NCT05888740

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Vibrato Medical, Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-22
• Primary completion: 2024-10-10
• Completion: 2024-10-10
• First posted: 2023-06-05
• Last updated: 2025-07-02
• Results posted: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study