Prospective Assessment of Lower-Extremity Peripheral Arterial Disease in Diabetic Patients Using a Novel Automated Optical Device

Abstract

A new optical device based on the photoplethysmograph (PPG) method and an innovative algorithm for the assessment of lower-extremity peripheral arterial disease was investigated prospectively in patients with type II diabetes. This new functional PPG (fPPG) technique uses a cuffless functional test to assess diabetic peripheral arterial disease without operator dependency and the incompressible arteries, issues associated with ankle brachial pressure index (ABPI) measurement. Diabetic patients (n = 24; 47 legs; age, 70 ± 3 years) were recruited from the vascular clinic, and controls (n = 15; 30 legs; age, 66 ± 5 years) were recruited from the orthopedic outpatient clinic. All underwent resting ABPI, fPPG, and duplex angiography (DA) as “gold standard.” fPPG requires the placement of an optical probe on the toe for acquisition of pulsatile arterial perfusion for a period of 30 seconds with the leg in supine and raised at 45° positions. The data were analyzed, and indices were generated by an automated computer system. In those with diabetes, fPPG correlated significantly with DA (r = −.68, P < .01) and ABPI (r = −.65, P < .01). We also found a significant correlation between ABPI and DA (r = .81, P < .01). The analysis of the receiver operator curve showed that optimum sensitivity and specificity for ABPI and fPPG were 80% and 93% and 83% and 71%, respectively, against DA. This method uses changes in pulsatile arterial blood volume using a simple cuffless functional test. The fPPG investigation period was much shorter (5 minutes) with independence of operator skills, whereas ABPI took longer (10-15 minutes) and required operator experience. Although the fPPG results are promising, further improvement (eg, by incorporation of functional skin color and temperature changes) is required to improve the sensitivity and specificity of the system.