Abstract
We present a robust, cost-effective (<2000 USD), and portable optical diffuse speckle pulsatile flowmetry (DSPF) device with a flexible handheld probe for deep tissue blood flow measurement in the human foot as well as a first-in-man observational clinical study using the proposed optical device for tissue ischemia assessment and peripheral artery disease (PAD) diagnosis. Blood flow in tissue is inherently pulsatile in nature. However, most conventional methods cannot measure deep tissue-level pulsatile blood flow noninvasively. The proposed optical device can measure tissue-level pulsatile blood flow ∼6 mm underneath the skin surface. A new quantitative tissue perfusion index (TPI(DSPF)) based on frequency domain analysis of the pulsatile blood flow waveform is defined to assess tissue ischemia status. Through a clinical study involving 66 subjects, including healthy individuals and diabetes patients with and without PAD, TPI(DSPF) demonstrated strong correlations of 0.720 with transcutaneous tissue partial oxygen pressure (TcPO2) and 0.652 with toe-brachial index (TBI). Moreover, among the three methods, TPI(DSPF) demonstrated the highest area under the curve for PAD diagnosis among diabetes patients, with a notable value of 0.941. The promising clinical results suggest that the proposed optical method has the potential to be an effective clinical tool for identifying PAD among the diabetic cohort.