Peripheral Arterial Disease (PAD)NCT05149664
A Non-significant Risk Clinical Study: Changes in Perfusion After Therapeutic Ultrasound in Patients With PAD
A study testing Therapeutic ultrasound (TUS) in people with Peripheral Arterial Disease (PAD), run by Vibrato Medical, Inc. at 1 site in United States.
Trial summary
All evaluable subjects will receive VibratoSleeve therapeutic ultrasound (TUS) treatments. The device will be programmed to deliver TUS at a pre-determined level. Three different acoustic intensity levels will be tested during the first three treatment visits (one at each visit day). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Peripheral Arterial Disease (PAD)
- What is being tested?
- Therapeutic ultrasound (TUS)
- 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
- 14 Jan 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3, 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 all other criteria are met).
- 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.
Show all 10Show fewer
- Uncontrolled diabetes defined as HbA1c greater than 10%.
- 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.
- 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).
- Eligibility for patients with bi-lateral PAD will be assessed based on the leg that has more advanced PAD. For bi-lateral PAD patients only one leg with the more advanced bi-lateral PAD will be treated.
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)
All evaluable subjects will receive VibratoSleeve therapeutic ultrasound (TUS) treatments. The device will be programmed to deliver TUS at a pre-determined level. Three different acoustic intensity levels will be tested during the first three treatment visits (one at each visit day). The most effective treatment that is comfortable to a subject will be prescribed for the remaining treatment sessions. Treatment time will be 90 minutes per session, one session per day. Thirty treatment sessions will be performed over a 45-day period.
Subjects will appear for on-site follow-up visits at 1-, 3-, and 6-months following subject's last (30th) treatment session.
Read the detailed description
Screening procedures:
Prospective participants will be recruited for participation and informed consent will be obtained after all information is presented and all questions are answered to the patient's satisfaction. Once informed consent is obtained, the study team will confirm the patient meets all inclusion criteria and no exclusion criteria.
The following is a list of all assessments and tests that are required during the screening visit.
- Medical history, demographics, and Rutherford Class, vital signs, \& circumference measurement of one calf.
- Ankle Brachial Index and Toe Brachial Index (ABI/TBI) will be measured at screening to determine eligibility and baseline values.
- Ultrasonography and Perfusion Imaging of the Foot will be undertaken prior to, during and after application of the VibratoSleeve TUS. All patients will undergo arterial duplex ultrasound at the level of the calf, ankle and/or foot to document the baseline vessel diameter, vessel velocity and volume flow. Perfusion imaging of the foot will be completed, using non-invasive methods like Flowmet by Medtronic, Inc. and Clarifi system by Modulim.
Treatments:
The initial three VibratoSleeve therapy sessions in this study will be performed at a clinical research center (VISOC).
Only subjects who have met all the inclusion criteria and none of the exclusion criteria will receive therapy. The device will be fitted and operated by Vibrato team member(s) while accompanied by site study staff. Study-related imaging will be performed by licensed vascular ultrasound technicians.
After pre-treatment imaging, Vibrato staff will fit the device to the posterior calf and couple it to skin with ultrasound gel. Therapy will be initiated using a Vibrato generator, gradually increasing acoustic output over the first 5 minutes of therapy to a nominal goal peak negative pressure, while assessing patient comfort.
During the first three 90-minute therapy sessions, ABI, TBI, ultrasonography and perfusion imaging of foot will be performed pre-treatment, during the 90-minute treatment, and immediately after the end of treatment, using identical methods to those described for screening (see above). It should be noted that ultrasound administration can be immediately stopped at any point in the 90-minute treatment period if there is significant subject discomfort or any evidence of an adverse event. Adverse events (if any) will also be recorded and assessed.
After the treatment measurements are completed, each subject will be asked to complete a questionnaire to capture subject's therapeutic experience. The feedback obtained may be used in developing future design enhancements of the VibratoSleeve device and/or a future pivotal trial design.
After the first three of 30 scheduled therapy sessions are completed, 25 of the remaining 27 sessions may be done at either the clinic or the patient's home, based upon subject's convenience and preference. A Vibrato representative will be present for all treatments to ensure proper operation and protocol compliance. No diagnostic/perfusion measurements will be taken during at-home sessions.
