Trial Outcomes & Findings for Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD) (NCT NCT05888740)

NCT ID: NCT05888740

Last Updated: 2025-07-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline to end of treatment, an average of 1 month
• Results posted on: 2025-07-02

Participant Flow

Participant milestones

Measure	TUS Therapy These subjects will undergo treatments with the Vibrato Sleeve TUS 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
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	TUS Therapy n=12 Participants These subjects will undergo treatments with the Vibrato Sleeve TUS 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	72.1 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to end of treatment, an average of 1 month

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

Outcome measures

Measure	TUS Therapy n=12 Participants These subjects will undergo treatments with the Vibrato Sleeve TUS 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
Mean Acute Flow Rate Difference During TUS Treatment Sessions	27.3 Percent change (%) Standard Deviation 50.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	TUS Therapy n=12 Participants These subjects will undergo treatments with the Vibrato Sleeve TUS 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
Tissue Oxygen Saturation (StO2)	1.0 StO2% Standard Deviation 8.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	TUS Therapy n=12 Participants These subjects will undergo treatments with the Vibrato Sleeve TUS 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
Ankle Brachial Index (ABI)	0.0 Index (Ratio) Standard Deviation 0.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	TUS Therapy n=12 Participants These subjects will undergo treatments with the Vibrato Sleeve TUS 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
Incidence of Device and Procedure-related Adverse Events	0 Events

Adverse Events

TUS Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President of Clinical Affairs

Vibrato Medical

Phone: 2139215088

Email: bisrat@vibratomedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institution and Investigator shall have the right to publish data obtained from the Study provided that the Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for written approval, for which approval shall not be unreasonably denied. Sponsor reserves the right to delete any Confidential Information or other proprietary information of Sponsor (including trade secrets but not including Results) from the proposed publication or presentation.
• Publication restrictions are in place

Restriction type: OTHER