Lincoln NB, Radford KA, Game FL, Jeffcoate WJ, et al.
Diabetologia. Date of publication 2008 Nov 1;volume 51(11):1954-61.
1. Diabetologia. 2008 Nov;51(11):1954-61. doi: 10.1007/s00125-008-1110-0. Epub 2008
Aug 30.
Education for secondary prevention of foot ulcers in people with diabetes: a
randomised controlled trial.
Lincoln NB(1), Radford KA, Game FL, Jeffcoate WJ.
Author information:
(1)Institute of Work, Health and Organisations, University of Nottingham,
Nottingham, UK.
AIMS/HYPOTHESIS: This observer-blind, randomised controlled trial was designed to
determine the effect of a foot care education programme in the secondary
prevention of foot ulcers.
METHODS: People with newly healed foot ulcers attending one of three specialist
clinics were allocated to receive either targeted, one-to-one education or usual
care, using a computer-generated random allocation sequence that had been
prepared in advance but which was concealed from the clinical researcher. The
primary outcome was ulcer incidence at 12 months. Secondary outcomes were ulcer
incidence at 6 months and incidence of amputation, mood (Hospital Anxiety and
Depression Scale) and quality of life (Diabetic Foot Ulcer Scale) at 6 and 12
months. Protective foot care behaviours (Nottingham Assessment of Functional
Footcare) were assessed at 12 months.
RESULTS: There were 87 (mean [SD] age 63.5 [12.1] years) patients in the
intervention group and 85 control patients (mean [SD] age 64.9 [10.9] years). The
groups were comparable at baseline. No significant differences (p > 0.05) were
observed between groups in ulcer incidence at either 6 months (intervention 30%,
control 21%) or 12 months (intervention 41%, control 41%). Recommended foot care
behaviours at 12 months were better in the intervention than in the control group
(p = 0.03), but education had no significant (p > 0.05) effect on mood, quality
of life or amputations.
CONCLUSIONS/INTERPRETATION: Even though the intervention was associated with
improved foot care behaviour, there was no evidence that this programme of
targeted education was associated with clinical benefit in this population when
compared with usual care. The usefulness and optimal delivery of education to
such a high-risk group requires further evaluation.
TRIAL REGISTRATION: ClinicalTrials.gov NCT00729456 FUNDING: Diabetes UK project
grant RD02/0002535.
DOI: 10.1007/s00125-008-1110-0
PMID: 18758747 [Indexed for MEDLINE]
