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

Primary Purpose

Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

VibratoSleeve Therapeutic Ultrasound Device

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Presence of at least one DFU (grade 0 or 1 by University of Texas classification).8,9
Diagnosis of diabetes mellitus.
Diagnosis of PAD.
Ankle-brachial index (ABI) of < 0.9 in the same limb as the DFU.
Aged ≥ 22 years.

Exclusion Criteria:

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

NOTE: Eligibility for patients with bi-lateral PAD will be assessed based on the leg that has more advanced PAD and DFU. For bi-lateral PAD patients only one leg with the more disease will be treated.

Sites / Locations

Vascular & Interventional Specialists of Orange County

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VibratoSleeve TUS

Arm Description

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.

Outcomes

Primary Outcome Measures

Transcutaneous Oxygen Pressure (TcPO2)

TcPO2 is a noninvasive test that directly measures the oxygen level of tissue beneath the skin.

Secondary Outcome Measures

Perfusion rate of the targeted foot

Perfusion to be measured with the FlowMet Device (Medtronic)

DFU tissue oxygenation (StO2) and the hemoglobin content (HbT2)

To be measured with the Clarifi device (Modulim)

Ankle Brachial Index (ABI)

per institutional standards of care

Full Information

NCT ID

NCT05145439

First Posted

November 10, 2021

Last Updated

May 23, 2023

Sponsor

Vibrato Medical, Inc.

Collaborators

Vascular and Interventional Specialists of Orange County, Inc. (VISOC), National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT05145439

Brief Title

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

Acronym

Dulcet

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 14, 2023 (Actual)

Primary Completion Date

September 14, 2023 (Anticipated)

Study Completion Date

December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vibrato Medical, Inc.

Collaborators

Vascular and Interventional Specialists of Orange County, Inc. (VISOC), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, single arm, open-label, feasibility acute phase study

Masking

None (Open Label)

Masking Description

Though the treatment device will be known to all participants, the level of treatment will be randomized among 3 distinct sessions and the level of treatment will be masked for the subject (participant), care provider, investigator, and outcomes assessor.

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VibratoSleeve TUS

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

VibratoSleeve Therapeutic Ultrasound Device

Intervention Description

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

Primary Outcome Measure Information:

Title

Transcutaneous Oxygen Pressure (TcPO2)

Description

TcPO2 is a noninvasive test that directly measures the oxygen level of tissue beneath the skin.

Time Frame

Through study completion, an average of 1 month.

Secondary Outcome Measure Information:

Title

Perfusion rate of the targeted foot

Description

Perfusion to be measured with the FlowMet Device (Medtronic)

Time Frame

Through study completion, an average of 1 month

Title

DFU tissue oxygenation (StO2) and the hemoglobin content (HbT2)

Description

To be measured with the Clarifi device (Modulim)

Time Frame

Through study completion, an average of 1 month

Title

Ankle Brachial Index (ABI)

Description

per institutional standards of care

Time Frame

Through study completion, an average of 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Vascular & Interventional Specialists of Orange County

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

24202221

Citation

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.

Results Reference

result

PubMed Identifier

10333917

Citation

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.

Results Reference

result

Learn more about this trial

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

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