Therapeutic Ultrasound for Peripheral Arterial Disease

(Waltz Trial)

Overseen By Juliana Elstad

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Vibrato Medical, Inc.

Disqualifiers: Severe venous insufficiency, ulcers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

12 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TUS treatment with the VibratoSleeve device to assess acute vasodilatory and perfusion effects

4 weeks

Multiple sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VibratoSleeve Therapeutic Ultrasound Device

Trial Overview 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.

Participant Groups

Group I: TUS Therapy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Vibrato Medical, Inc.

Lead Sponsor

Trials

4

Recruited

70+