Path Active; Safety and Tolerability Study (PASTS)
Diabetic Foot
About this trial
This is an interventional prevention trial for Diabetic Foot
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 diabetes foot Risk Stratification as 'High Risk'. 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. Most 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.
Sites / Locations
- Royal Free HospitalRecruiting
Arms of the Study
Arm 1
Other
Path Active
All participants will use the device. There is no comparator.