VisionQuest Biomedical and the University of New Mexico School of Medicine have been awarded a three-year US$3 million grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH), to complete the clinical validation of a new technology to detect early signs of diabetic peripheral neuropathy (DPN), also known as diabetic foot.
Peter Soliz, founder and chief technology officer of VisionQuest, says, “Our patented technology for detecting early signs of peripheral neuropathy will fundamentally change how physicians manage this severe complication of diabetes. This system will complement our already successful EyeStar system for the detection of diabetic retinopathy and will allow us to screen for multiple diabetes complications in one visit.”
Mark Burge, deputy director of the University of New Mexico’s Clinical & Translational Science Center (CTSC) and co-principal investigator on this project, adds, “A simple test that can be performed by the primary care physician in the clinic and which is highly sensitive and specific does not currently exist. This device will fill an important gap in providing comprehensive care to individuals diagnosed with diabetes.”
Diabetes affects 34.2 million people in the USA, or 10.5 percent of the population. The Foundation for Peripheral Neuropathy estimates that over 70% of people diagnosed with diabetes have developed DPN, a painful complication of diabetes that leads to loss of sensation, foot ulcers, and nearly 54,000 amputations per year.
Current screening methods cannot reliably detect the early stages of DPN, when preventative care can improve outcomes. VisionQuest’s fully automated, noninvasive system analyses real-time thermal video of changing temperatures on the bottom of the foot to produce highly sensitive and consistent measurements of blood flow that can be used for diagnosis in primary-care clinics and do not require interpretation. The device and technique were awarded a US patent in 2014.
Through this NIDDK grant, VisionQuest will complete the clinical validation needed to pursue clearance by the US Food and Drug Administration (FDA) to bring the device to market in the USA.