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

Peripheral Arterial Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100745
• Other study ID #: 21-001
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Vibrato Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

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).

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Therapeutic Device
This device delivers ultrasound energy to the targeted area of the lower limb.

Locations

Country	Name	City	State
United States	Vascular & Interventional Specialists of Orange County	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Vibrato Medical, Inc.

Country where clinical trial is conducted

United States, 

References & 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 201 — View Citation

Outcome

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