Path Active; Safety and Tolerability Study.
Research type
Research Study
Full title
Path Active; Safety and Tolerability Study.
IRAS ID
326601
Contact name
Richard Leigh
Contact email
Sponsor organisation
SBRI Healthcare
Clinicaltrials.gov Identifier
SBRIH22P1028, SBRI Healthcare Selection Panel
Duration of Study in the UK
0 years, 2 months, 14 days
Research 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 30 users, who have been assessed as having a 'high risk' of foot ulceration, over a period of 28 days.
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0080
Date of REC Opinion
18 May 2023
REC opinion
Further Information Favourable Opinion