How US Medicare demonstrates clear reductions in amputations, emergency visits, readmissions regards the use of skin substitutes

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

New study shows advanced treatment for management of LEDUs (lower extremity diabetic ulcers) among Medicare beneficiaries is associated with significant reductions in major and minor amputation, emergency department (ED) use, and hospital readmissions vs. LEDUs managed without advanced therapies.

MiMedx announced publication of its peer-reviewed study in the Journal of Wound Care (JWC), addressing the observed impact of Advanced Treatment (AT) using all high-cost skin substitute products in lower extremity diabetic ulcers (LEDUs) based on data from Medicare spanning October 1, 2015 through to October 2, 2018. The study assessed outcome in patients receiving advanced therapies with all high-cost skin substitute products, as designated by the Centres for Medicare and Medicaid Services (CMS), for LEDUs versus No Advanced Treatment (NAT), and found that advanced therapies used could lead to a 42% reduction in major and minor amputations and all related costs, compared to no advanced therapies. Further, the study highlights preferable outcomes when advanced therapies follows parameters for use (FPFU), underscoring the importance of early treatment with regular intervals and well-defined treatment guidelines.

“The data derived from this study are important for a number of reasons,” noted Dr. David G. Armstrong, Professor of Surgery and Director of the Southwestern Academic Limb Salvage Alliance (SALSA) at the Keck School of Medicine of the University of Southern California. “Most notably, it is the first, to our knowledge, to broadly evaluate the parameters for use and associated observed impact of these advanced treatments in the wound care space. The substantial reduction, not only in amputation, but also in hospital readmission rates and visits to the emergency room suggests that our patients may be able to live more hospital-free and activity-rich days when we focus on getting to wound closure.”


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.


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.


Timothy R. Wright, MIMEDX Chief Executive Officer, commented, “As a company dedicated to advancing scientific and health economic research that informs and improves patient care and outcomes, we see these analyses as providing crucial validation that advanced treatment can reduce the suffering and expenses caused by chronic LEDUs. Future research must build upon these findings and inform better treatment guidelines and reimbursement policies, so that together, we raise the standard of care for patients with LEDUs.”

What does this look like for the UK?

How could this impact on the UK and the use of Advanced therapies for wound healing? The debate needs to open further and more consideration for the adoption of these technologies that have a clear place in closing wounds. The use of these therapies in the UK is evolving slowly, It would be useful to raise the debate further amongst UK wound specialists and look to examples such as TIMERS: hard to heal wounds as examples of how these technologies can be adapted here in the UK to great effect. 


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