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

NCT05888740 | Completed Results FDA Device

• 1 other identifier: 022-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Mean Acute Flow Rate Difference During TUS Treatment Sessions

  Percent change in perfusion measured by FlowMet calculated between baseline and after final treatment.

  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.

  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.

  Baseline to end of treatment, an average of 1 month

Secondary Outcomes (1)

• Incidence of Device and Procedure-related Adverse Events

  Through study completion, an average of 1 month

Study Arms (1)

TUS Therapy

EXPERIMENTAL

These subjects will undergo treatments with the Vibrato Sleeve TUS device.

Device: VibratoSleeve Therapeutic Ultrasound Device

Interventions

VibratoSleeve Therapeutic Ultrasound Device DEVICE

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

TUS Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vibrato Medical, Inc.: lead

Study Sites (1)

Vascular & Interventional Specialists of Orange County

Orange, California, 92868, United States

Location

Related Publications (1)

• 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.

  PMID: 26062950 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Results Point of Contact

• Title: Vice President of Clinical Affairs
• Organization: Vibrato Medical

bisrat@vibratomedical.com

2139215088

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single arm, open-label, feasibility acute phase study

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: February 22, 2023
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: July 2, 2025
• Results First Posted: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)