Actively Recruiting
Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)
Led by Royal Free Hospital NHS Foundation Trust · Updated on 2025-04-15
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
R
Royal Free Hospital NHS Foundation Trust
Lead Sponsor
W
Walk With Path
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent
- Age over 18 years at the time of consent
- Diagnosed with Type 1 or Type 2 Diabetes
- Both feet intact with no ulceration
- Understands and is willing to participate and comply with follow-up
- Classified as 'High Risk' for diabetic foot ulceration according to Frame (2021) Scotland/England
- Can walk independently for more than 100 metres without assistance
- Able and willing to wear suitable footwear
- Owns a mobile phone and willing to upload the monitoring app
You will not qualify if you...
- Either foot has less than 2 arterial vessel run-off on Doppler
- Poor visual acuity (registered blind) unless supported by a carer
- Currently participating or recently participated (within 30 days) in another clinical investigation involving a medical device or drug
- Body Mass Index (BMI) over 40
- Uses bespoke contact insoles and footwear
- Unable to use medium or large insoles due to foot size (small or extra large feet)
- Has a pacemaker
- Is pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Royal Free Hospital
London, United Kingdom, NW3 2QE
Actively Recruiting
Research Team
R
Richard Leigh, BSc
CONTACT
L
Lise Pape, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here