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.
Single group
Path Active
DeviceParticipant use of Path Active insoles, mobile phone app and clinician's dashboard (where pressure and temperature changes can be reviewed by a clinician). All participants will complete a patient questionnaire relating to use of the device and EuroQol - EQ5D at the beginning and end of the study.
Control Group
Other interventionControl Group will receive care as usual.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The primary objective of this clinical investigation is to evaluate the effectiveness of Path Active™ in people with diabetes who are at 'high risk' of foot ulceration.
Changes Quality of Life Measurement
EuroQol EQ-5D-5L assessment for quality of life assessment at the beginning and end of the study period. The EQ-5D-5L health profile includes the items mobility (MO), self-care (SC), usual activities (UA), pain/discomfort (PD) and anxiety/depression (AD). The EQ-5D-5L asks respondents to endorse one of five response levels for each item: "no problems," "slight problems," "moderate problems," "severe problems," and "extreme problems"/ "unable to", describing 3125 (55) health state profiles. The instrument also includes a visual analog scale (VAS) anchored by 0 (worst imaginable health) and 100 (best imaginable health) that will be analysed separately from the health profile.
Device questionnaire
Participants in the 'Path Active' arm will complete study questionnaires relating to the product (ease of use, use of the mobile phone app, use of the insoles, action taken relating to app warnings).
Control Group questionnaire
Participants in the 'Control Group' arm will complete study questionnaires relating to their usual care (how often do you see a healthcare professional for foot checks, how often do you examine your feet, how concerned are you about developing a foot ulcer etc)
Reduction in CO2 comparing carbon dioxide emitted due to ulcer treatment vs carbon dioxide emitted due to device manufacture
To model the carbon dioxide reduction that occurs if ulceration and the need for ulcer treatment is prevented, in differing UK geographies. The carbon footprint for the manufacture and life span of the device will been calculated and the carbon footprint for ulcer treatment will be calculated. The difference between CO2 due to manufacture of the device will be compared with the CO2 required for ulcer treatment to show how much reduction in carbon can be made by preventing foot ulceration when using Path Active.
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Royal Free Hospital NHS Foundation Trust
Lead sponsor
Walk With Path
Collaborator
