VisionQuest Biomedical Inc — Department of Health and Human Services SBIR Phase II: 200

Description

Summary The objective of this project is to validate the i RxTherm VisionQuest s patented functional thermal imaging system that produces biomarkers for early detection of diabetic peripheral neuropathy DPN This device is based on the principle that changes in microvascular function are correlated to quantifiable changes in nerve function as expressed in measureable microvascular changes 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 will develop a foot ulcer as a result of peripheral neuropathy during their lifetime Foot ulcers are the main cause of lower extremity amputation in patients with diabetes In Phase I of this project VisionQuest developed and tested the i RxTherm Phase I results demonstrated that the i RxTherm produced biomarkers to detects early signs of DPN Our results showed that the i RxTherm can differentiate between normal controls and patients with DPN with high sensitivity and specificity Furthermore we demonstrated that the i RxTherm identified diabetics who were undiagnosed with DPN but who were later confirmed to show early to moderate signs of DPN In Phase II of this project our objective is to validate these results in a larger cohort of subjects and to develop a low cost clinical prototype that can be used in the primary care setting There are three specific aims to be accomplished in this grant application The first aim is to identify and quantify specific biomarkers of levels of severity or stages of DPN To achieve this aim we will collect data from subjects that will include normal controls and patients diagnosed with DPN The second aim is to collect data from diabetics with previously undiagnosed DPN and to demonstrate that our classification methodologies identify patients with diabetes who present with early to moderate signs of DPN and who have not been previously diagnosed for the disease In the final aim we will develop and test a low cost version of the i RxTherm that can be used in the primary care setting At the end of this project we will have a fully validated device that will provide a more effective means of screening and early detection of DPN Narrative Peripheral neuropathy is a complication of diabetes that causes amputations in of diabetics with of them having lower extremity amputations a year In this project we will complete the development of the i RxTherm a thermal optical imaging system that can detect early signs of diabetic peripheral neuropathy thus solving the public health need for screening and early detection of this complication of diabetes