Spectral MD Initiates Multi-Center Clinical Study for Diabetic Foot Ulcer
17 December 2020
Spectral MD's DeepView Wound Imaging System will collect critical data to further develop its multi-spectral imaging and artificial intelligence-based wound-healing prediction technology
Spectral MD announced today the start of an IRB-approved multi-center study to support the development of its Diabetic Foot Ulcer (DFU) application for the DeepView Wound Imaging System. The patented DeepView Wound Imaging System combines multi-spectral imaging and Artificial Intelligence (AI) to provide clinicians with an immediate healing assessment for DFU, which enables clinicians to provide a more accurate and timely diagnosis for therapeutic intervention. Building upon promising results from a 2019 proof-of-concept study, Spectral MD will bolster its existing clinical database of DFU images and physiologic information to train and improve the diagnostic accuracy of the DeepView AI algorithm.
Dr. Terry Treadwell, a past-president of the Association for the Advancement of Wound Care and Medical Director for the Institute of Advanced Wound Care at Baptist Medical Center in Montgomery, Alabama, will serve as the Principal Investigator for the study. Dr. Treadwell stated, “DeepView is a non-invasive imaging technology using multiple spectral wavelengths to measure biomarkers in the wound bed and surrounding soft tissues. The device will enable us to detect problems potentially allowing much earlier more appropriate treatment of the wound. Follow-up studies with the device will let us know if our therapies are having the desired effect.”
Currently, insurance companies require physicians to assess and document a DFU for 30 days before advanced wound care therapies, such as hyperbaric oxygen, negative pressure wound therapy, and synthetic skin substitute grafts can be used. DeepView and its DFU algorithm are designed as a decision-assist diagnostic tool to provide meaningful clinical output which facilitates earlier stage appropriate therapies that could potentially accelerate healing times.
Dr. Jeffrey Carter, Chief Medical Consultant for Spectral MD stated, “Over 25 million Americans have diabetes mellitus and are at risk for DFU. Early referral to multidisciplinary diabetic foot clinics, like Dr. Treadwell’s, can decrease progression of the disease and facilitate prevention, intervention, and surveillance and much earlier stages. His understanding of DeepView’s potential to improve wound care will help ensure that the study is well executed.”
“For such a widespread diabetic complication and the leading cause of limb-loss in the US and Europe, it is surprising that there are no tools available to diagnose diabetic foot ulcers at much earlier stages that need more than standard techniques to heal,” said Dr. Jeffrey Thatcher, Chief Scientist for Spectral MD. “This study gives us the opportunity to work with leading wound care providers like Dr. Treadwell to develop an effective and useful early stage wound assessment device. We are eager to apply our expertise in optical imaging and AI to help guide treatment decisions that will potentially lead to increased healing rates for these patients and far lower lifetime treatment costs.”
About Spectral MD:
We are a dedicated team of forward-thinkers striving to revolutionize the management of wound care by “Seeing the Unknown” with our DeepView® Wound Imaging System.