Status:
RECRUITING
Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)
Lead Sponsor:
Royal Free Hospital NHS Foundation Trust
Collaborating Sponsors:
Walk With Path
Conditions:
Diabetic Foot
Eligibility:
All Genders
18-100 years
Phase:
NA
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 mo...
Detailed Description
Foot complications in people with diabetes are the most common cause of non-traumatic leg amputation in the UK with over 176 leg, toe or foot amputations every week in England. One in seven people wit...
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06084052
Start Date
April 2 2024
End Date
March 31 2026
Last Update
April 15 2025
Active Locations (1)
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1
Royal Free Hospital
London, United Kingdom, NW3 2QE