What Does A New Study Reveal About Advanced Treatment For Lower Extremity Diabetic Ulcers?

Amputations are a grave concern among people living with diabetes. Almost half of all patients with diabetes that underwent minor amputation, and more than half of those with a major amputation, saw a significant increase in five-year mortality rates.

Reducing these events should be our shared goal. It’s in the best interests of our patients and would also have a positive, long-term effect on overall healthcare burden by decreasing costs, evidenced by 2010 estimates of $60,000 per patient amputation, with care costs in the year following an amputation of $44,200.¹

A new, peer-reviewed study published in the Journal of Wound Care, for which I am co-author, shows a path forward. It addresses the observed impact of advanced treatment – defined as all high-cost skin substitute products – used to treat chronic, lower-extremity diabetic ulcers (LEDUs) based on data from the Medicare Limited Dataset (October 1, 2015, through October 2, 2018).² Assessing outcomes in patients receiving advanced treatment with all high-cost skin substitute products, as designated by the Centers for Medicare and Medicaid Services, for LEDUs versus no advanced treatment, the study found that the use of advanced treatment could lead to a 42 percent reduction in major and minor amputations and all related costs, compared to no advanced treatment.²

The study also highlights preferable outcomes when employing advanced treatment according to defined parameters for use – initiating the advanced treatment within 30 to 45 days of diagnosis and reapplying every seven to 14 days – underscoring the importance of early treatment at regular intervals and with well-defined treatment guidelines. A troubling finding in regard to these parameters of use is less than 10 percent of patients treated with advanced treatments received them in such a manner.²

For example, those receiving advanced treatment had lower levels of emergency department (ED) use, hospital readmissions, and amputations throughout the study period. The reduction in healthcare use and subsequent spending could be greatest among patients receiving advanced treatment following these parameters for use. Furthermore, by experiencing decreased health resource use and avoiding amputations, patients who receive advanced treatment following parameters for use may also have a higher quality of life.

The optimal positive impact on amputation and health care use rates observed in our research can take place by increased payor and provider education in all settings to encourage timely, routine advanced treatment while following parameters for use. The resultant decrease in ED and inpatient services  would greatly alleviate the financial, physical, and emotional burdens for patients and their caregivers, and reducing major amputations has a long-term effect on minimizing significant economic burdens associated with diabetes. For example:

• 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.³

• DFUs create significant economic burdens, accounting for up to $4.5 billion in Medicare spending.⁴

• In 2014, Medicare spending for the treatment of DFUs was an estimated $6.2–18.7 billion when the cost of infection management is included.⁴

• The annual payor burden of DFU treatment ranged from $9.1–13.2 billion, in large part due to increased hospitalizations, home healthcare needs, emergency department visits, and outpatient or physician office visits.⁵

Our study, which was a retrospective analysis of the Medicare Database of Lower Extremity Diabetic Ulcers from 2015 to 2018 found fewer minor and major amputations when advanced treatment began within 30 to 45 days of the first clinic visit, and once initiated, applications took place every seven to 14 days. One of our most surprising findings was that only approximately 20 percent of patients that had a diabetic ulcer during that time received an advanced treatment, despite availability.²

There is a need to generate better policies, update reimbursement, and raise the standard of care for patients with LEDUs. This is critical: the longer a LEDU is in treatment, the higher the probability that the event results in an amputation, which occur most frequently during the first 50 days after diagnosis, approaching 20 percent in medium and high Charlson Comorbidity Index (CCI) patients, while an amputation rate just over five percent was observed for low CCI patients. Based on our study’s results, I believe clinics should implement advanced treatment in accordance with the highlighted parameters for use to improve outcomes and reduce costs. Given these findings, the value of beginning advanced treatment in proximity to a patient’s diagnosis is worthy of reassessment.

To my knowledge, this is the first study to broadly evaluate the parameters for use and associated observed impact of these advanced treatments in the wound care space. Understanding the health outcome and financial implications of different courses of treatment is essential to improving patient health and reducing cost burden to providers, patients, families, payors, and the healthcare system overall. These data demonstrate the significant beneficial impact of advanced treatment with all high-cost skin substitute products for difficult-to-heal LEDUs, and the additional benefit of treating quickly and regularly with advanced treatment.

These analyses also provide crucial validation that advanced treatment can reduce the suffering and expenses caused by chronic LEDUs. My hope is that this and future research will inform better treatment guidelines and reimbursement policies with the goal of decreasing the number of lower extremity amputations and raising the standard of care for patients.

Dr. Tettelbach is a Fellow of the American College of Physicians, the Infectious Diseases Society of America, and the Undersea Hyperbaric Medicine Society. He is a Certified Wound Specialist and a Board Member of the Association for the Advancement of Wound Care. He is the Medical Director of Wound Care and Infection Prevention at the Western Peaks Specialty Hospital in Bountiful, Utah and the Encompass Health and Rehabilitation Hospital of Utah in Salt Lake City, Utah.

Dr. Tettelbach discloses that he is the Principal Medical Officer of Medical Affairs for MIMEDX.

References

1. Rothenberg GM, Page J, Stuck R, Spencer C, Kaplan L, Gordon I. Remote Temperature Monitoring of the Diabetic Foot: From Research to Practice. Fed Pract. 2020; 37(3):114-124. Cited by: Armstrong DG, Tettelbach WH, Chang TJ, et al. Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015–2018). J Wound Care. 2021;30(Sup7):S5 -S16. doi:10.12968/jowc

2. Armstrong DG, Tettelbach WH, Chang TJ, et al. Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015–2018). J Wound Care. 2021;30(Sup7):S5 –S16. doi:10.12968/jowc.2021.30.Sup7.S5

3. American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018;41(5):917-928. doi:10.2337/dci18-0007

4. Nussbaum SR, Carter MJ, Fife CE, et al. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Value Health. 2018;21(1):27-32. doi:10.1016/j.jval.2017.07.007

5. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers [published correction appears in Diabetes Care. 2014 Sep;37(9):2660]. Diabetes Care. 2014;37(3):651-658. doi:10.2337/dc13-2176