FUTU Service 2

Research 2

Study no	FUTU 03/02
Short title	Evaluation of education in the secondary prevention of foot ulceration in diabetes - ESP study
Sponsor	Diabetes UK
Background	Foot ulcers commonly recur after healing – approximately 25% within the first month. Even if the skin remains intact for 4 weeks, a third of people get another ulcer within a year. While all patients already receive informal education, with arrangements made for proper foot wear, podiatry and regular medical checks, it is suggested that a formal education programme might reduce the overall rate of recurrence.
Aim of study	To evaluate the implementation of an educational package in preventing ulcer recurrence
Trial design	Three centre, randomised, observer blind trial
Primary endpoint	Ulcer recurrence
Details	175 patients whose foot ulcers remain healed for 4 weeks will be randomized to receive either a one-to-one education programme from a single trained educator (with OT training and specialist experience in the field), or to continue with usual care
Participating centres	Nottingham City Hospital Queens Medical Centre, Nottingham Derbyshire Royal Infirmary, Derby
Lead unit	Foot Ulcer Trials Unit, Nottingham City Hospital
Principal investigator	Dr Kate Radford
Time line	Pilot Phase recruitment started April 2003 Recruitment started July 2002; due to finish May 2005 End of study April 2006
Current situation	Recruitment active at both City Hospital and QMC Extension to DRI planned