Peripheral Arterial DiseaseWaltzNCT05888740

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

A study testing VibratoSleeve Therapeutic Ultrasound Device in people with Peripheral Arterial Disease, run by Vibrato Medical, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: VibratoSleeve Therapeutic Ultrasound Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 22 Feb 2023to 10 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Vascular & Interventional Specialists of Orange County
Orange, California, 92868

Other trials in United States

About this study

Official 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

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.

Read the detailed description

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.

Conditions: Peripheral Arterial Disease
Being tested: VibratoSleeve Therapeutic Ultrasound Device
Keywords: Therapeutic Ultrasound (TUS), Peripheral Artery Disease (PAD), Critical Limb Ischemia (CLI)
Medical subject headings: Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05888740
Study group	Role	What they receive
TUS Therapy	Experimental	These subjects will undergo treatments with the Vibrato Sleeve TUS device. Receives: Device: VibratoSleeve Therapeutic Ultrasound Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Acute Flow Rate Difference During TUS Treatment Sessions
Percent change in perfusion measured by FlowMet calculated between baseline and after final treatment.
Measured: Baseline to end of treatment, an average of 1 month
Tissue Oxygen Saturation (StO2)
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.
Measured: Through study completion, an average of 1 month
Ankle Brachial Index (ABI)
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.
Measured: Baseline to end of treatment, an average of 1 month

Secondary outcomes (1)

Incidence of Device and Procedure-related Adverse Events
Number of adverse events related to the VibratoSleeve device or study procedure occurring throughout the duration of the study.
Measured: Through study completion, an average of 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 202310 Oct 2024

First posted5 Jun 2023
Study start22 Feb 2023
Primary completion10 Oct 2024
Study completion10 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective, single arm, open-label, feasibility acute phase study
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05888740
Sponsor's protocol ID: 022-01
Acronym: Waltz
Status last verified: Jun 2025
First submitted: 24 May 2023
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Nazer B, Ghahghaie F, Kashima R, Khokhlova T, Perez C, Crum L, Matula T, Hata A. Therapeutic Ultrasound Promotes Reperfusion and Angiogenesis in a Rat Model of Peripheral Arterial Disease. Circ J. 2015;79(9):2043-9. doi: 10.1253/circj.CJ-15-0366. Epub 2015 Jun 9.
PubMed 26062950

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)

All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05888740
Acronym / sponsor ID: Waltz / 022-01
Conditions: Peripheral Arterial Disease
Keywords: Therapeutic Ultrasound (TUS), Peripheral Artery Disease (PAD), Critical Limb Ischemia (CLI)
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Vibrato Medical, Inc.Industry (pharma, biotech, devices)
Study start: 22 Feb 2023 (actual)
Primary completion: 10 Oct 2024 (actual)
Study completion: 10 Oct 2024 (actual)
First posted: 5 Jun 2023 (actual)
Results: Posted 2 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, single arm, open-label, feasibility acute phase study

Arm	Type	Receives
TUS Therapy	Experimental	Device: VibratoSleeve Therapeutic Ultrasound DeviceThese subjects will undergo treatments with the Vibrato Sleeve TUS device.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VibratoSleeve Therapeutic Ultrasound DeviceThe VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf	Device	TUS Therapy

Primary outcome

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.
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.
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.

1 secondary outcome

Incidence of Device and Procedure-related Adverse Events
Time frame: Through study completion, an average of 1 month

Results and safety

Results posted to the registry on 2 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TUS Therapy	12	12

Primary outcome: Mean Acute Flow Rate Difference During TUS Treatment Sessions

Time frame: Baseline to end of treatment, an average of 1 month. Mean (Standard Deviation). Unit: Percent change (%)

Measure	TUS Therapy n = 12
Value	27.3 (50.8)

Primary outcome: Tissue Oxygen Saturation (StO2)

Time frame: Through study completion, an average of 1 month. Mean (Standard Deviation). Unit: StO2%

Measure	TUS Therapy n = 12
Value	1.0 (8.4)

Primary outcome: Ankle Brachial Index (ABI)

Time frame: Baseline to end of treatment, an average of 1 month. Mean (Standard Deviation). Unit: Index (Ratio)

Measure	TUS Therapy n = 12
Value	0.0 (0.12)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Safety surveillance and reporting starts when subject receives therapy with the VibratoSleeve until the end of the final treatment visit. All treatment visits were completed within an average of 1 month per patient.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TUS Therapy	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26062950Nazer B, Ghahghaie F, Kashima R, Khokhlova T, Perez C, Crum L, Matula T, Hata A. Therapeutic Ultrasound Promotes Reperfusion and Angiogenesis in a Rat Model of Peripheral Arterial Disease. Circ J. 2015;79(9):2043-9. doi: 10.1253/circj.CJ-15-0366. Epub 2015 Jun 9.
Individual participant dataSharing planned: No

Related trials for Peripheral Arterial Disease

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VibratoSleeve Therapeutic Ultrasound Device in people with Peripheral Arterial Disease, run by Vibrato Medical, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Acute Flow Rate Difference During TUS Treatment Sessions (time frame: Baseline to end of treatment, an average of 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05888740, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.