Diabetic peripheral neuropathy (DPN) is a common, worldwide complication of diabetes mellitus (DM). According to the CDC statistics for year 2017, 30.2 million Americans were reported to have diabetes with 1.4 million new diabetic cases diagnosed every year. At least 50% of patients with diabetes will develop DPN sometime in their lives, and up to 20% have DPN at the time of diabetes diagnosis. DPN can result in foot or limb amputations in 15% of diabetics, with 82,000 lower extremity amputations occurring in the US annually. Therefore, an accurate means to detect the presence of early-stage DPN is critically needed to improve outcomes when intervention is most effective. VisionQuest Biomedical has assembled a team of collaborators representing an inter-disciplinary group of scientists with considerable experience in automated thermal image analysis, diabetes comorbidity diagnosis and treatment, and specialized research in DPN and podiatry. This team will continue to develop and test i-RxTherm ?, our patented device based on the principle that skin blood flow is regulated by several neuronal factors that are affected by diabetes, which in turn, alter the thermoregulation process in DPN patients. This approach enables the detection of the effect of small or large fiber neuropathy. i-RxTherm integrates a thermal imaging camera and a fully automated thermal image analysis software, that will increase the diagnostic accuracy for DPN, leading to a smaller number of DPN patients that are otherwise missed by the currently available clinical tools. The core innovation of i-RxTherm is its ability to detect any type of DPN, namely small and large fiber DPN, a capability that no other single device currently has and one that will allow it to become the standard of care for DPN screening among physicians. In Phase II, we developed image analysis software to detect DPN using thermal videos of plantar foot that demonstrated excellent performance with sensitivity of 85% and specificity of 75%. Driven by the Phase II success, the main objective of Phase IIB is to put the devise on a commercial path through a productization process that will make it ready for widespread use in screening. At the end of this project, i-RxTherm will be at a commercial readiness stage where interest from third party investors is maximized. We will accomplish these goals through the following specific aims: 1) Design and build a portable device suitable for FDA testing and validate its intended use. iRxTherm will be tested non-interventionally at our collaborator?s facility, the University of New Mexico?s Clinical & Translational Science Center; 2) Conduct a clinical study to validate the commercial iRxTherm. The clinical study will enroll a cohort of N =336 subjects diagnosed with diabetes. This sample size is determined based on a statistical power analysis to reject the null hypothesis of our primary end point (sensitivity/specificity of <85%/75%). By the end of Year 2 of the grant, the i-RxTherm will enter into a clinical trial at the start of Year 3 that meets all FDA requirements. Once cleared, our clinical collaborators will become the early adopters of i-RxTherm where it will become the standard for DPN screening.
Diabetic peripheral neuropathy (DPN) is a complication of diabetes that results in amputations in 15% of diabetics. The screening of early stage DPN can lead to timely intervention and better long-term outcomes. In this project, we will validate the i-RxTherm ? in a clinical environment to demonstrate that it is ready for the FDA clinical trial, which will begin immediately at the start of Year 3 of the grant. A strategic business plan will be implemented in Year 1, based on the definition of the market and validation of a revenue stream. The marketing and the clinical trial will be funded by private investors. We will show that i-RxTherm can detect early signs of DPN, thus solving the public health need for early detection and diagnosis of this complication of diabetes.