<title>Results of a 95-subject human clinical trial for the diagnosis of peripheral vascular disease using a near-infrared frequency domain hemoglobin spectrometer</title>

Abstract

A clinical trial has been performed on 95 human subjects to determine if Near Infrared (NIR) Frequency Domain Tissue Spectroscopy can detect and diagnose Peripheral Vascular Disease (PVD). Tests were performed using the ISS Oximeter on control subjects, patients at risk for PVD, patients with Intermittent Claudication, patients with Ischemic Rest Pain, and patients before and after hemodialysis. The tests consisted of measurements of total hemoglobin concentration (THC) and tissue oxygen saturation (StO2) before, during, and after walking on a treadmill. Ankle Brachial Index (ABI) measurements, a commonly used technique for PVD assessment, were also performed. Conclusions include; 1) NIR Oximetry does detect PVD, with baseline values, exercise induced values, and recovery rate measurements statistically different between the groups, 2) NIR Oximetry is more sensitive than ABI at detection of PVD in patients at risk, 3) NIR Oximetry detects dialysis induced drops in baseline oxygen saturation, as well as increases in baseline THC, 4) Reduced scattering coefficient t' has a widely variable baseline value in the patient population and does not remain constant during exercise, 5)In addition to the ability to assess PVD, the technique has other diagnostic capabilities.