OBJECTIVES: Diabetic polyneuropathy (DPN) is a common complication in patients with diabetes mellitus, causing sensory disturbance primarily in the limbs, especially the feet. As a consequence, DPN might lead to diabetic foot ulceration, gangrene, and subsequent amputation. This study aimed to analyze the real-world, population-based incidence of amputations in patients with painful and non-painful DPN.

METHODS: This population-based analysis utilized anonymized, age- and sex-adjusted claims data from German payers between 2014 and 2019, encompassing approximately 4.9 million insured individuals. Patients with documented diabetes mellitus were selected and categorized as having no DPN, painful, or non-painful DPN. Patients with claims indicating back pain or knee arthroplasty were excluded. One-year amputation incidence rates were calculated using inpatient claims, and group comparisons were performed using chi-square with Yates correction and a two-sided p-value of 0.05.

RESULTS: 346,268 patients with diabetes without DPN, 30,552 patients with painful DPN, and 39,684 patients with non-painful DPN were included. Incidence of amputations was significantly higher in patients with DPN (n=1,415; 1.6%) compared to those without DPN (n=268; 0.1%) (p<0.001). Furthermore, patients with PDN had a higher amputation rate (n=743; 2.4%) compared to patients with non-painful diabetic polyneuropathy (n=534; 1.3%) (p<0.001).

CONCLUSIONS: This population-based analysis demonstrated a significantly elevated 12-months incidence of amputations among patients with painful DPN compared to those with non-painful DPN or without DPN. These findings underscore the detrimental impact of DPN on amputation risk and emphasize the importance of early detection and effective management of this condition. Additionally, the results highlight the potential role of pain as a contributing factor in the severity and progression of DPN-related complications.