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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
Awards & highlights

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 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.

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.

Find a Location

Who is running the clinical trial?

Vascular and Interventional Specialists of Orange County, Inc. (VISOC)UNKNOWN
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
12 Patients Enrolled for Peripheral Arterial Disease
Vibrato Medical, Inc.Lead Sponsor
3 Previous Clinical Trials
36 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
36 Patients Enrolled for Peripheral Arterial Disease

Media Library

VibratoSleeve (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05100745 — N/A
Peripheral Arterial Disease Research Study Groups: Activated Therapy, Sham Therapy
Peripheral Arterial Disease Clinical Trial 2023: VibratoSleeve Highlights & Side Effects. Trial Name: NCT05100745 — N/A
VibratoSleeve (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05100745 — N/A
~1 spots leftby Dec 2024