CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
VibratoSleeve Therapeutic Ultrasound Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05145439
NCT05145439N/ACompleted
CompareCT.gov

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)

Vibrato Medical, Inc.·interventional·Posted Dec 6, 2021·Updated May 4, 2025

In Brief

A clinical study evaluating VibratoSleeve Therapeutic Ultrasound Device for Diabetic Foot Ulcer and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
CountriesUnited States
CollaboratorsVascular and Interventional Specialists of Orange County, Inc. (VISOC), National Institutes of Health (NIH)

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 6, 2021
Enrollment StartJan 14, 2023
Primary CompletionNov 10, 2023
Study CompletionDec 13, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.6 years ago

Interventions

VibratoSleeve Therapeutic Ultrasound Devicedevice

The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf.