Six and a half million Americans suffer with chronic wounds each year, with $25 billion spent annually to treat them. That number is expected to rise, as chronic wound risk increases with age. One in five Americans will be over 65 years old by the year 2030. Also contributing to a projected rise is growing numbers of diabetes and obesity patients—conditions which often coincide with chronic wounds. Despite the rapid evolution of innovation and technology in medicine, the standard practice to determine the size of these wounds – and decide on costly treatment plans aimed at healing them — for millions of patients is a ruler.
“Believe it or not, the way we see if a treatment is working is we take a ruler and measure the length and width of the wound and then estimate the depth,” said Michael Weingarten, MD, MBA, FACS, a professor and assistant dean in Drexel’s College of Medicine. “But this can be very inaccurate. I can measure a wound, my nurse can measure the same wound and get a different reading. The following week, we might not measure the exact same spot. You’re basing costly treatment options on whether the wound is healing, but you’re not getting an accurate measure to guide decisions.”
Seeing how ripe this area was for new discoveries, 15 years ago, Weingarten, a vascular surgeon with 30 years of treating patients suffering from chronic non-healing wounds, met with colleagues in the College of Medicine and School of Biomedical Engineering, Science and Health Systems to brainstorm areas for collaboration. Weingarten says chronic wounds — those that do not heal within eight weeks – are almost always associated with conditions like diabetes.
“Essentially there were a bunch of geniuses sitting on the west campus, who were making these amazing devices and doing great research and we had a lot of patients who needed a lot of help,” said Weingarten. “Our biomed colleagues were studying near infrared imaging and we knew early there was potential to apply this to health care.”
Among the team’s advances in this field is a 2012 paper in the Journal of Wound Repair and Regeneration, in whichWeingarten and colleagues found that using non-invasive, diffuse near-infrared spectroscopy, allowed them to predict the effectiveness of a wound-healing treatment in four weeks (better than the length, width and depth method) and to eliminate treatments that weren’t working. The findings showed that stopping the treatments that didn’t work after four weeks could have saved $12,600 per patient. It also improved wound care before it turned to limb loss.
“If you see that you’re applying various topical agents to the wound and using other technologies such as hyperbaric oxygen and they are not working, you can change the path of treatment, which may get the wound to heal and ultimately save the patient’s leg,” said Weingarten.
Now Weingarten and colleagues have developed a patented device, licensed to Emunamedica LLC, that uses infrared technology to measure would healing. The team hopes the device will be used by doctors and nurses not only in hospital settings, but also nursing facilities, and by homecare nurses who would get the data and share it with a clinician who would interpret it and advise on the best treatment path. The device recently moved a step in that direction, obtaining “Breakthrough Device” designation from the United States Food and Drug Administration (FDA), the company reports.
“We’ve learned from years of research that the data shows potential for non-invasive infrared technology as the future of detecting whether a wound will heal using a particular treatment option,” said Michael Neidrauer, PhD, a part-time research assistant professor in the School of Biomedical Engineering, Science and Health Systems, who was working toward his PhD at Drexel when he began working on this technology, more than 10 years ago. “Harnessing this technology effectively may potentially save millions of dollars in health care costs, but more importantly, vastly improve the quality of life for these patients.”
The FDA’s Breakthrough Devices program gives companies additional access to FDA officials and expertise to more efficiently and effectively evaluate issues or challenges in the premarket review phase and give “prioritized review” of the device submission.