Clinical Trial

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

Study acronym: PAMRCT
Recruiting
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Record status
This record was last updated April 15, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-10-11; most recent amendment 2025-04-11.
Status change: Completed → Recruiting 2024-07-05
Status change: Recruiting → Completed 2024-04-09
Trial Details
NCT Number NCT06084052
Lead Sponsor Royal Free Hospital NHS Foundation Trust
Collaborators: Walk With Path
Conditions Diabetic Foot
Enrollment 120 participants
Start Date 2024-04-02
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-15