A mid-treatment session (number 15 +/- 2 sessions) and the last session (number 30) will be done in identical manner to the first treatment in the clinic, including all the perfusion measurements. After the final 30th treatment, subjects will commit to 1-, 3-, and 6-month follow up visits to assess the durability of the treatment.
All 30 treatments will be done within 45 days to allow subjects the option of receiving treatments 5 days per week, over a 6-week time frame.
One-, three- and six-month follow up visits:
At each follow-up visit, the subject will receive the same diagnostic and perfusion measurements as carried out during treatment sessions:
- ABI/TBI
- Ultrasonography at calf level
- Perfusion Imaging of foot
- Adverse events (if any) will also be identified, recorded and assessed, not only for clinic visits but also for at-home treatments.
- Conditions
- Peripheral Arterial Disease (PAD)
- Being tested
- Therapeutic ultrasound (TUS)
- Keywords
- Therapeutic Ultrasound (TUS)
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ultrasound (TUS)Device
As described elsewhere, a sleeve is wrapped around the subject's targeted calf such that the inner lining with attached transducers are positioned around the calf muscle, with a gel-skin interface. The ultrasound energy is transmitted from these transducers to the deeper layers of the muscle.
| Study group | Role | What they receive |
|---|---|---|
| VibratoSleeve TUS | Experimental | Subjects will receive 30 TUS treatments, each one lasting 90 minutes on the calf of a leg with peripheral arterial disease. Receives: Device: Therapeutic ultrasound (TUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in foot perfusion
(2) Mean difference between pre-treatment (baseline) and post-treatment, and at the 1-, 3-, and 6-months post-treatment follow up visits, using Clarifi Imaging System (Modulim), which uses spatial frequency domain imaging (SFDI), to measure tissue oxygen saturation (StO2) and tissue hemoglobin (Hb) in the dermal microcirculation (HbT1) and macrocirculation (HbT2) to assess lower extremity blood supply.
Measured: Through study completion, an average of 6 months
Secondary outcomes (2)
Subject Questionnaire
Based upon subject's perceptions during treatment sessions
Measured: Through study completion, an average of 6 months.
Adverse Events
Analysis of all reported adverse events
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start14 Jan 2022
- Primary completion10 Feb 2023
- Study completionDec 2023 (estimated)
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 Disease (PAD)Studies 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 design of the VibratoSleeve TUS device.
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT05149664
- Sponsor's protocol ID
- S21-002 (Prelude Study)
- Status last verified
- May 2023
- First submitted
- 21 Oct 2021
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data summaries and study conclusions will be shared with other researchers. Individual participant data will be unshared.
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 23 May 2023. 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
- NCT05149664
- Acronym / sponsor ID
- S21-002 (Prelude Study)
- Conditions
- Peripheral Arterial Disease (PAD)
- Keywords
- Therapeutic Ultrasound (TUS)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vibrato Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Dec 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.
All evaluable subjects will receive VibratoSleeve therapeutic ultrasound (TUS) treatments. The device will be programmed to deliver TUS at a pre-determined level. Three different acoustic intensity levels will be tested during the first three treatment visits (one at each visit day). The most effective treatment that is comfortable to a subject will be prescribed for the remaining treatment sessions. Treatment time will be 90 minutes per session, one session per day. Thirty treatment sessions will be performed over a 45-day period.
Subjects will appear for on-site follow-up visits at 1-, 3-, and 6-months following subject's last (30th) treatment session.
Detailed description
Screening procedures:
Prospective participants will be recruited for participation and informed consent will be obtained after all information is presented and all questions are answered to the patient's satisfaction. Once informed consent is obtained, the study team will confirm the patient meets all inclusion criteria and no exclusion criteria.
The following is a list of all assessments and tests that are required during the screening visit.
- Medical history, demographics, and Rutherford Class, vital signs, \& circumference measurement of one calf.
- Ankle Brachial Index and Toe Brachial Index (ABI/TBI) will be measured at screening to determine eligibility and baseline values.
- Ultrasonography and Perfusion Imaging of the Foot will be undertaken prior to, during and after application of the VibratoSleeve TUS. All patients will undergo arterial duplex ultrasound at the level of the calf, ankle and/or foot to document the baseline vessel diameter, vessel velocity and volume flow. Perfusion imaging of the foot will be completed, using non-invasive methods like Flowmet by Medtronic, Inc. and Clarifi system by Modulim.
