Peripheral Arterial DiseaseConcertoNCT05100745
A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD
A study testing Therapeutic Device in people with Peripheral Arterial Disease, run by Vibrato Medical, Inc. at 1 site in United States.
Trial summary
The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Therapeutic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥22.
- Diagnosis of infrapopliteal PAD.
- Rutherford class 4 or 5 as determined by the investigator.
- Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg.
Who cannot join
- Prior stenting in posterior tibial, anterior tibial or peroneal artery.
- Re-vascularization procedure within 25 days prior to enrollment in the study. (Note: Patients who had re-vascularization procedure earlier than 25 days prior to enrollment are eligible for enrollment if they meet other criteria).
- Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
- History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
- 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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- Uncontrolled diabetes defined as HbA1c greater than 10%.
- Ongoing hyperbaric oxygen treatment (HBOT)
- Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study or lead to difficulties for patient compliance with study requirements, or could confound study data.
- 9. Patient's enrollment in another investigational study that has not completed the required primary endpoint follow-up period (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vascular & Interventional Specialists of Orange County
Orange, California, 92868
About this study
Official title: A Non-significant Risk Clinical Study to Assess Changes in Perfusion Resulting From Application of the VibratoSleeve, a Therapeutic Ultrasound (TUS) Phased Array, for Patients With Peripheral Arterial Disease (PAD)
The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD).
Read the detailed description
Subjects will be randomized to a test or control group and will receive an active or sham Vibrato Sleeve respectively.
Those randomized to the control arm will undergo therapy sessions with a sham Vibrato Sleeve device and two months of follow-up. Upon completion of the 2-month follow-up visit, subjects will be informed of their randomization assignment. Subjects in the sham arm will be allowed to crossover to a treatment regimen that uses an active Vibrato Sleeve device and will follow the same visit schedule as the active test group.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Therapeutic 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.
Therapeutic DeviceDevice
Also called VibratoSleeve TUS Device
This device delivers ultrasound energy to the targeted area of the lower limb.
| Study group | Role | What they receive |
|---|---|---|
| Activated Therapy | Experimental | Therapy: these subjects will undergo 30 treatments with an activated Vibratosleeve TUS device. Receives: Device: Therapeutic Device |
| Sham Therapy | Sham comparator | 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. Receives: Device: Therapeutic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in foot perfusion
Mean difference between pre-treatment (baseline) and/or last sham treatment with post-treatment measurements, including the 2-month follow-up.
Measured: 4 months
Secondary outcomes (2)
Adverse Events
Analysis of all reported device-related adverse events throughout each subject's participation.
Measured: up to and including the 2-month follow-up visit for test and control subjects.
Subject Questionnaire
Questions will be based on each treatment session and what each subject felt and observed.
Measured: up to and including the 2-month follow-up visit for test and control subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start13 Mar 2023
- Primary completion31 May 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, double-blinded, randomized controlled trial to evaluate the feasibility of TUS in the treatment of PAD.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibrato Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100745
- Sponsor's protocol ID
- 21-001
- Acronym
- Concerto
- Status last verified
- Jun 2025
- First submitted
- 21 Oct 2021
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data summaries, group outcomes, and study conclusions will be shared with other researchers. Individual participant data will not be shared.
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-significant Risk Clinical Study to Assess Changes in Perfusion Resulting From Application of the VibratoSleeve, a Therapeutic Ultrasound (TUS) Phased Array, for Patients With Peripheral Arterial Disease (PAD)
- ClinicalTrials.gov ID
- NCT05100745
- Acronym / sponsor ID
- Concerto / 21-001
- Conditions
- Peripheral Arterial Disease
- Keywords
- Therapeutic Ultrasound (TUS), Peripheral Artery Disease (PAD), Critical Limb Ischemia (CLI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Vibrato Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD).
Detailed description
Subjects will be randomized to a test or control group and will receive an active or sham Vibrato Sleeve respectively.
Those randomized to the control arm will undergo therapy sessions with a sham Vibrato Sleeve device and two months of follow-up. Upon completion of the 2-month follow-up visit, subjects will be informed of their randomization assignment. Subjects in the sham arm will be allowed to crossover to a treatment regimen that uses an active Vibrato Sleeve device and will follow the same visit schedule as the active test group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, double-blinded, randomized controlled trial to evaluate the feasibility of TUS in the treatment of PAD.
| Arm | Type | Receives |
|---|---|---|
| Activated Therapy | Experimental | Device: Therapeutic DeviceTherapy: these subjects will undergo 30 treatments with an activated Vibratosleeve TUS device. |
| Sham Therapy | Sham comparator | Device: Therapeutic DeviceAn 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥22.
- Diagnosis of infrapopliteal PAD.
- Rutherford class 4 or 5 as determined by the investigator.
- Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg.
Key exclusion criteria (10 listed)
- Prior stenting in posterior tibial, anterior tibial or peroneal artery.
- Re-vascularization procedure within 25 days prior to enrollment in the study. (Note: Patients who had re-vascularization procedure earlier than 25 days prior to enrollment are eligible for enrollment if they meet other criteria).
- Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
- History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
- 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 |
|---|---|---|
| Therapeutic DeviceAlso: VibratoSleeve TUS DeviceThis device delivers ultrasound energy to the targeted area of the lower limb. | Device | Activated Therapy, Sham Therapy |
Primary outcome
Changes in foot perfusion
Time frame: 4 months
Mean difference between pre-treatment (baseline) and/or last sham treatment with post-treatment measurements, including the 2-month follow-up.
2 secondary outcomes
Adverse Events
Time frame: up to and including the 2-month follow-up visit for test and control subjects.
Subject Questionnaire
Time frame: up to and including the 2-month follow-up visit for test and control subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- 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. Data summaries, group outcomes, and study conclusions will be shared with other researchers. Individual participant data will not be shared.
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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 Therapeutic 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 4 inclusion and 10 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 17 Jun 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in foot perfusion (time frame: 4 months). 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 NCT05100745, 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 17 Jun 2025.