RECRUITINGINTERVENTIONAL

Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - • Participant able to give willing to sign a consent form. - Age \>18 at the time of consent. - Diagnosis of Type 1 or Type 2 Diabetes. - Both Feet Intact (no ulceration). - Participant understands and is willing to participate and can comply with the follow-up regime. - Participant diabetes foot Risk Stratification as 'High Risk' as in Frame (2021) Scotland/England https://www.diabetesframe.org/ - Ability to walk independently for \> 100 metres i.e without use of wheelchair, walking stick or personal assistance. - Participant able and willing to wear suitable footwear. - Must own a mobile phone and be willing to upload WWP app. Who Should NOT Join This Trial: - 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. - Participant has bespoke contact insoles and footwear. - Participant is unable to use 'medium' or 'large' insoles due to foot size eg. small or extra large feet. - Participant has a pacemaker. - Participant is pregnant. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * • 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). * Participant understands and is willing to participate and can comply with the follow-up regime. * Participant diabetes foot Risk Stratification as 'High Risk' as in Frame (2021) Scotland/England https://www.diabetesframe.org/ * Ability to walk independently for \> 100 metres i.e without use of wheelchair, walking stick or personal assistance. * Participant able and willing to wear suitable footwear. * Must own a mobile phone and be willing to upload WWP app. Exclusion Criteria: * 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. * Participant has bespoke contact insoles and footwear. * Participant is unable to use 'medium' or 'large' insoles due to foot size eg. small or extra large feet. * Participant has a pacemaker. * Participant is pregnant.

Treatments Being Tested

DEVICE

Path Active

Participant 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.

OTHER

Control Group

Control Group will receive care as usual.

Locations (1)

Royal Free Hospital

London, United Kingdom