VisionQuest Biomedical Inc — Department of Health and Human Services SBIR Phase I: NIDDK

Description

DESCRIPTION provided by applicant Diabetes affects an estimated million people worldwide including more than million Americans Diabetic patients are at risk for a wide array of complications including heart disease kidney disease nephropathy ocular diseases diabetic retinopathy and diabetic foot peripheral neuropathy Fifteen percent of diabetics wil develop a foot ulcer as a result of peripheral neuropathy during their lifetime Foot ulcers are th main cause of lower extremity amputation in patients with diabetes VisionQuest Biomedical LLC and the University of New Mexico UNM have formed a team to study a population of diabetics with and without diagnosed peripheral neuropathy in order to gain a better understanding of how a personandapos s auto thermo regulation after a cold provocation reflects neuronal changes in peripheral neuropathy The study will use standard clinical examinations such as monofilament sensory tests as well as less standard exam techniques such as sympathetic skin response to compare with dynamic infrared functional imaging The functional infrared imaging techniques have been developed and applied by our group as part of a pilot study A prototype functional thermal imaging device has been tested on a number of subjects that shows strong indications of its capacity to measure thermal regulation in the plantar foot and demonstrates potential as a biomarker for accurate quantification of DPN changes progression in type T D or type diabetes T D Our preliminary experimental data results produced highly compelling evidence that thermal functional technology can detect differences between normal controls and diabetics with or at risk for peripheral neuropathy There are three specific aims to be accomplished in this grant application The first aim is to establish a normative range for the functional response to thermal stimulus as measured by an infrared imaging device by studying control subjects In the second aim we will study the variation in the thermally derived functional signal in diabetics with diagnosed peripheral neuropathy The third aim is to apply the protocol developed in Aim to conduct a clinical study with diagnosed subjects with diabetes without peripheral neuropathy Features such as recovery time recovery pattern both temporal and spatial will be correlated with clinical diagnostic measurements such as nerve conduction velocity tests and ankle brachial index tests Clinical examinations will be performed by our collaborating podiatrist PUBLIC HEALTH RELEVANCE Peripheral neuropathy is a complication of diabetes that causes lower extremity amputations a year Fifteen percent of diabetics will undergo amputation some time in their lives In this project we will study the nature of thermal autoregulatory response in diabetics with and without peripheral neuropathy A thermal optical imaging system will be used to study the thermo regulation in the plantar foot after cold provocation This methodology has great promise as an inexpensive non invasive and most of all very sensitivity clinical exam for early detection of diabetic peripheral neuropathy