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

NCT05100745 | Completed DMC FDA Device

• 1 other identifier: 21-001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Arterial Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (2)

• Adverse Events

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

• Subject Questionnaire

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

Study Arms (2)

Activated Therapy

EXPERIMENTAL

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

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.

Device: Therapeutic Device

Interventions

Therapeutic Device DEVICE

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

Also known as: VibratoSleeve TUS Device

Activated Therapy; Sham Therapy

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. 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).

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: October 29, 2021
• Study Start: March 13, 2023
• Primary Completion: May 31, 2024
• Study Completion: December 11, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)