Smart Insoles: Assessing their Clinical Potential

Orpyx’s SurroSense Rx® was recently mentioned LER Magazine. Lower Extremity Review or LER Magazine fills the lower extremity information gap for practitioners in the fields of Podiatry, Physical Therapy, O&P Pedorthics, and Orthopaedics. The article discusses how athletes have been quick to embrace smart insoles and the biomechanical data generated by the devices’ embedded sensors. However, experts believe smart insoles may also have potential clinical applications for patients with foot health problems, such as diabetic neuropathy.

Surrosense Rx is a sensor-embedded insert that captures pressure data from feet. The data are sent wirelessly to a smart watch device (which is packaged with the insoles). According to the company, the “smart watch alerts you when dangerous time and pressure levels are detected, so you can modify behavior and avoid damage.”

The market for Surrosense Rx is patients with diabetes. Bijan Najafi, PhD, director of clinical research in the Division of Vascular Surgery and Endovascular Therapy at Baylor College of Medicine in Houston, and colleagues recently conducted a pilot study to test the recurrence of diabetic foot ulcers in patients using the device, which is considered a class I medical device and therefore is exempt from FDA 510(k) premarket review.

The study included 21 patients with diabetic neuropathy and recently healed ulcers. The participants received an average of 3.38 daily alerts per day, of which nearly 44% were successfully managed, Najafi said. In addition, the majority of the alerts (45.8%) were related to pressure changes under the metatarsal heads, which is one of the plantar surfaces that is most prone to ulceration.

Real-time feedback and a “user-friendly” interface are two factors that can make a smart insole stand out, said Najafi, who is also director of Interdisciplinary Consortium on Advanced Motion Performance (iCAMP) at the University of Arizona, where the pilot study was conducted. The study was partially funded by Orpyx.

“The big challenge is still how to visualize or feed back key information to patients for assisting them to take care of their own health,” Najafi said. “Another key challenge is how to engage patients to continue wearing these insoles.”

For Armstrong, a coauthor on the study, smart insoles like Surrosense Rx that rely on sensory substitution technology—or the use of one sensory modality to supply environmental information normally gathered by another sense while still preserving some of the key functions of the original sense—will have the longest staying power in the market.

“There are other kinds of insoles that measure pressure or temperature, but most of them haven’t reached the same level of sophistication as the sensory substitution devices,” he said.

Read the full article here.