NCT05145439: Dulcet

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

Completed NA Results posted Last updated 4 May 2025

What this trial tests

NA trial testing VibratoSleeve Therapeutic Ultrasound Device in Diabetic Foot Ulcer in 12 participants. Completed in 13 December 2023.

Timeline

14 January 2023

Primary endpoint
10 November 2023

13 December 2023

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	14 January 2023
Primary completion	10 November 2023
Estimated completion	13 December 2023
Sites	1 location across United States

Drugs / interventions tested

• VibratoSleeve Therapeutic Ultrasound Device

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
• Wound; Foot — all drugs for Wound; Foot →

Sponsor

Vibrato Medical, Inc.

Who can join

22 and older, any sex, with Diabetic Foot Ulcer or 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.

Transcutaneous Oxygen Pressure (TcPO2) Primary · Through study completion, an average of 1 month.

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

Group	Value	95% CI
VibratoSleeve TUS	50.96	± 17.40

Percent Change From Baseline in Perfusion Rate of the Targeted Foot Secondary · 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.

Group	Value	95% CI
VibratoSleeve TUS	34	± 4.6

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

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

Group	Value	95% CI
VibratoSleeve TUS	76.0	± 17.2

Ankle Brachial Index (ABI) Secondary · Through study completion, an average of 1 month

blood pressure ratio in the upper arm and lower limbs

Group	Value	95% CI
VibratoSleeve TUS	0.92	± 0.026

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.