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

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot

Intervention / Treatment
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* Device: VibratoSleeve Therapeutic Ultrasound Device


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single arm, open-label, feasibility acute phase study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VibratoSleeve TUS<br>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<br>* The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcutaneous Oxygen Pressure (TcPO2) | TcPO2 is a 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 |
| --- | --- | --- |
| Perfusion rate of the targeted foot | Perfusion to be measured with the FlowMet Device (Medtronic) | Through study completion, an average of 1 month | 
| DFU tissue oxygenation (StO2) and the hemoglobin content (HbT2) | To be measured with the Clarifi device (Modulim) | Through study completion, an average of 1 month | 
| Ankle Brachial Index (ABI) | per institutional standards of care | Through study completion, an average of 1 month |