BACKGROUND: Neuropathic foot ulcers are among the major health problems faced by patients with diabetes mellitus. OBJECTIVE: To evaluate the preventive efficacy of a therapeutic education and protective footwear program in the incidence and recurrence of neuropathic ulcers due to diabetes. METHODS: Fifty-three patients with diabetes and neuropathy from a public healthcare unit in Porto Alegre, Rio Grande do Sul, took part in a clinical trial for two years. The participants were randomly allocated to an intervention group (n = 30) or a control group (n = 23). Therapeutic education was provided in group sessions, and protective footwear was supplied in accordance with individual prescriptions. The nonparametric Mann-Whitney test was used to determine differences in incidence and recurrence of ulceration between the groups. Life-table analysis and the Kaplan-Meier method were used to measure the duration of ulcer-free survival. RESULTS: In the intervention group, the ulcer incidence rate was 38.1% compared to 51.1% in the control group. Among the participants who presented ulcers, 83% were in the control group and 16.7% in the intervention group. After one year, the participants in the intervention group had a 75% chance of being ulcer-free, compared with 61% in the control group, and these percentages reduced to 60% and 52% respectively after two years. There was a tendency toward shorter survival among the control group participants. CONCLUSION: Although the proposed program lowered recurrence rates and increased the duration of ulcer-free survival, it was unable to prevent occurrence and recurrence of neuropathic ulcers due to diabetes. Identification number in the Australian New Zealand Clinical Trials Registry ACTRN12609000693224.

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