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

Peripheral Arterial Disease Clinical Trial

Official title:
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)

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05145439
Study type Interventional
Source Vibrato Medical, Inc.
Contact
Status Completed
Phase N/A
Start date January 14, 2023
Completion date December 13, 2023
View Details
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