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

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).