Trial Outcomes & Findings for A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers. (NCT NCT05145439)

NCT ID: NCT05145439

Last Updated: 2025-05-04

Results Overview

noninvasive test that directly measures the oxygen level of tissue beneath the skin

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Through study completion, an average of 1 month.
• Results posted on: 2025-05-04

Participant Flow

Participant milestones

Measure	VibratoSleeve TUS Received treatment with the VibratoSleeve TUS device.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	VibratoSleeve TUS n=12 Participants Received treatment with the VibratoSleeve TUS device.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Transcutaneous oxygen pressure (TcPO2)	67.54 mmHg STANDARD_DEVIATION 17.68 • n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 1 month.

noninvasive test that directly measures the oxygen level of tissue beneath the skin

Outcome measures

Measure	VibratoSleeve TUS n=12 Participants Received treatment with the VibratoSleeve TUS device.
Transcutaneous Oxygen Pressure (TcPO2)	50.96 mmHg Standard Deviation 17.40

SECONDARY outcome

Timeframe: Through study completion, an average of 1 month

Calculate percent change in perfusion rate measured non-invasively by Flowmet, compared from baseline to end of treatment.

Outcome measures

Measure	VibratoSleeve TUS n=12 Participants Received treatment with the VibratoSleeve TUS device.
Percent Change From Baseline in Perfusion Rate of the Targeted Foot	34 Percentage (%) Standard Deviation 4.6

SECONDARY outcome

Timeframe: Through study completion, an average of 1 month

spatial frequency domain imaging (SFDI) to measure tissue oxygen saturation

Outcome measures

Measure	VibratoSleeve TUS n=12 Participants Received treatment with the VibratoSleeve TUS device.
Tissue Oxygen Saturation (StO2)	76.0 Percentage (%) Standard Deviation 17.2

SECONDARY outcome

Timeframe: Through study completion, an average of 1 month

blood pressure ratio in the upper arm and lower limbs

Outcome measures

Measure	VibratoSleeve TUS n=12 Participants Received treatment with the VibratoSleeve TUS device.
Ankle Brachial Index (ABI)	0.92 ratio Standard Deviation 0.026

Adverse Events

VibratoSleeve TUS

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