Diabetic Foot UlcerDulcetNCT05145439

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

A study testing VibratoSleeve Therapeutic Ultrasound Device in people with Diabetic Foot Ulcer and Peripheral Arterial Disease, run by Vibrato Medical, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 22 years and older
Conditions the study is for: Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
What is being tested?: VibratoSleeve Therapeutic Ultrasound Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 14 Jan 2023to 13 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Presence of at least one DFU (grade 0 or 1 by University of Texas classification)
Diagnosis of diabetes mellitus
Diagnosis of PAD that meets at least one of the following conditions:
Ankle-brachial index (ABI) of < 0.9 in the same limb as the DFU
Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg
Documented history of PAD for a minimum of 3 calendar months prior to time of enrollment
Aged ≥ 22 years

Who cannot join

Rutherford 6 stage PAD
Active DFU infection
End-stage renal disease on dialysis
HbA1c > 13%.
Planned PAD revascularization.
Prior stenting in posterior tibial artery.

Show all 12Show fewer

Re-vascularization procedure within 25 days prior to enrollment in the study. (Note: Patients who had re-vascularization procedure earlier than 25 days prior to enrollment are eligible for enrollment if they meet all other criteria).
History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
Acute limb ischemia within 30 days prior to treatment.
History or diagnosis of deep venous thrombosis below the knee in treatment leg.
Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study or lead to difficulties for patient compliance with study requirements, or could confound study data.
Patient's enrollment in another investigational study that has not completed the required primary endpoint follow-up period (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study).

Trial locations and contacts

1 site in 1 country.

United States1 site

Vascular & Interventional Specialists of Orange County
Orange, California, 92868

Other trials in United States

About this study

Official title: A Non-significant Risk Clinical Study to Assess Changes in Perfusion, Oxygenation, and Hemoglobin Content After Application of the VibratoSleeve, a Therapeutic Ultrasound (TUS) Phased Array, for Patients With Ischemic and Neuroischemic Diabetic Foot Ulcers (DFU)

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

Read the detailed description

The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in diabetic subjects with PAD and DFU. Each subject will receive one 90-minute TUS treatment in each of 3 treatment sessions. All post-treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.

Conditions: Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
Being tested: VibratoSleeve Therapeutic Ultrasound Device
Medical subject headings: Diabetic Foot, Peripheral Arterial Disease, Foot Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VibratoSleeve Therapeutic Ultrasound DeviceDevice
The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf.

Study groups in NCT05145439
Study group	Role	What they receive
VibratoSleeve TUS	Experimental	In this single arm study, there is only one group/arm, all of whom will be given 3 levels of treatment with the VibratoSleeve TUS device. Receives: Device: VibratoSleeve Therapeutic Ultrasound Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Transcutaneous Oxygen Pressure (TcPO2)
noninvasive test that directly measures the oxygen level of tissue beneath the skin
Measured: Through study completion, an average of 1 month.

Secondary outcomes (3)

Percent Change From Baseline in Perfusion Rate of the Targeted Foot
Calculate percent change in perfusion rate measured non-invasively by Flowmet, compared from baseline to end of treatment.
Measured: Through study completion, an average of 1 month
Tissue Oxygen Saturation (StO2)
spatial frequency domain imaging (SFDI) to measure tissue oxygen saturation
Measured: Through study completion, an average of 1 month
Ankle Brachial Index (ABI)
blood pressure ratio in the upper arm and lower limbs
Measured: Through study completion, an average of 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 202313 Dec 2023

First posted6 Dec 2021
Study start14 Jan 2023
Primary completion10 Nov 2023
Study completion13 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective, single arm, open-label, feasibility acute phase study
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05145439
Sponsor's protocol ID: S21-003
Acronym: Dulcet
Status last verified: Apr 2025
First submitted: 10 Nov 2021
Last updated: 4 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Collective (analyzed) study data will be published with an exception of discussing an individual subject's outcomes (anonymized) that contribute to a better understanding of the treatment.

