We recently spoke with William Tettelbach, MD, FACP, FIDSA, FUHM, FAPWCA, CWS, co-author of study published in the Journal of Wound Care that assessed outcomes in patients receiving advanced treatment with skin substitutes for lower extremity diabetic ulcers (LEDUs) versus no advanced treatment for the management of LEDUs.

PW: How would you characterize the population of patients with diabetic foot ulcers (DFUs)?
WT: In 2018, an estimated 3 million Americans had DFUs, a type of LEDU. Among patients with DFUs, more than one-half will develop an infection, up to 20% of which require major or minor amputations. The immediate physical and economic toll on people with diabetic lower extremity complications, including amputations, have been correlated to an increased 5-year mortality rate.

PW: What is the cost burden to the healthcare system attributed to DFU care?
WT: DFUs create significant economic burden, accounting for up to $4.5 billion in Medicare spending and up to $18.7 billion when the cost of infection management is included. In 2014, Medicare spending for the treatment of DFUs was an estimated $6.2-$18.7 billion. The annual payor burden of DFU treatment ranged from $9.1-$13.2 billion, in large part due to increased hospitalizations, home healthcare, emergency department (ED) visits, and outpatient or physician office visits.

PW: How can the Standard of Care (SOC) be elevated for patients with DFUs?
WT: The SOC for patients with diabetic ulcers can be elevated by adopting best practices that reduce the burden on the healthcare system while improving or preserving the patient’s quality of life. Our study identified practices that significantly reduce DFU and, more generally, LEDU-related amputations and healthcare use. The US population is getting older, and the frequency of diabetes is increasing. Notably, this disease affects US veterans and Medicare beneficiaries disproportionately. Without adopting best practices, we will most likely see a rise in preventable amputation, which research shows increases a mortality rate that is higher than that of several types of breast, colon and prostate cancers. There is a need to generate better policies, update reimbursement, and raise the SOC for patients with LEDUs.

PW: What did your study assess?
WT: The study assessed outcomes in patients receiving advanced treatment (AT)—which, for the purpose of the study, was defined as any high-cost skin substitute products, as designated by CMS—for LEDUs versus no advanced treatment (NAT). We found that AT use could lead to a 42% reduction in major and minor amputations and all related costs compared with NAT. Further, the study highlights preferable outcomes when AT follows parameters for use (FPFU), underscoring the importance of early treatment with regular intervals and well-defined treatment guidelines.

PW: What are some other key findings of the study?

  • Patients with diabetes who were treated with AT for an LEDU were noted to have undergone significantly fewer minor amputations and experience a 50% reduction in major amputations compared with those treated with NAT. They were also observed to have significantly fewer readmissions compared with those treated with NAT.
  • The preponderance of clinicians who do not FPFU (~90.8%) when using AT may lead to skewed opinions of the performance and cost-benefits of AT in the healthcare system. Notably, AT had demonstrably better outcomes and statistically equivalent lengths of treatment.
  • The value of beginning AT in proximity to the diagnosis should be reassessed given our finding. The optimal positive impact on amputation and healthcare use rates observed in this study can be achieved by increased payor and clinician education in all settings to encourage timely and routine use of AT while FPFU.

PW: How does this study build an economic path toward elevating the SOC for patients with DFUs?
WT: This was a study that, for the first time ever, broadly evaluated the parameters for use and the associated impact of advanced treatments in the wound care space. Those receiving AT had lower levels of ED use, readmissions, and amputations throughout the study period. The reduction in healthcare use and subsequent spending, could be greatest among patients who received AT FPFU. These patients had the lowest levels of each type of use, reducing many of their costs. Reducing major amputations has a long-term effect on ongoing health costs, estimated in 2010 at $60,000 per patient amputation, with care costs in the year following of $44,200. Furthermore, by preventing health resource use and amputations, patients who receive AT FPFU may also have a higher quality of life. Understanding the health outcome and financial implications of different courses of treatment is essential to improving patient health and reducing cost burden to clinicians, patients, families, payors, and the healthcare system overall.