Plantar Sensory Insoles for DFU Prevention: Case Insights

What were the parameters of your recent case series that used plantar sensory insoles for diabetic foot ulcer prevention in patients with neuropathy?

We actually started out with a 40 patient trial, organizing around just basically, it's the first trial that they've run since the they remodeled the insole, so we wanted to see where we could go on, catching ulcers, people who had already had ulcers and preventing recurrences. And so, the evolution of the tech the space was we just grabbed 40 patients, put them in the device. Now, I know this is a smaller subset, and then we did a subset of the people that had breakdown, where we caught them and how we move forward. And then the next step of the product was actually modifying the devices and seeing that actual major offloading adjustments help prevent or the recurrence of the officers as well. 

What findings did you note in your series?

So what we were able to show is that by bringing in, the device, we're able to capture and prevent or ulcers, earlier. We're able to if we the patient did develop a small area, we're able to bring them into the clinic sooner through the remote patient monitoring pathway and able to resolve the ulcer much quickly or prevent it from progressing at all to a full ulcer. We're able to show that the use of the insoles, increased as the patients more than went further through the trial. So, in the early phases, we're typically seeing about 2 to 4 hours said they and by the end of the hour, we're seeing 6 to 8 hours of use for the device a day, which obviously, the more use of the device, the better chance of catching ulcers along the way. 

Patient selection is very critical, but patients who, are engaged in their wound care and don't want to have a new ulcer or don't want to have their first ulcer, this technology is definitely critical for the profession the the prevention of ulcers for patients.