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Thirty-eight patients had a first major amputation during the follow-up period.

Among the patients in our study, 15.4% had a first major amputation during follow-up.

Being on renal replacement therapy at the time of inclusion (HR, 3.51 [95% CI, 1.02 12.07]; P = 0.046) was an independent predictive variable for a first major amputation during follow-up in our study.

Secondary endpoint was death or development of PAD defined as any of: loss of foot pulse, development of ankle-brachial index <0.9, lower limb revascularization or major amputation during follow up.

There was no statistical difference in the risk of a first major amputation during the follow-up period between patients who had undergone a minor amputation before inclusion in the study when this factor was included as an additional covariate (HR, 1.21 [95% CI, 0.56 2.59]; P = 0.630) in model 1 of Table 3.

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A total of 231 patients were submitted to major amputations during this period and 17 (7.3%) were rehospitalized due to amputation stump infections of which 5 (29.4%) died within one month.

During the two year follow-up 22 subjects underwent major amputation (major amputation rate during follow-up 3.2%).

32 subjects with diabetic foot in the structured health care group underwent major amputation (amputation above the ankle) during hospital treatment (major amputation rate 4.7%).

The purpose of our study is therefore to report risk factors associated with first major amputation as well as mortality during a long-term observation period of at least 10 years in a cohort of consecutively presenting patients with diabetic foot ulcers.

In a study investigating a large cohort of diabetic foot patients (n = 1,088) treated at centers of excellence in 10 different European countries, the major amputation rate among patients with PAD during a 12-month follow-up was 8%, compared with 2% among patients without PAD (P < 0.001 1313).

A first major amputation occurred in 38 patients (15.4%) during follow-up.

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