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

NCT05145439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-04

Study results available
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Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Vascular and Interventional Specialists of Orange County, Inc. (VISOC)

    collaborator UNKNOWN

  • National Institutes of Health (NIH)

    collaborator NIH

  • Vibrato Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-14
Primary Completion
2023-11-10
Completion
2023-12-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05145439 on ClinicalTrials.gov