Path Active™ comprises a pair of monitoring insoles which measure parameters associated with foot ulceration in diabetes: temperature and pressure. The insoles are linked via an app to the wearer's mobile phone and also to a clinical dashboard so that both wearer and clinician are alerted to early signs of skin damage on the foot so that immediate preventive action can be taken. The study is a multisite randomised controlled trial which will evaluate the effectiveness of Path Active™ in 60 people with diabetes who are at 'high risk' of foot ulceration, compared with 60 people who receive their usual podiatry foot checks over a period of 12 weeks.
• Participant able to give informed consent.
Age >18 at the time of consent.
Diagnosis of Type 1 or Type 2 Diabetes.
Both Feet Intact (no ulceration).
Either foot has less than 2 arterial vessel run-off on Doppler.
Poor visual acuity ie registered blind, unless supported by carer.
Current participation in another clinical investigation of a medical device or a drug; or participation in such a study within 30 days prior to study enrolment.
Body Mass Index (BMI) >40.
Royal Free Hospital NHS Foundation Trust
Lead sponsor
Walk With Path
Collaborator