Who is sponsoring NCT05888740?

NCT05888740 is sponsored by Vibrato Medical, Inc..

What drugs are being tested in NCT05888740?

Interventions in NCT05888740: VibratoSleeve Therapeutic Ultrasound Device.

What condition does NCT05888740 study?

NCT05888740 studies Peripheral Arterial Disease.

Is NCT05888740 still recruiting?

NCT05888740 is currently completed. Last updated 2 July 2025.

Are results published for NCT05888740?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-02 · How we verify

NCT05888740: Waltz

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)

Completed NA Results posted Last updated 2 July 2025

What this trial tests

NA trial testing VibratoSleeve Therapeutic Ultrasound Device in Peripheral Arterial Disease in 12 participants. Completed in 10 October 2024.

Timeline

22 February 2023

Primary endpoint
10 October 2024

10 October 2024

Quick facts

Lead sponsor	Vibrato Medical, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	22 February 2023
Primary completion	10 October 2024
Estimated completion	10 October 2024
Sites	1 location across United States

Drugs / interventions tested

VibratoSleeve Therapeutic Ultrasound Device

Conditions studied

Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

Vibrato Medical, Inc.

Who can join

65 and older, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Acute Flow Rate Difference During TUS Treatment Sessions Primary · Baseline to end of treatment, an average of 1 month

Percent change in perfusion measured by FlowMet calculated between baseline and after final treatment.

Group	Value	95% CI
TUS Therapy	27.3	± 50.8

Tissue Oxygen Saturation (StO2) Primary · Through study completion, an average of 1 month

Calculate changes in tissue oxygen saturation (StO2) measured non-invasively by Clarifi spatial frequency domain imaging system, compared from baseline to during and immediately post-treatment.

Group	Value	95% CI
TUS Therapy	1.0	± 8.4

Ankle Brachial Index (ABI) Primary · Baseline to end of treatment, an average of 1 month

ABI is ratio that compares blood pressure in the arm to blood pressure in the ankle. It is a measurement of the extent of peripheral arterial disease.

Group	Value	95% CI
TUS Therapy	0.0	± 0.12

Incidence of Device and Procedure-related Adverse Events Secondary · Through study completion, an average of 1 month

Number of adverse events related to the VibratoSleeve device or study procedure occurring throughout the duration of the study.

Group	Value	95% CI
TUS Therapy	0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Ultrasound-driven atherosclerosis nanomedicine: from mechanical, cavitation, and sonodynamic therapies to bedside translation.
Shao Y, Luo J, Tu S, Xie Y, et al · · 2025 · cited 1× · PMID 41351120 · DOI 10.1186/s12951-025-03857-2

Verify or expand the search:

Other trials of VibratoSleeve Therapeutic Ultrasound Device

Trials testing the same drug.

NCT05145439 — A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers. · NA · completed

Other recruiting trials for Peripheral Arterial Disease

Currently open trials in the same condition.

NCT05437562 — Randomized Clinical Trial for Ewing Amputation in the VA · NA · recruiting
NCT07427108 — Road Mapping Guided Puncture Versus Ultrasound Guided Puncture During Retrograde Angioplasty Feasibility and Safety · NA · recruiting
NCT07336381 — Replexa+ Shortwave Diathermy Device for Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy · NA · recruiting
NCT07076082 — Vascular Trial Associated Registry Pilot · Phase 4 · recruiting
NCT06308562 — Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease · NA · recruiting

Other Vibrato Medical, Inc. trials

Trials by the same sponsor.

NCT05100745 — A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD · NA · completed
NCT05145439 — A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers. · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05888740 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vibrato Medical, Inc.
Last refreshed: 2 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05888740.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing