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

NCT06084052 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-04-15

No results posted yet for this 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.

Conditions

  • Diabetic Foot

Interventions

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.

Sponsors & Collaborators

  • Walk With Path

    collaborator INDUSTRY

  • Royal Free Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Richard Leigh, BSc · Royal Free London NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06084052 on ClinicalTrials.gov