NCT06084052 Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)
| NCT ID | NCT06084052 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Free Hospital NHS Foundation Trust |
| Condition | Diabetic Foot |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-04-02 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Richard Leigh, BSc
STUDY CHAIR
Royal Free London NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT06084052 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Diabetic Foot. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06084052 currently recruiting?
Yes, NCT06084052 is actively recruiting participants. Contact the research team at richardleigh1@nhs.net for enrollment information.
Where is the NCT06084052 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06084052 clinical trial?
NCT06084052 is sponsored by Royal Free Hospital NHS Foundation Trust. The principal investigator is Richard Leigh, BSc at Royal Free London NHS Foundation Trust. The trial plans to enroll 120 participants.