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

Abstract 

Introduction
About 25% of diabetics will develop a diabetic foot ulcer (DFU) in their lifetime. 49% of DFU patients experience recurrence within 1 year (68% experience recurrence within 5 years). High plantar pressure is a major risk factor in the DFU development, and recent evidence shows that continuous plantar pressure monitoring and dynamic offloading guidance can lead to reduced DFU recurrence.

This case series examines the use of sensory insoles in patients at risk of DFU. This sensory technology is the first to ever collect plantar data on pressure, temperature, step-count, and adherence to inform treatment decisions to reduce DFU risk.

Methods
17 patients were provided with custom-made sensory insoles to monitor plantar pressure, temperature, step-count, and adherence, and provided with real-time cues for pressure offloading as they went about their daily life. The sensory insoles were used to track compliance, ulceration, and response to feedback from real-time alerts. Patients were monitored remotely by a qualified healthcare professional and contacted when areas of concern were seen and provided coaching on reducing risk factors and overall support to improve foot health. As this case series is part of a larger, ongoing study, patients are continuing to be enrolled and outfitted with the insoles.

Results
Of the 17 patients provided with the insoles, 1 withdrew (no data collected) and 1 presented with a DFU. Patients indicated wearing the insoles with real-time alerts increased awareness to activities that, due to their peripheral neuropathy, put them at risk for development of a wound.

From the clinician’s side, the patient’s increased awareness allowed for open communication between patient and provider. The sensory insoles provided the patient with contextualized information to guide foot health conversations and treatment in clinic. Patient data was captured for review by the clinician informing insight to potential areas of concern on the plantar foot.

Discussion
This case series explores the use of a novel technology to collect newly available plantar data (pressure, temperature, step-count, and adherence) for DFU detection and prevention. The results from this case series suggest that feedback generated by sensory technology is effective in helping to reduce the incidence of DFUs in patients with diabetic peripheral neuropathy. The data collected from sensory technology can be used to inform and guide treatment decisions in clinic. The results also suggest the importance of Remote Patient Monitoring in helping to reduce diabetic foot ulcer occurrence and provide early intervention for lesions that may develop.