In a recently published study involving Medicare patients with diabetic foot ulcers, researchers found that the use of dehydrated human amnion/chorion membrane (DHACM) led to less emergency department visits, hospital admissions and lower extremity amputations in comparison to standard-of-care treatment.
The authors of the retrospective study, published in the Journal of Wound Care, found that DHACM (MiMedx) also significantly reduced long-term healthcare-related costs in comparison to standard of care without any advanced therapy, according to propensity-matched cohorts drawn from a larger cohort of more than 1.2 million Medicare patients with DFUs.
“There are abundant data that suggest that placental-based products improve healing in DFUs,” notes David G. Armstrong, DPM, MD, PhD, the President of the American Limb Preservation Society (ALPS) and a co-author of the study. “This is likely due to their immunomodulatory/anti-inflammatory properties.”
“DHACM possesses a number of characteristics that enhance healing of DFUs. Most notably, it provides a matrix for cellular migration and proliferation, and contains many growth factors and cytokines important for wound healing,” points out Adam Isaac, DPM, FACFAS, the Director of Research with Foot and Ankle Specialists of the Mid-Atlantic. “In addition, the fact that it comes in a dehydrated form means that it is easily transported and can be stored at room temperature for up to five years.”1
The study noted that DHACM was the mostly widely utilized advanced treatment modality for DFUs in this Medicare population at more than double the rate of the next closest advanced therapy.
“Whenever we evaluate the use of advanced wound care for diabetic foot ulcers, efficacy as demonstrated by high quality clinical research studies should be the most important factor,” says Dr. Isaac. “There is also the reality of treating patients in a predominantly fee-for-service model, and cost-reimbursement considerations inevitably play a significant role in modality selection.”
In light of the study findings demonstrating reduced major amputations, emergency department visits and readmission to hospitals, when should clinicians consider the use of DHACM in their treatment armamentarium for DFUs?
“In situations in which diabetic foot ulcers are not responding as expected to standard care (i.e. evidence-based wound care, appropriate offloading, revascularization (if indicated), and infection control), providers must consider an advanced wound care modality such as DHACM,” explains Dr. Isaac.
The study revealed that over 90 percent of cases treated with DHACM did not follow parameters for use. Researchers also noted that the average start date for initiating advanced treatment was at 80.8 days. Yet the established parameters for initiating an advanced therapy were 30 to 45 days after diagnosis with subsequent applications at seven- to 14-day intervals.
“We likely do not use these therapies early enough or at the correct dosing interval,” suggests Dr. Armstrong, a Professor of Surgery at the Keck School of Medicine at the University of Southern California, and Director of the Southwestern Academic Limb Salvage Alliance (SALSA). “Companion diagnostics might ultimately help us in the ‘if this, then this’ decision-making.”
Dr. Isaac says it is important to keep the costs of advanced modalities in perspective. Beyond direct costs for treatment, Dr. Isaac notes the costs for patients who may require extended time off work or depend on family and loved ones to assist in care not to mention recurrence of DFUs, hospitalization and amputation that can occur within a relatively short time period.
“It is critical that providers, patients, payors and health systems gain a better understanding of the magnitude of costs associated with diabetic foot complications,” emphasizes Dr. Isaac. “… When you factor in all of these things — and it really represents the tip of the iceberg — it puts into perspective how important it is to get these patients healed quickly and keep them healed. If an advanced treatment like DHACM can decrease complications, reduce costs, and lower resource utilization, then the question really becomes: why not use something like DHACM?”
1. Zelen CM, Serena TE, Denoziere G, Fetterolf DE. A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J. 2013;10(5):502-7.