Reducing the impact of diabetic foot ulcers: a pilot trial

niversity Hospitals of Derby and Burton NHS Foundation Trust0 sites20 target enrollmentMay 19, 2021

Overview

No summary available.

Registry

who.int

Start Date

May 19, 2021

End Date

January 7, 2022

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Hospitals of Derby and Burton NHS Foundation Trust

•1\. Has diabetes (according to World Health Organization \[WHO] criteria)
•2\. Aged 18 years or over
•3\. Has two lower limbs (i.e. has not had major amputation of either lower limb)
•4\. Has a recently healed diabetic foot ulcer (if more than one, all must be healed), defined as fully epithelialised with no drainage, for a minimum of 2 weeks
•5\. Has the cognitive capacity to provide informed consent, to engage with the study intervention (both as digital and written handbook versions), to take part in interviews (if randomised to the intervention), and to provide follow\-up data
•6\. Has sufficient command of English language to engage with the intervention and to provide follow\-up data

•1\. Has active Charcot Neuro\-osteoarthropathy
•2\. Presence of active diabetic foot ulceration
•3\. Diagnosis of a current severe mental illness which could hinder engagement with the trial and/or intervention (e.g., psychosis)
•4\. Has previously been randomised to this pilot trial
•5\. Is currently taking part in another study which would affect the outcomes of this study (e.g. diabetic foot ulcer wound healing medicinal product trial or other behavioural intervention study)