Background: The objective of this study was to assess the ability of a novel, automated Conformité Européenne marked vascular early warning system (VEWS) device to detect peripheral arterial disease in patients with incompressible ankle arteries and non-measurable ankle brachial pressure index (ABPI) secondary to diabetes.
Methods: Recruited patients had diabetes, recent magnetic resonance angiography evidence of peripheral arterial disease (PAD), and incompressible vessels on ABPI. VEWS indices of each leg were automatically calculated by using optical infrared and red sensors applied to the foot, with readings obtained with the subject's leg both flat and elevated. Indices <1.03 and ≤0.94 were considered upper and lower diagnostic cutoff limits for PAD. Bollinger scores were calculated from the magnetic resonance angiography. A Best Bollinger Score (BBS) of <4 was defined as no significant PAD.
Results: All patients had tissue loss. Per protocol analysis of 28 limbs in 14 patients: VEWS had a sensitivity of 94% and specificity 20% for the detection of PAD at <1.03 cutoff and sensitivity 89% and specificity 80% at ≤0.94 cutoff. There was a good correlation between the VEWS index and BBS (-0.637; P = 0.0003).
Conclusion: VEWS is a safe, simple-to-use, promising tool to assist in the diagnosis of PAD in patients with incompressible vessels due to diabetes.
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