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

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Diabetic Foot Ulcer; Wound; Foot
• Intervention / Treatment: Device: VibratoSleeve Therapeutic Ultrasound Device

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Vascular & Interventional Specialists of Orange County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Presence of at least one DFU (grade 0 or 1 by University of Texas classification)
2. Diagnosis of diabetes mellitus

3. Diagnosis of PAD that meets at least one of the following conditions:

   1. Ankle-brachial index (ABI) of < 0.9 in the same limb as the DFU
   2. Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg
   3. Documented history of PAD for a minimum of 3 calendar months prior to time of enrollment
4. Aged ≥ 22 years

Exclusion Criteria:

1. Rutherford 6 stage PAD
2. Active DFU infection
3. End-stage renal disease on dialysis
4. HbA1c > 13%.
5. Planned PAD revascularization.
6. Prior stenting in posterior tibial artery.
7. 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).
8. History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
9. Acute limb ischemia within 30 days prior to treatment.
10. History or diagnosis of deep venous thrombosis below the knee in treatment leg.
11. 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.
12. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VibratoSleeve TUS; 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, an average of 1 month
Tissue Oxygen Saturation (StO2)	spatial frequency domain imaging (SFDI) to measure tissue oxygen saturation	Through study completion, an average of 1 month
Ankle Brachial Index (ABI)	blood pressure ratio in the upper arm and lower limbs	Through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: Vibrato Medical, Inc.
• Collaborators: National Institutes of Health (NIH); Vascular and Interventional Specialists of Orange County, Inc. (VISOC)

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2023
• Primary Completion (Actual): November 10, 2023
• Study Completion (Actual): December 13, 2023

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Ulcer; Diabetic Foot; Foot Ulcer; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: S21-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes