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A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD (Concerto)

Primary Purpose

Peripheral Arterial Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Therapeutic Device

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Therapeutic Ultrasound (TUS), Peripheral Artery Disease (PAD), Critical Limb Ischemia (CLI)

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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 more advanced bi-lateral PAD will be treated.

Sites / Locations

Vascular & Interventional Specialists of Orange CountyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Activated Therapy

Sham Therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse Events

Analysis of all reported device-related adverse events throughout each subject's participation.

Subject Questionnaire

Questions will be based on each treatment session and what each subject felt and observed.

Full Information

NCT ID

NCT05100745

First Posted

October 21, 2021

Last Updated

May 23, 2023

Sponsor

Vibrato Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05100745

Brief Title

A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD

Acronym

Concerto

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 13, 2023 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vibrato Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

Keywords

Therapeutic Ultrasound (TUS), Peripheral Artery Disease (PAD), Critical Limb Ischemia (CLI)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Prospective, double-blinded, randomized controlled trial to evaluate the feasibility of TUS in the treatment of PAD.

Masking

ParticipantCare ProviderInvestigator

Masking Description

Clinicians and subjects in both the active and sham group will be blinded to the randomized treatment assignments until 2-month follow-up visit. The sham and active devices will appear the same and appear to be utilized in the same manner. Only the Vibrato Medical person controlling the treatment device will be aware of the respective randomization for each subject. The second phase of this study, crossing over from sham to active treatment will not be concealed.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Activated Therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Sham Therapy

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Therapeutic Device

Other Intervention Name(s)

VibratoSleeve TUS Device

Intervention Description

This device delivers ultrasound energy to the targeted area of the lower limb.

Primary Outcome Measure Information:

Title

Changes in foot perfusion

Description

Mean difference between pre-treatment (baseline) and/or last sham treatment with post-treatment measurements, including the 2-month follow-up.

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Analysis of all reported device-related adverse events throughout each subject's participation.

Time Frame

up to and including the 2-month follow-up visit for test and control subjects.

Title

Subject Questionnaire

Description

Questions will be based on each treatment session and what each subject felt and observed.

Time Frame

up to and including the 2-month follow-up visit for test and control subjects.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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).

Facility Information:

Facility Name

Vascular & Interventional Specialists of Orange County

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raj Khalsa, MD

Phone

714-598-1194

info@visoc.org

First Name & Middle Initial & Last Name & Degree

Raj Khalsa, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data summaries, group outcomes, and study conclusions will be shared with other researchers. Individual participant data will not be shared.

Citations:

PubMed Identifier

26062950

Citation

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.

Results Reference

result

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A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD

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