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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
Sponsored by
Vibrato Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  1. Age ≥22.
  2. Diagnosis of infrapopliteal PAD.
  3. Rutherford class 3, 4 or 5 as determined by the investigator.
  4. Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg.

Exclusion Criteria:

  1. Prior stenting in posterior tibial, anterior tibial or peroneal artery.
  2. 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).
  3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
  4. History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
  5. Acute limb ischemia within 30 days prior to treatment.
  6. History or diagnosis of deep venous thrombosis below the knee in treatment leg.
  7. Uncontrolled diabetes defined as HbA1c greater than 10%.
  8. 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).

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

First Posted
October 21, 2021
Last Updated
May 23, 2023
Sponsor
Vibrato Medical, Inc.
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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
No
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
No
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
Email
info@visoc.org
First Name & Middle Initial & Last Name & Degree
Raj Khalsa, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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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