Treatments:
The initial three VibratoSleeve therapy sessions in this study will be performed at a clinical research center (VISOC).
Only subjects who have met all the inclusion criteria and none of the exclusion criteria will receive therapy. The device will be fitted and operated by Vibrato team member(s) while accompanied by site study staff. Study-related imaging will be performed by licensed vascular ultrasound technicians.
After pre-treatment imaging, Vibrato staff will fit the device to the posterior calf and couple it to skin with ultrasound gel. Therapy will be initiated using a Vibrato generator, gradually increasing acoustic output over the first 5 minutes of therapy to a nominal goal peak negative pressure, while assessing patient comfort.
During the first three 90-minute therapy sessions, ABI, TBI, ultrasonography and perfusion imaging of foot will be performed pre-treatment, during the 90-minute treatment, and immediately after the end of treatment, using identical methods to those described for screening (see above). It should be noted that ultrasound administration can be immediately stopped at any point in the 90-minute treatment period if there is significant subject discomfort or any evidence of an adverse event. Adverse events (if any) will also be recorded and assessed.
After the treatment measurements are completed, each subject will be asked to complete a questionnaire to capture subject's therapeutic experience. The feedback obtained may be used in developing future design enhancements of the VibratoSleeve device and/or a future pivotal trial design.
After the first three of 30 scheduled therapy sessions are completed, 25 of the remaining 27 sessions may be done at either the clinic or the patient's home, based upon subject's convenience and preference. A Vibrato representative will be present for all treatments to ensure proper operation and protocol compliance. No diagnostic/perfusion measurements will be taken during at-home sessions.
A mid-treatment session (number 15 +/- 2 sessions) and the last session (number 30) will be done in identical manner to the first treatment in the clinic, including all the perfusion measurements. After the final 30th treatment, subjects will commit to 1-, 3-, and 6-month follow up visits to assess the durability of the treatment.
All 30 treatments will be done within 45 days to allow subjects the option of receiving treatments 5 days per week, over a 6-week time frame.
One-, three- and six-month follow up visits:
At each follow-up visit, the subject will receive the same diagnostic and perfusion measurements as carried out during treatment sessions:
- ABI/TBI
- Ultrasonography at calf level
- Perfusion Imaging of foot
- Adverse events (if any) will also be identified, recorded and assessed, not only for clinic visits but also for at-home treatments.
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 design of the VibratoSleeve TUS device.
| Arm | Type | Receives |
|---|---|---|
| VibratoSleeve TUS | Experimental | Device: Therapeutic ultrasound (TUS)Subjects will receive 30 TUS treatments, each one lasting 90 minutes on the calf of a leg with peripheral arterial disease. |
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 3, 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 all other criteria are met).
- 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 ultrasound (TUS)As described elsewhere, a sleeve is wrapped around the subject's targeted calf such that the inner lining with attached transducers are positioned around the calf muscle, with a gel-skin interface. The ultrasound energy is transmitted from these transducers to the deeper layers of the muscle. | Device | VibratoSleeve TUS |
Primary outcome
Changes in foot perfusion
Time frame: Through study completion, an average of 6 months
(2) Mean difference between pre-treatment (baseline) and post-treatment, and at the 1-, 3-, and 6-months post-treatment follow up visits, using Clarifi Imaging System (Modulim), which uses spatial frequency domain imaging (SFDI), to measure tissue oxygen saturation (StO2) and tissue hemoglobin (Hb) in the dermal microcirculation (HbT1) and macrocirculation (HbT2) to assess lower extremity blood supply.
2 secondary outcomes
Subject Questionnaire
Time frame: Through study completion, an average of 6 months.
Adverse Events
Time frame: Through study completion, an average of 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- 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 and study conclusions will be shared with other researchers. Individual participant data will be unshared.
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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 ultrasound (TUS) in people with Peripheral Arterial Disease (PAD), 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: under way, not looking for participants, as of the sponsor's last update on 23 May 2023. 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?
This study is still under way. Results are not available in the source record yet.
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: Through study completion, an average of 6 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 NCT05149664, 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 23 May 2023.