Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)

Description

This study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (PAD) patients 65 years of age and over.

Conditions

Peripheral Arterial Disease

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Study Overview

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Study Details

Study overview

This study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (PAD) patients 65 years of age and over.

A Prospective, Non-significant Risk, Feasibility Study to Evaluate Serial Applications of VibratoSleeve Therapy to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD) Subjects 65 Years of Age and Older

Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)

Condition
Peripheral Arterial Disease
Intervention / Treatment

-

Contacts and Locations

Orange

Vascular & Interventional Specialists of Orange County, Orange, California, United States, 92868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥ 65
  • 2. Diagnosis of PAD.
  • 3. Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator.
  • 1. Prior stenting in posterior tibial artery.
  • 2. Re-vascularization procedure within 30 days prior to enrollment in the study.
  • 3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
  • 4. History or diagnosis of severe chronic venous insufficiency.
  • 5. Acute limb ischemia within 30 days prior to treatment.
  • 6. History or diagnosis of deep venous thrombosis below the knee in treatment leg.
  • 7. Any conditions that, in the opinion of the investigator, may render the subject unable to complete the study or lead to difficulties for subject compliance with study requirements, or could confound study data.
  • 8. Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period.

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Vibrato Medical, Inc.,

Study Record Dates

2024-12-31