ObjectiveWe compared the screening capabilities of the BlueDop Vascular Expert (BVE) and ankle-brachial index (ABI) in peripheral arterial disease for all-comer patients and those with diagnosed diabetes mellitus (DM). MethodsData were collected retrospectively and prospectively at a single center in 104 all-comers from BVE and ABI compared with conventional full leg arterial duplex on the same patient, same limb, and at the same appointment. A final comparison was made between the BVE and ABI using full leg arterial duplex as the diagnostic comparison. 104 all-comers were included, and 35 of those patients had diagnosed DM. ResultsFor all-comers, BVE sensitivity was 90%, specificity was 96%, accuracy was 94.5%, and κ = 0.84. In contrast, ABI sensitivity was 53%, specificity was 95%, accuracy was 86%, and κ = 0.53. Of the 35 patients with DM, BVE screened 65 limbs and ABI screened 63 limbs. For patients with DM, BVE sensitivity was 90%, specificity was 98%, accuracy was 95.4%, and κ = 0.89. In contrast, ABI sensitivity was 40%, specificity was 81%, accuracy was 68.3%, and κ = 0.23. ConclusionsThe need for a device that is easy to use, easy to interpret, portable, and, most important, accurate, is critical in reducing long-term complications of peripheral artery disease. As a cuffless arterial assessment system, the BVE was found to have superior sensitivity, specificity, and accuracy when compared with ABI in all-comers. In patients with DM, BVE also showed greater sensitivity, specificity, and notably an accuracy of 95.4% compared with ABI's accuracy of 68.3%. The data support that BVE is an accurate and easy-to-use lower limb blood flow assessment device, even when assessing the most challenging patients.