Patient education for the prevention of diabetic foot ulcers: Interim analysis of a randomised controlled trial due to morbidity and mortality of participants

摘要

This study was designed to explore whether participant-driven patient education in group sessions, compared to provision of standard information, will contribute to a statistically significant reduction in new ulceration during 24 months in patients with diabetes and high risk of ulceration. This is an interim analysis after six months. A randomised controlled study was designed in accordance with CONSORT criteria. Inclusion criteria were: age 35-79 years old, diabetes mellitus, sensory neuropathy, and healed foot ulcer below the ankle; 657 patients (both male and female) were consecutively screened. A total of 131 patients (35 women) were included in the study. Interim analysis of 98 patients after six months was done due to concerns about the patients' ability to fulfil the study per protocol. After a six-month follow up, 42% had developed a new foot ulcer and there was no statistical difference between the two groups. The number of patients was too small to draw any statistical conclusion regarding the effect of the intervention. At six months, five patients had died, and 21 had declined further participation or were lost to follow up. The main reasons for ulcer development were plantar stress ulcer and external trauma. It was concluded that patients with diabetes and a healed foot ulcer develop foot ulcers in spite of participant-driven group education as this high risk patient group has external risk factors that are beyond this form of education. The educational method should be evaluated in patients with lower risk of ulceration.