This study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (PAD) patients 65 years of age and over.
The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in subjects with early stage PAD. Each subject will receive TUS treatment multiple 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf
Vascular & Interventional Specialists of Orange County
Orange, California, United States
Mean Acute Flow Rate Difference During TUS Treatment Sessions
Percent change in perfusion measured by FlowMet calculated between baseline and after final treatment.
Time frame: Baseline to end of treatment, an average of 1 month
Tissue Oxygen Saturation (StO2)
Calculate changes in tissue oxygen saturation (StO2) measured non-invasively by Clarifi spatial frequency domain imaging system, compared from baseline to during and immediately post-treatment.
Time frame: Through study completion, an average of 1 month
Ankle Brachial Index (ABI)
ABI is ratio that compares blood pressure in the arm to blood pressure in the ankle. It is a measurement of the extent of peripheral arterial disease.
Time frame: Baseline to end of treatment, an average of 1 month
Incidence of Device and Procedure-related Adverse Events
Number of adverse events related to the VibratoSleeve device or study procedure occurring throughout the duration of the study.
Time frame: Through study completion, an average of 1 month
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