CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
VibratoSleeve Therapeutic Ultrasound Devicedevice
Likely dose
VibratoSleeve therapeutic ultrasound applied serially to posterior calfAI-extracted
Key inclusion· 3
  • ✓Age 65 years or older
  • ✓Confirmed diagnosis of peripheral arterial disease
  • ✓Claudication symptoms classified as Rutherford class 1, 2, or 3
Key exclusion· 8
  • ✕Prior stenting in posterior tibial artery
  • ✕Revascularization procedure within 30 days before enrollment
  • ✕Ulcers, cellulitis, or skin breakdown in the posterior calf (treatment area)
  • ✕History or diagnosis of severe chronic venous insufficiency

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

Search/NCT05888740
NCT05888740N/ACompleted
CompareCT.gov

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

Vibrato Medical, Inc.·interventional·Posted Jun 5, 2023·Updated Jul 2, 2025

In Brief

A clinical study evaluating VibratoSleeve Therapeutic Ultrasound Device for Peripheral Arterial Disease. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJun 5, 2023
Enrollment StartFeb 22, 2023
Primary CompletionOct 10, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.1 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