Benefits of insoles with real-time alert and foot self-care education in improving offloading and adherence to prescribed footwear in patients with diabetes mellitus: Study protocol for a single-blinded randomized clinical trial PREPRINT (Version 1)

Unprotected plantar pressure contributes to the development of diabetic foot ulcers (DFU) in people with diabetes and loss of plantar sensation. Recently, smart footwear device is proposed to empower patients at risk in avoiding harmful weight-bearing physical activities such as prolonged standing which may lead to local plantar ischemia and ultimately a DFU. However, there is little progress in the education of at-risk to be engaged in daily using of these smart footwear devices as well as adherence to diabetic footwear. The aim of this study is to examine whether an integration of smart insoles with an alert (smart watch) and foot self-care education may sustain adherence to prescribed footwear and change patients’ behavior to avoid harmful physical activities such as prolonged standing posture.