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Completed

NCT Number: NCT05888740

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vascular & Interventional Specialists of Orange County

Orange, California, 92868, United States

About this study

The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in subjects with early stage PAD. Each subject will receive TUS treatment multiple sessions. All post- treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 65
  • Diagnosis of PAD.
  • Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator.

Exclusion criteria

  • Prior stenting in posterior tibial artery.
  • Re-vascularization procedure within 30 days prior to enrollment in the study.
  • Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
  • History or diagnosis of severe chronic venous insufficiency.
  • Acute limb ischemia within 30 days prior to treatment.
  • History or diagnosis of deep venous thrombosis below the knee in treatment leg.
  • 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.
  • Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period.

stenting in posterior tibial artery.

Treatment and study plan

VibratoSleeve Therapeutic Ultrasound Device

Device

The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf

Primary outcomes

  1. Mean Acute Flow Rate Difference During TUS Treatment Sessions

    Time frame: Baseline to end of treatment, an average of 1 month

    Percent change in perfusion measured by FlowMet calculated between baseline and after final treatment.

  2. Tissue Oxygen Saturation (StO2)

    Time frame: Through study completion, an average of 1 month

    Calculate changes in tissue oxygen saturation (StO2) measured non-invasively by Clarifi spatial frequency domain imaging system, compared from baseline to during and immediately post-treatment.

  3. Ankle Brachial Index (ABI)

    Time frame: Baseline to end of treatment, an average of 1 month

    ABI is ratio that compares blood pressure in the arm to blood pressure in the ankle. It is a measurement of the extent of peripheral arterial disease.

Secondary outcomes

  1. Incidence of Device and Procedure-related Adverse Events

    Time frame: Through study completion, an average of 1 month

    Number of adverse events related to the VibratoSleeve device or study procedure occurring throughout the duration of the study.

Sponsors and collaborators

Lead sponsor

Vibrato Medical, Inc.

Industry

Registry information

Official study title

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

Acronym: Waltz

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2023
Registry last updated
Jul 2, 2025

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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