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

Not Applicable

Active, not recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Therapeutic Device

• Registration Number: NCT05100745
• Lead Sponsor: Vibrato Medical, Inc.

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.

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-10-29
• Study Start: 2023-03-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age ≥22.
2. Diagnosis of infrapopliteal PAD.
3. Rutherford class 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. Ongoing hyperbaric oxygen treatment (HBOT)

9. 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.

10. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Activated Therapy	Therapeutic Device	Therapy: these subjects will undergo 30 treatments with an activated Vibratosleeve TUS device.
Sham Therapy	Therapeutic 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.

Primary Outcome Measures

Name	Time	Method
Changes in foot perfusion	4 months	Mean difference between pre-treatment (baseline) and/or last sham treatment with post-treatment measurements, including the 2-month follow-up.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	up to and including the 2-month follow-up visit for test and control subjects.	Analysis of all reported device-related adverse events throughout each subject's participation.
Subject Questionnaire	up to and including the 2-month follow-up visit for test and control subjects.	Questions will be based on each treatment session and what each subject felt and observed.

Trial Locations

Locations (1)

Vascular & Interventional Specialists of Orange County; 🇺🇸 Orange, California, United States