Epidemiology

The prevalence of diagnosed diabetes mellitus in adults in the US increased from 7.1% in 2001-2004 to 10.1% in 2017-2020.[3][4]​​ In 2021, the number of people of all ages in the US with diagnosed or undiagnosed diabetes was estimated to be 38.4 million (11.6% of the US population). Globally in 2021, there were estimated to be 529 million people living with diabetes, equivalent to 6.1% of the world’s population.[5]

Up to 34% of people with diabetes will develop a diabetic foot ulcer, and at least half of these wounds will develop some form of infection, increasing the risk for hospitalization and amputation.[6] In the US, the incidence of lower-extremity amputation was 6.8 per 1000 people with diabetes in 2020.[4] Globally in 2016, some 131 million people were estimated to be living with diabetes-related lower-extremity complications, equivalent to 1.8% of the global population, with males and people ages 50-69 disproportionately affected.[7] Diabetes is the most common cause of nontraumatic limb amputation, with foot ulcers preceding more than 80% of amputations.[8]

Peripheral sensory neuropathy and peripheral artery disease (PAD) in patients with diabetes have an important role in the development of diabetic foot ulcers and risk of limb loss.[9] The prevalence of sensory neuropathy in diabetic populations is between 40% and 60%.[9] The prevalence of PAD in people with diabetes is 20% to 28%, rising to 50% among those with established diabetic foot ulcers.[10]

In one prospective cohort study of patients with diabetes without ulceration at enrollment, the incident rate of diabetic foot ulcers was 5.0 in 100 person-years.[11] In a UK national audit, almost 40% of people with diabetic foot ulcers had a foot disease-related hospital admission within 6 months of their first specialist foot care assessment.[12] In a large analysis of ambulatory care visits in the US, people attending with diabetic foot ulcers and infections had markedly higher rates of hospitalization and onward referral to other physicians, compared to people attending with other conditions.[13]

Unfortunately, significant treatment variability has been identified both in the US and Europe. Only 27% of patients who had a diabetic foot ulcer for 3 or more months in duration were referred for specialty care in the multicenter, prospective EuroDIALE study, and only 40% of those with peripheral artery disease were referred for vascular imaging or revascularization.[14]

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