A Wearable Insole System to Measure Plantar Pressure and Shear for People with Diabetes

Pressure coupled with shear stresses are the critical external factors for diabetic foot ulceration assessment and prevention. To date, a wearable system capable of measuring in-shoe multi-directional stresses for out-of-lab analysis has been elusive. The lack of an insole system capable of measuring plantar pressure and shear hinders the development of an effective foot ulcer prevention solution that could be potentially used in a daily living environment. This study reports the development of a first-of-its-kind sensorised insole system and its evaluation in laboratory settings and on human participants, indicating its potential as a wearable technology to be used in real-world applications. Laboratory evaluation revealed that the linearity error and accuracy error of the sensorised insole system were up to 3% and 5%, respectively. When evaluated on a healthy participant, change in footwear resulted in approximately 20%, 75% and 82% change in pressure, medial-lateral and anterior-posterior shear stress, respectively. When evaluated on diabetic participants, no notable difference in peak plantar pressure, as a result of wearing the sensorised insole, was measured. The preliminary results showed that the performance of the sensorised insole system is comparable to previously reported research devices. The system has adequate sensitivity to assist footwear assessment relevant to foot ulcer prevention and is safe to use for people with diabetes. The reported insole system presents the potential to help assess diabetic foot ulceration risk in a daily living environment underpinned by wearable pressure and shear sensing technologies.

Automated summary

Pressure and shear stresses are critical for diabetic foot ulceration assessment and prevention. However, a wearable system capable of measuring in-shoe multi-directional stresses for out-of-lab analysis is currently lacking. This study reports the development of a sensorised insole system, which showed potential for real-world applications in evaluating foot ulceration risk. The system demonstrated comparable performance to previous research devices and is safe for use by people with diabetes.