Long term outcomes after incident diabetic foot ulcer: Multicenter large cohort prospective study (EDI-FOCUS investigators) epidemiology of diabetic foot complications study: Epidemiology of diabetic foot complications study.

Aims: This long-term prospective study evaluated limb amputation and mortality after the first neuropathic diabetic foot ulcer (DFU).

Methods: A total of 2880 patients with neuropathic DFU (DFU group) and a similar number of patients of diabetes without DFU (nDFU) matched for age and diabetes duration were prospectively assessed at five referral-centers over 14 years. Pre-defined outcome was death during follow-up. Various diabetic co-morbidities and amputation were assessed as mortality predictors.

Results: Overall, 501 (17.4%) patients in DFU group died compared to 89 (3.1%) (p < 0.01) in nDFU group during a median follow-up of 7(1-14) years. The 5- and 10-year mortality was 22% and 71% in the DFU group with a median survival of 7.72 (7.37-8.08) years compared to 3% (p < 0.01) and 5% (p < 0.01) and survival of 12.6 (10.5-12.7) years (p < 0.001) in nDFU group. 29.3% patients had limb amputations. The mortality risk was independent of glycemic control [OR 1.03 (0.80-1.32; p = 0.83)]. However, diabetes duration > 10 years [OR 1.31(1.02-1.70, p = 0.035)], nephropathy [OR 1.47 (1.04-2.09, p < 0.030)], minor 1.85 (1.40-2.44; p < 0.001) or major amputation 2.96 (2.01-4.34, p < 0.001)] predicted mortality.

Conclusions: Every one-in-three individual with neuropathic DFU has amputation and every sixth individual has an early demise. Prevalent nephropathy and incident amputation following DFU predicts mortality.