Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)
Recruiting
N/A
Interventional Study
Diabetic Foot
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 120 (estimated)
- Sponsor
- Royal Free Hospital NHS Foundation Trust · Other
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About This Trial
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 mul…
Trial Locations
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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 diabete…
Contacts