Incidence and predictors of diabetic foot ulcers in newly diagnosed type 2 diabetes without complications: A prospective longitudinal cohort study.

Gazzaruso, Carmine; Gallotti, Pietro; Pujia, Carmelo; Castagna, Alberto; Falcone, Colomba; Coppola, Adriana · Prim Care Diabetes · 2026

prospective_cohort · Level II

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Abstract

Diabetic foot ulcers (DFU) are a major cause of morbidity and mortality, but data on incidence and predictors in newly diagnosed, uncomplicated type 2 diabetes mellitus (T2DM) are limited. Aim of this longitudinal study was to quantify the incidence of first-ever DFU in newly diagnosed, complication-free T2DM and to identify predictors. A total of 937 newly diagnosed, uncomplicated T2DM patients were enrolled between July 2013 and February 2019 and followed prospectively for 62.7 ± 21.5 months. The primary outcome was the first incident DFU. During follow-up, 48 patients (5.1 %) developed DFU (incidence 0.99/100 person-years). Multivariable Cox regression identified four independent predictors of incident DFU: baseline TcPO₂≤ 46 mmHg (Hazard Ratio -HR-=5.09, 95 %Confidence Interval -95 %CI-:2.68-9.65, p < 0.001), incident retinopathy (HR=6.11, 95 %CI=3.39-11.00, p < 0.001), incident polyneuropathy (HR=7.05, 95 %CI:3.94-12.62, p < 0.001), and incident micro-/macroalbuminuria (HR=2.67, 95 %CI:1.47-4.85, p < 0.001). Sexual dysfunction was more frequent in DFU patients (47.9 % vs. 31.3 %, p = 0.016) but was not an independent predictor. In newly diagnosed, uncomplicated T2DM, reduced tissue oxygenation and early microvascular complications strongly predict DFU. TcPO₂ measurement at diagnosis may help identify high-risk patients who could benefit from targeted foot surveillance and preventive interventions. However, our findings cannot be applied to all T2DM patients due to the specific characteristics of our study population.

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