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

Peripheral Arterial Disease Clinical Trial

— Waltz  

Official title:

A Prospective, Non-significant Risk, Feasibility Study to Evaluate Serial Applications of VibratoSleeve Therapy to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD) Subjects 65 Years of Age and Older

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888740
• Other study ID #: 022-01
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Vibrato Medical, Inc.
• Contact: Bisrat Woldemichael
• Phone: 213-921-0588
• Email: bisrat[@]vibratomedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in subjects with early stage PAD. Each subject will receive TUS treatment multiple sessions. All post- treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Age = 65

2. Diagnosis of PAD.

3. Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator.

Exclusion Criteria:

1. Prior stenting in posterior tibial artery.

2. Re-vascularization procedure within 30 days prior to enrollment in the study.

3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).

4. History or diagnosis of severe chronic venous insufficiency.

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. 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.

8. Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period. stenting in posterior tibial artery.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• VibratoSleeve Therapeutic Ultrasound Device
The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf

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	Mean acute flow rate difference during TUS treatment sessions	Quantify perfusion rate	Through study completion, an average of 1 month
Primary	Tissue oxygen saturation (StO2)	Assess oxygenation	Through study completion, an average of 1 month
Primary	Ankle Brachial Index	Ankle brachial indices to assess the difference in blood pressure in the upper arm and lower limbs	Through study completion, an average of 1 month
Secondary	Safety Endpoint	Device and procedure related adverse events	Through study completion, an average of 1 month