NCT05145439

A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.

A Non-significant Risk Clinical Study to Assess Changes in Perfusion, Oxygenation, and Hemoglobin Content After Application of the VibratoSleeve, a Therapeutic Ultrasound (TUS) Phased Array, for Patients With Ischemic and Neuroischemic Diabetic Foot Ulcers (DFU)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Vibrato Medical, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).

Detailed description

The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in diabetic subjects with PAD and DFU. Each subject will receive one 90-minute TUS treatment in each of 3 treatment 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

• Diabetic Foot Ulcer
• Peripheral Arterial Disease
• Wound; Foot

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: 2023-01-14
• Primary completion: 2023-11-10
• Completion: 2023-12-13
• First posted: 2021-12-06
• Last updated: 2025-05-04
• Results posted: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study