Of the more than 37 million Americans with diabetes, approximately half suffer from diabetic neuropathy. These patients are at heightened risk for serious foot injuries that could ultimately cost them their limb.
“They wear a hole in their feet just like you or I would wear a hole in our sock,” says David G. Armstrong, DPM, PhD, a podiatric surgeon at Keck Medicine of USC. “They kind of dissociate themselves from the body part because they’ve lost that ‘gift’ of pain” that would tell them to take it easy.
Armstrong and his team are studying a potential solution: an interactive smart boot designed to help diabetic patients recover from dangerous foot wounds.
The smart boot tracks the amount of time patients spend wearing it. Cloud-based technology shares data directly with the care team.
“The big idea is to eliminate preventable amputations over the next generation,” Armstrong says.
A study published in March in the journal Sensors found that using the remote patient monitoring solution may help promote adherence among older adults to wear offloading boots prescribed for diabetic foot ulcers.
Co-authored by Armstrong, it is the second study on the topic he has published on the therapeutic potential of smart boots for this patient population.
Consumer wearables as a solution for diabetic neuropathy
Relieving the pressure from the bottom of the foot is the key to healing a serious wound, Armstrong says. But while the gold standard is to put a cast on the foot, few doctors do this, he says, instead preferring to have patients wear a removable plastic boot.
The problem? “We’ve found that only about 28% of total activity is spent with those boots on” because the wounds cause no discomfort, says Armstrong.
“They’re walking around with a wide-open wound, destroying the bottom of their foot and putting themselves at greater risk for amputation.”
Now, in an ongoing study funded by the National Institutes of Health, Armstrong and other researchers are tracking the progress of dozens of patients with limb-threatening wounds wearing the smart boot. The team aims to enroll more than 200 people over a five-year period.
Armstrong and his team meet with patients weekly while the wound is healing and review how often they kept the boot on their foot.
Participants also receive smartwatches “so we can ping them and say, ‘Hey, Mr. Jones, the device is sitting next to your chair and not protecting your foot,’” says Armstrong, who is also the director of USC’s Center to Stream Healthcare in Place.
Still, the wide adoption of consumer wearable technology is making many patients more comfortable using digital health aids. “We’re seeing the inexorable merger of consumer electronics and medical devices,” Armstrong says.
Preventing future wounds
Armstrong doesn’t want to simply heal a patient’s wound and send them on their way. He wants to help prevent patients from suffering similar injuries in the future. “Our goal is to extend the number of days they don't have a wound recurrence, which can be really common,” he says.
Wearing the smart boot puts patients in the habit of protecting their feet and making it a part of their wellness routine.
“The smart boot can, first of all, keep people more adherent to protecting an open wound,” Armstrong says, adding that he and other providers also prescribe activities to patients during recovery such as checking the skin temperature on their feet.
“There is a lot of data to support that a wound will heat up before it breaks down, so you can detect it before the wound opens up,” Armstrong says. This data can help patients make decisions about how much pressure to put on their feet.
Providers can refer patients to the study at https://gracifinco.my.canva.site/boot-study-website or by emailing study manager Jason Garcia at Jason.Garcia@med.usc.edu