A US National Institutes of Health (NIH)-funded randomised controlled trial is due to commence this month to assess the efficacy of continuous digital monitoring in reducing diabetic foot ulcer recurrence among high-risk patients.
Led by Caitlin Hicks and colleagues at the Johns Hopkins University School of Medicine (Baltimore, USA), the WIREDUP study aims to enrol 400 patients with a diabetic foot ulcer that has healed within the past 12 months.
In the trial, this high-risk group of patients will be randomised to receive either a diabetic shoe with a custom insole—the current standard of care—or a diabetic shoe with a custom insole that features pressure and temperature sensor technology connected to a patient-facing application.
In this latter group, Hicks explains, “the patients have an app on their phone, which will send them alerts if they’re having excessive onloading, meaning too much pressure in one area of the foot for sustained periods of time”. This information will then be sent through an escalation pathway to promptly resolve the issue.
The primary outcome of the study is time to ulcer recurrence, with Hicks hypothesising that the digital monitoring technology “should be able to delay or reduce ulcer recurrence” in high-risk patients and catch reulceration earlier when it does occur. The team also plans to collect patient-reported health and digital technology utilisation outcomes, as well as cost-effectiveness data.
At the centre of the trial are the sensory insoles and digital health platform set to be used in the intervention arm, both of which have been provided by Canada-based company Orpyx Medical Technologies.
“The tech is widely accepted in Canada, but Orpyx needs a clinical efficacy trial to get into the US market”, Hicks says, underlining the rationale behind the WIREDUP trial.
The technology in question has existed for over a decade and has been through several iterations, with Hicks describing the current version as “very slick”. “The insoles don’t have to be plugged in, they all have insole batteries”, she says.
Hicks specifies that the trial will involve nurses employed by Orpyx to review the data from the platform—including insole wear patterns, adherence, and temperature and pressure patterns—on a weekly basis and “reach out to the patient to help them troubleshoot if things aren’t going as planned”.
The trial is set to begin recruitment this month after having received NIH funding in September last year. “We’d been waiting on funding for a while”, Hicks shares, citing delays arising from the US government shutdown in the early stages of the process. “We have been in a feasibility run-in phase for a while, where we are trying to identify patients and keep track of people who might be interested in participating in this.”
Alongside her team at Johns Hopkins and the Orpyx collaboration, Hicks also acknowledges the involvement of researchers at the University of Southern California (USC; Los Angeles, USA). “It’s a bi-costal trial”, she says, noting that several other sites are also set to join the project. Furthermore, Hicks underlines the multidisciplinary nature of the trial, with podiatrist David Armstrong heading up recruitment at USC.
Considering the wider context of the trial, Hicks comments that digital health technology in the diabetes space is in an “exciting” phase, while acknowledging a somewhat crowded market. “There are a lot of different products out there, and I think what’s important now is to try and weed through what’s available to find options that are really going to help patients in a meaningful way.”
Breanne Everett, chief executive officer (CEO) and president of Orpyx, adds: “The WIREDUP trial is an important step toward understanding how continuous foot monitoring can help prevent wounds, reduce amputation risk, and support mobility for people living with diabetes. We’re proud to support this investigator-led, NIH-funded study and to contribute technology focused on improving real-world outcomes.”
