New Zealand based company Zephyr Technology is working with scientists at AUT University in Auckland to create high tech insoles for shoes, using sensor technology to measure foot temperatures to sense the onset of potential ulceration conditions in diabetics, potentially reducing a major health problem that results in 90,000 amputations each year in the United States.
The ShoePod Diabetic is a thin Smart Fabric shoe insole which measures temperatures, coupled with a wireless data transmitter and recorder. Graphical diagnostic tools enable accurate comparative analysis, providing early warning of foot ulceration due to DPN (Diabetic peripheral neuropathy) using Bluetooth-type protocol that would allow communication to a Mobile or other such device. It is the first diagnostic product able to be used without restricting the wearer's everyday activity.
Zephyr Technology Director for Business Development, Steven Small told IDTechEx, that diabetics can develop a condition called DPN which is when the nerves are damaged. As DPN causes lost feeling in the extremities, the afflicted cannot detect the onset of ulceration. ShoePod Diabetic will provide early warning of the conditions leading to ulceration and potential amputation by sensing both plantar pressures and temperature "hot spots."
By providing continuous monitoring, ShoePod acts as a replacement for the damaged nerve endings of the diabetic patient. Upon detection of conditions potentially leading to ulceration, ShoePod alerts the wearer through audible and/ or visible signals. These alerts encourage the patient to take action that would prevent further damage.
"We are developing a product that could alert the patient before the ulceration occurs by using real time temperature sensors, not currently available."
Small also said, "The Inner sole for the shoes is at prototype stage with trials scheduled for the end of October. Some challenges need working through to get through the FDA approval process but because this is just an early warning device which has a classification 1, approval should take less than 6 months."
Chris Hardaker, the Product Manager heading up the commercial effort to get the product to market at Zephyr said "I don't see any significant hurdles other than the paper trail to finalise the process."
"The sensor is currently mounted on a flexible PCB as we couldn't find anybody that could offer printed temperature sensors that could deliver life expectancy needed at the comfort level and accuracy required. We are still looking as final design stage is about 3 months away," added Hardaker.
Up to 70 percent of all non-traumatic lower extremity amputations (LEAs) in the U.S. each year are from complications due to diabetes. Furthermore, approximately 85 percent of the 90,000 diabetes-related LEAs per year in the U.S. could be prevented with early detection.
Diabetes presents a serious financial burden for the healthcare system, as the disease carries direct costs of $92 billion dollars per year in the U.S., according to the Centers for Disease Control and Prevention. Foot conditions due to DPN have direct costs of approximately $11 billion, which does not include lost work hours, decreased productivity, and deterioration of the quality of life for the amputee.
An acknowledged world authority on the diabetic foot, Dr David Armstrong, Professor of Surgery, Chair of Research and Assistant Dean of the Dr. William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science in Chicago and his colleagues are working with Zephyr to develop and promote the technology. They will also be actively involved in the trials being held in the US later this year.