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

Summary

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.

Eligibility

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.

Conditions2

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