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

Recruiting now · Not applicable

Conditions studied: Diabetic Foot

In brief

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.

Key facts

Study ID

NCT06084052

Run by

Royal Free Hospital NHS Foundation Trust

People needed

120

Starts

2024-04-02

Expected to finish

2026-03-31

Last updated by the study team

2025-04-15

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• 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.

Where it is running

• Royal Free Hospital — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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