Therapeutic Ultrasound for Peripheral Arterial Disease
(Waltz Trial)

Recruiting in Palo Alto (17 mi)

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Vibrato Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people aged 65 or older who have Peripheral Arterial Disease (PAD) and experience leg pain when walking, classified as Rutherford class 1,2, or 3. It's not suitable for those with severe venous issues, recent limb ischemia, stenting in the tibial artery, recent re-vascularization procedures, deep vein thrombosis below the knee in the treatment leg, skin problems in treatment areas or those participating in another study.

Inclusion Criteria

I am 65 years old or older.

I have been diagnosed with peripheral artery disease (PAD).

I experience leg pain from walking but can walk without assistance.

Exclusion Criteria

I have had a sudden loss of blood flow to a limb within the last 30 days.

I have no ulcers or skin issues on the back of my lower leg.

I have had a deep vein clot in my leg below the knee.

+5 more

Participant Groups

The study is testing a device called VibratoSleeve Therapeutic Ultrasound to see if it can improve blood flow and reduce symptoms in patients with PAD. Participants will use this non-invasive device to determine its effectiveness and feasibility as a treatment option.

1Treatment groups

Experimental Treatment

Group I: TUS TherapyExperimental Treatment1 Intervention

These subjects will undergo treatments with the Vibrato Sleeve TUS device.