What side effects are associated with this type of intervention?

Common treatments for Peripheral Arterial Disease (PAD) include supervised exercise therapy, pharmacologic therapy (e.g., cilostazol, statins), and revascularization procedures (e.g., angioplasty, stenting). Supervised exercise therapy is generally safe but may cause muscle soreness. Pharmacologic treatments can have side effects such as headaches, gastrointestinal issues, and increased bleeding risk. Revascularization procedures carry risks of infection, bleeding, and restenosis. For treatments similar to the Vibrato Sleeve TUS, which uses therapeutic ultrasound to improve blood flow, potential side effects may include localized pain, skin irritation, and transient changes in blood flow dynamics.

What prior FDA approvals exist?

The FDA has approved several treatments for Peripheral Arterial Disease (PAD), primarily focusing on pharmacologic therapies and revascularization techniques. Pharmacologic treatments include antiplatelet agents like aspirin and clopidogrel, and the phosphodiesterase inhibitor cilostazol, which helps improve walking distance in patients with claudication. Revascularization techniques such as percutaneous transluminal angioplasty (PTA) and the use of stents, including drug-eluting stents, have also been approved. While specific FDA approvals for therapeutic ultrasound systems like the Vibrato Sleeve TUS are not detailed, the focus remains on improving blood flow and reducing symptoms of claudication in PAD patients.

What other types of research exist?

Promising alternatives to Vibrato Sleeve TUS for PAD patients include: 1) Supervised Exercise Programs (SEP), which have shown long-term benefits in improving walking distances and functional status. 2) High-intensity statin therapy, which has been associated with reduced mortality and major adverse limb events. 3) PCSK9 inhibitors like evolocumab and alirocumab, which have demonstrated significant reductions in cardiovascular and limb events. 4) Endovascular revascularization techniques, such as percutaneous transluminal angioplasty (PTA), which can improve blood flow and reduce ischemic symptoms.

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Therapeutic Device for Peripheral Arterial Disease (Concerto Trial)

N/A

Waitlist Available

Research Sponsored by Vibrato Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of infrapopliteal PAD

Age ≥22

Must not have

Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf)

History or diagnosis of deep venous thrombosis below the knee in treatment leg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Summary

This trial is testing a wearable device called the Vibrato Sleeve TUS, which uses sound waves to help improve blood flow in people with peripheral artery disease (PAD). Participants will use either the actual device or a non-functional version to see if it helps. The goal is to see if the device is safe and effective for improving leg circulation.

Who is the study for?

This trial is for adults over 22 with severe peripheral artery disease (PAD) in the legs, specifically those classified as Rutherford class 4 or 5. Participants must have a Toe Brachial Index of 0.6 or less, or toe blood pressure below 50 mmHg. It's not for those who've had recent leg stents, re-vascularization procedures within the last month, skin issues on their calf, severe vein problems in their legs, recent acute limb ischemia, untreated deep vein thrombosis below the knee in the affected leg, uncontrolled diabetes with HbA1c over 10%, ongoing oxygen treatment under pressure or if they're part of another study.

What is being tested?

The trial is testing a device called Vibrato Sleeve TUS to see if it's safe and effective for improving blood flow in people with PAD. The goal is to find out whether this therapeutic device can help patients by changing how much blood gets through their arteries.

What are the potential side effects?

Since this trial involves a therapeutic device rather than medication, side effects may include local reactions at the site where the device is used such as discomfort or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a blockage in the arteries below my knees.

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I am 22 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a severe long-term vein or mixed blood vessel condition.

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I am currently receiving hyperbaric oxygen therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in foot perfusion

Secondary study objectives

Adverse Events

Subject Questionnaire

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Activated TherapyExperimental Treatment1 Intervention

Therapy: these subjects will undergo 30 treatments with an activated Vibratosleeve TUS device.

Group II: Sham TherapyPlacebo Group1 Intervention

An inactive (sham) device will be used in these subjects for the first 30 treatments followed by a 30-treatment regimen with an activated VibratoSleeve TUS device after crossover.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Peripheral Arterial Disease (PAD) include supervised exercise therapy, pharmacologic agents like statins and antiplatelet drugs, and revascularization procedures. Supervised exercise therapy improves walking ability and functional status by promoting vascular health and enhancing muscle efficiency. Statins reduce cholesterol levels, slowing atherosclerosis progression, while antiplatelet agents prevent blood clots, reducing the risk of cardiovascular events. Revascularization procedures, such as angioplasty, restore blood flow to affected limbs. The Vibrato Sleeve TUS, a therapeutic ultrasound system, aims to enhance blood flow through mechanical stimulation, potentially offering a non-invasive alternative to improve perfusion in PAD patients. These treatments are crucial as they address the underlying vascular issues, improve symptoms, and reduce the risk of severe complications like limb ischemia and cardiovascular events.

Treatment for intermittent claudication and the effects on walking distance and quality of life.