The research behind the technology

A recent study demonstrated an 86% reduction in diabetic foot ulcer recurrence when the Orpyx SI technology* was worn 4.5+ hours per day¹

This research reports when patients with diabetes and a previous history of a healed foot ulcer receive high pressure audiovisual alerts through a sensory insole system; there is a significant reduction in diabetic foot ulcer incidence.

The randomized, controlled, multi-site trial, conducted at Manchester Metropolitan University and Lancashire Teaching Hospital in the UK, used Orpyx SI technology which provided patients with real-time feedback, enabling them to take immediate action when sustained high pressure was detected. High pressure can cause skin damage on the soles of the feet, which if left untreated could lead to foot ulcers, infections and, in the worst case scenario, amputations.

The Orpyx SI technology continuously measured levels of pressure on the bottom of the feet. The patient received an audiovisual alert through a dedicated smartwatch when there was a dangerous amount of sustained high pressure. This instant feedback included the location of the high pressure point and prompts allowing the wearer to take immediate action to relieve the pressure on the affected area of the foot.

*Study was conducted with first generation SurroSense Rx^® which has the same pressure algorithm as Orpyx SI Sensory Insoles

58 people with diabetes, who had a high-risk of developing foot ulcers, participated in this 18 month study while going about their daily lives. Around half of the people received pressure alerts from the device (n=18), while the other half did not (n=22). The results of the study published in The Lancet Digital Health journal showed that the group receiving the pressure alerts were 71% less likely to develop recurrent foot ulcers compared to the group who didn’t receive the instant feedback. A subgroup of patients that wore the sensory insoles greater than 4.5 hours a day were 86% less likely to re-ulcerate.

“These results are meaningful as they reflect what is actually occurring on the plantar surface of the foot as the patients go about their daily activities,” stated Neil Reeves, PhD, study lead and Professor of Musculoskeletal Biomechanics at Manchester Metropolitan University in Manchester, UK. “Even more importantly, we know education alone is not sufficient to change the behaviour of patients with diabetic peripheral neuropathy (DPN). With this system, the patient can react to the alerts and immediately change their behaviour to relieve high pressures when they occur.”

Innovative plantar sensory insoles to prevent foot ulcer recurrence and guide treatment plans in patients with diabetic peripheral neuropathy³

This 17-patient case series examines the use of Orpyx SI^® Custom sensory insoles in patients at risk of DFU formation. Patients were remotely monitored by a nurse for plantar pressure, temperature, step-count, and hours of use, and were provided with real-time cues for pressure offloading as they went about their daily lives. The data collected from the sensory insole system was used to track activity, ulceration, and response to feedback from real-time alerts. Patients were contacted when areas of concern were seen based on collected data. The patients were provided with coaching and education related to reducing risk factors and overall support to improve foot health.

Of the 17 patients provided with the sensory insole system, 1 withdrew (no data collected) and 1 presented with a DFU. On average, patients used the sensory insole system for 4.7 hours per day, and increased usage over time. The patient who presented with a DFU had below average adherence (2.2 hours per day) prior to DFU development. Patients indicated that wearing the insoles with the real-time alerts increased their awareness of activities that due to their peripheral neuropathy, put them at risk for development of a wound. They also experienced more open communication with their providers. This system offers early intervention for at-risk patients, preventing more serious complications from occurring. Providers received information that they have never had before, allowing them to proactively bring patients into the clinic or office before a wound develops.