Path Active; Safety and Tolerability Study — PASTS  

Diabetic Foot Clinical Trial

Official title: Path Active; Safety and Tolerability Study

Status Completed

Clinical Trial 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 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 will assess safety and tolerability of Path Active™ in 10 users, who have been assessed as having a 'high risk' of foot ulceration, over a period of 7 days.

Clinical Trial 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 with diabetes will develop a foot ulcer at some stage in their lives. Not only does this impair their daily activities and reduce their quality of life, it also increases their risk of amputation by up to 24-fold. Five year mortality for minor and major amputations in diabetes have been reported as 46.2% and 56.6%, respectively. Circulatory problems, nerve impairment and infection contribute to foot complications in diabetes. Prior to a foot ulceration, changes in temperature and/or pressure occur. These early warning signs can be measured by Path Active™ and alert the wearer via a mobile phone app and the clinician via a clinical dashboard so that preventive action can be taken. Currently people with diabetes who have been assessed as 'high risk' for foot ulceration are allocated appointments with podiatrists in 'foot protection teams' who review on a weekly to monthly basis. Path Active™ has the potential to reduce appointments by alerting podiatry teams to potential problems as they occur rather than regular routine reviews. Path Active™ may be able to reduce hospital and clinic visits and thereby reduce healthcare carbon footprint.

The primary objective of this clinical investigation is to evaluate the safety and tolerability of Path Active™ in people with diabetes who are at 'high risk' of foot ulceration. ;

Related Conditions & MeSH terms

• Diabetic Foot

• NCT number: NCT06084052
• Study type: Interventional
• Source: Royal Free Hospital NHS Foundation Trust
• Status: Completed
• Phase: N/A
• Start date: August 1, 2023
• Completion date: November 24, 2023