Monitoring insoles for preventing diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of Path Active™, a pair of monitoring insoles designed to measure temperature and pressure in the feet of individuals with diabetes at high risk for foot ulceration. The insoles connect to a mobile app and a clinical dashboard, providing alerts for early signs of skin damage. The study will compare outcomes in 60 participants using Path Active™ against 60 participants receiving standard podiatry care over a 12-week period. The goal is to determine if these insoles can reduce the incidence of foot ulcers and the need for frequent podiatry appointments.

Why it matters

Who can join: the full rules

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 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 Criteria:

* 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.

Where it's running

• Royal Free Hospital
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Richard Leigh, BSc
• Email: richardleigh1@nhs.net
• Phone: +44208302749

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.