Publications

Yang C, Weng H, Chen L, Yang H, Luo G, Mai L, Jin G, Yan L. Transcutaneous oxygen pressure measurement in diabetic foot ulcers: mean values and cut-point for wound healing. J Wound Ostomy Continence Nurs. 2013 Nov-Dec;40(6):585-9. doi: 10.1097/WON.0b013e3182a9a7bf.
PubMed 24202221
Kalani M, Brismar K, Fagrell B, Ostergren J, Jorneskog G. Transcutaneous oxygen tension and toe blood pressure as predictors for outcome of diabetic foot ulcers. Diabetes Care. 1999 Jan;22(1):147-51. doi: 10.2337/diacare.22.1.147.
PubMed 10333917

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Diabetic Foot Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-significant Risk Clinical Study to Assess Changes in Perfusion, Oxygenation, and Hemoglobin Content After Application of the VibratoSleeve, a Therapeutic Ultrasound (TUS) Phased Array, for Patients With Ischemic and Neuroischemic Diabetic Foot Ulcers (DFU)
ClinicalTrials.gov ID: NCT05145439
Acronym / sponsor ID: Dulcet / S21-003
Conditions: Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Vibrato Medical, Inc.Industry (pharma, biotech, devices)
Collaborators: Vascular and Interventional Specialists of Orange County, Inc. (VISOC), National Institutes of Health (NIH)
Study start: 14 Jan 2023 (actual)
Primary completion: 10 Nov 2023 (actual)
Study completion: 13 Dec 2023 (actual)
First posted: 6 Dec 2021 (actual)
Results: Posted 4 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, single arm, open-label, feasibility acute phase study

Arm	Type	Receives
VibratoSleeve TUS	Experimental	Device: VibratoSleeve Therapeutic Ultrasound DeviceIn this single arm study, there is only one group/arm, all of whom will be given 3 levels of treatment with the VibratoSleeve TUS device.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Presence of at least one DFU (grade 0 or 1 by University of Texas classification)
Diagnosis of diabetes mellitus
Diagnosis of PAD that meets at least one of the following conditions:
Aged ≥ 22 years

Key exclusion criteria (12 listed)

Rutherford 6 stage PAD
Active DFU infection
End-stage renal disease on dialysis
HbA1c > 13%.
Planned PAD revascularization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VibratoSleeve Therapeutic Ultrasound DeviceThe VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf.	Device	VibratoSleeve TUS

Primary outcome

Transcutaneous Oxygen Pressure (TcPO2)
Time frame: Through study completion, an average of 1 month.
noninvasive test that directly measures the oxygen level of tissue beneath the skin

3 secondary outcomes

Percent Change From Baseline in Perfusion Rate of the Targeted Foot
Time frame: Through study completion, an average of 1 month
Tissue Oxygen Saturation (StO2)
Time frame: Through study completion, an average of 1 month
Ankle Brachial Index (ABI)
Time frame: Through study completion, an average of 1 month

Results and safety

Results posted to the registry on 4 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VibratoSleeve TUS	12	12

Primary outcome: Transcutaneous Oxygen Pressure (TcPO2)

Time frame: Through study completion, an average of 1 month.. Mean (Standard Deviation). Unit: mmHg

Measure	VibratoSleeve TUS n = 12
Value	50.96 (17.40)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety surveillance and reporting starts when subject receives therapy with the VibratoSleeve until the end of the final treatment visit. All treatment visits were completed within an average of 1 month per patient.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VibratoSleeve TUS	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24202221Yang C, Weng H, Chen L, Yang H, Luo G, Mai L, Jin G, Yan L. Transcutaneous oxygen pressure measurement in diabetic foot ulcers: mean values and cut-point for wound healing. J Wound Ostomy Continence Nurs. 2013 Nov-Dec;40(6):585-9. doi: 10.1097/WON.0b013e3182a9a7bf.
Results publication: PubMed 10333917Kalani M, Brismar K, Fagrell B, Ostergren J, Jorneskog G. Transcutaneous oxygen tension and toe blood pressure as predictors for outcome of diabetic foot ulcers. Diabetes Care. 1999 Jan;22(1):147-51. doi: 10.2337/diacare.22.1.147.
Individual participant dataSharing planned: No. Collective (analyzed) study data will be published with an exception of discussing an individual subject's outcomes (anonymized) that contribute to a better understanding of the treatment.

Related trials for Diabetic Foot Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VibratoSleeve Therapeutic Ultrasound Device in people with Diabetic Foot Ulcer and Peripheral Arterial Disease, run by Vibrato Medical, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transcutaneous Oxygen Pressure (TcPO2) (time frame: Through study completion, an average of 1 month.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05145439, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.