partial pressure of O2 and CO2

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

VascuActive LTD

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 17, 2009
Registry last updated
May 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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