Monitoring insoles for preventing diabetic foot ulcers
Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)
NA · Royal Free Hospital NHS Foundation Trust · NCT06084052
This study is testing if special insoles that monitor foot temperature and pressure can help people with diabetes avoid foot ulcers better than regular foot care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Royal Free Hospital NHS Foundation Trust (other) |
| Locations | 1 site (London) |
| Trial ID | NCT06084052 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with Type 1 or Type 2 diabetes who are classified as high risk for foot ulceration and can walk independently.
Not a fit: Patients with significant arterial issues in their feet, severe visual impairments, or those with a BMI over 40 may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of foot ulcers in high-risk diabetic patients, improving their quality of life and reducing healthcare costs.
How similar studies have performed: Previous studies have shown promise in using technology for monitoring diabetic foot health, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
London
- Royal Free Hospital — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Richard Leigh, BSc
- Email: richardleigh1@nhs.net
- Phone: +44208302749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Foot, Foot Ulcer Prevention