Effectiveness of podiatry to prevent foot ulcers in diabetic patients with polyneuropathy

INTERVENTION: After randomisation, patients in the intervention group made an appointment with a participating local podiatrist within 2 weeks. These podiatrists (n = 20) were alumni of the School for Podiatry in Eindhoven, the Netherlands and were trained additionally for the purpose of this study. Subjects were instructed to visit the podiatrist for examination and treatment of their feet twice a year or more often as needed during the 3 year study period. Podiatric care included removal of callus, trimming nails, application of nail braces, prescribing insoles, orthotic toe devices and other off‐loading techniques as well as shoe adjustments. Moreover, education and advice about foot care and shoe wear were given at each visit. Clinical findings and applied therapeutic procedures were recorded. In the control group extra podiatric consultations in case of (pre‐)ulceration were allowed as well as treatment as usual. Follow‐up and care for their diabetes were continued as usual for both intervention and control group patients. CONDITION: Diabetic foot ; Nutritional, Metabolic, Endocrine ; Non‐insulin‐dependent diabetes mellitus PRIMARY OUTCOME: 1. Development of a foot ulcer during the 3‐year follow‐up period; 2. Number of ulcer related procedures in the 3‐month period after the first detection of an ulcer SECONDARY OUTCOME: 1. Severity of the ulcer; 2. Healing time; 3. Major interventions; 4. Hospitalisation days related to ulceration; ; Measured at the onset of ulceration and after 3 month after onset of ulceration. INCLUSION CRITERIA: 1. Patients aged over 18 years, either sex 2. Diabetes mellitus 3. Signs of peripheral polyneuropathy. Polyneuropathy is defined as absence of pressure sensation (10 gram Semmes Weinstein monofilament) and/or absence of the vibration perception sense (128 Hertz tuning fork).