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Research 2

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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

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