Health care impact of lower extremity amputations in diabetes mellitus derived from Dutch insurance claims; design of the retrospective cohort study; Dutch diabetes estimate-amputation initiative (DUDE-8)

Introduction: Many individuals with diabetes mellitus (DM) experience complications that significantly impact their quality of life and life expectancy. Foot complications, arising from neuropathy, macroangiopathy, and metabolic derangements, or a combination of these factors, are a major concern. The combination of these disorders increases the risk of developing diabetic foot ulcers (DFUs), which in turn can lead to lower extremity amputations (LEAs) if not promptly and adequately treated. Globally, 80% of all nontraumatic LEAs are due to DM, and most of these were preceded by a nonhealing DFU. Studies in the Netherlands have explored the incidence of LEA in the diabetic population, reporting a range from 78 to 704 per 100 000 person-years. The current design focuses on utilizing the available all-claims data to gain valuable insights into amputation rates among individuals with DM in the Netherlands during the years 2013-2019 and develop a more comprehensive understanding of the current Dutch situation. Methods and analyses: In the Netherlands, all amputations are performed in hospitals, allowing for comprehensive financial claims data. The current project focuses on utilizing the available all-claims data to gain insights into yearly LEA rates among individuals with and without DM in the Netherlands. Over the period 2013-2019, various predefined analyses will be performed, including costs and outcomes. Individuals will be matched based on age, gender, and, where applicable, socioeconomic status. Depending on the research questions, additional analyses will take place on epidemiology, healthcare use, costs, and mortality rates.