A Prospective, Multicenter clinical trial to validate the diagnostic accuracy of Nerve Vue in detecting Peripheral Arterial Disease (PAD)

The main purpose of this study is to evaluate whether Nerve Vue can accurately detect and monitor Peripheral Arterial Disease (PAD) in human subjects. Specifically, the study aims to determine if the device can identify early signs of compromised blood flow that are characteristic of PAD, thereby enabling proactive healthcare interventions and personalized care for at-risk individuals.

Background

Cardiovascular and metabolic health disorders remain major global health concerns, contributing to significant morbidity, mortality, and healthcare costs. Among these disorders, Peripheral Arterial Disease (PAD) is a particularly prevalent condition characterized by reduced blood flow to the limbs due to arterial narrowing or blockages. PAD often coexists with metabolic syndrome-an umbrella term encompassing risk factors such as obesity, insulin resistance, dyslipidaemia, and hypertension. When left unaddressed, PAD can lead to serious complications such as pain, limited mobility, and increased risk of cardiovascular events. Despite its prevalence, early detection of PAD remains challenging. Conventional diagnostic methods (e.g. Ankle-Brachial Index, Doppler ultrasound) are effective but can be time-intensive or require specialized equipment and expertise. This often results in underdiagnosis of PAD- especially among individuals with subclinical or mild disease. Consequently, there is a need for non-invasive, user-friendly technologies that enable earlier identification and monitoring of vascular compromise in diverse healthcare settings. In line with this need, the investigational device Nerve Vue integrates photoplethysmography (PPG) and piezoelectric sensors to capture and analyse peripheral pulse signals. By providing a rapid and comprehensive assessment of blood flow, Nerve Vue may allow healthcare professionals to identify early vascular changes indicative of PAD. This could ultimately facilitate proactive management strategies, mitigate progression, and improve overall vascular outcomes in affected individuals.