Abstract

In this prospective, randomised, proof-of-concept study, patients with diabetes, and with peripheral neuropathy and a recent history of plantar foot ulceration were recruited from two multidisciplinary outpatient diabetic foot clinics in the UK, and were randomly assigned to either intervention or control. An insole system that continuously measured plantar pressure throughout the day was given to each patient. When abnormal pressures were found, the intervention group was given audiovisual notifications through a smartwatch connected to the insole system and offloading instructions, while the control group did not. Plantar foot ulcer development within 18 months was the main result. The ISRCTN number for this trial is ISRCTN05585501, and it is finished and closed to enrollment.