Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Estimates of diabetes and its burden in the United States. (accessed 17 June 2021)

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Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the medicare database (2015–2018)

02 July 2021
19 min read
Volume 5 · Issue 3



To evaluate large propensity-matched cohorts to assess outcomes in patients receiving advanced treatment (AT) with skin substitutes for lower extremity diabetic ulcers (LEDUs) versus no AT (NAT) for the management of LEDUs. Method: The Medicare Limited Dataset (1 October 2015 through 2 October 2018) were used to retrospectively analyse people receiving care for a LEDU treated with AT or NAT (propensity-matched Group 1). Analysis included major and minor amputations, emergency department (ED) visits and hospital readmissions. In addition, AT following parameters for use (FPFU) was compared with AT not FPFU (propensity-matched Group 2). A paired t-test was used for comparisons of the two groups. For comparisons of three groups, the Kruskal–Wallis test was used. A Bonferroni correction was performed when multiple comparisons were calculated.


There were 9,738,760 patients with a diagnosis of diabetes, of whom 909,813 had a LEDU. In propensity-matched Group 1 (12,676 episodes per cohort), AT patients had statistically fewer minor amputations (p=0.0367), major amputations (p<0.0001), ED visits (p<0.0001), and readmissions (p<0.0001) compared with NAT patients. In propensity-matched Group 2 (1131 episodes per cohort), AT FPFU patients had fewer minor amputations (p=0.002) than those in the AT not FPFU group.


AT for the management of LEDUs was associated with significant reductions in major and minor amputation, ED use, and hospital readmission compared with LEDUs managed with NAT. Clinics should implement AT in accordance with the highlighted parameters for use to improve outcomes and reduce costs.

In 2018 an estimated 10.5% of the US population was affected by diabetes, including approximately 26.8 million people with a diabetes diagnosis and 7.3 million people who were undiagnosed.1 The total cost of managing people with a diabetes diagnosis in the US was estimated at $327 billion in 2017, $90 billion of which was reduced productivity; all costs continue to rise.2

A particularly concerning aspect of diabetes management is diabetic foot ulcer (DFU), which affects about three million patients annually in the US, and accounts for $0.6–4.5 billion in spending through the Medicare programme, rising to $6–$18.7 billion when infection management is included.3 Total Medicare spending for the treatment of DFUs was estimated to be $6.2–18.7 billion annually in 2014.3

More than half of DFUs develop infection, often with osteomyelitis, and up to 20% of infected DFUs require major or minor amputations.4,5 The longer a DFU remains open, the greater the risk for infection, osteomyelitis and amputation.6 In patients with diabetes, 85% of lower-extremity amputations are preceded by a non-healing DFU, and it is estimated that 49–85% of these amputations may be preventable.7,8

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