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

Not Applicable

Completed

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.

Recruitment & Eligibility

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:
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
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).

Arm && Interventions

Group	Intervention	Description
VibratoSleeve TUS	VibratoSleeve Therapeutic Ultrasound Device	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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