EpiFix Best Treatment for Chronic Lower Extremity Diabetic Ulcers
By Will Boggs MD
NEW YORK - EpiFix is superior to Apligraf and standard wound care for healing chronic lower extremity diabetic ulcers, according to a new clinical trial.
"The findings from this study are so important because it is the first multicenter randomized comparative-effectiveness study that demonstrated a significant clinical difference by examining, side by side, the performance, outcomes, and utilization of two advanced wound-care products (Apligraf and EpiFix) as a treatment for chronic lower extremity diabetic ulcers," said Dr. Charles M. Zelen from Professional Education and Research Institute in Roanoke, Virginia.
"Our study showed the healing was markedly faster, more complete, and more cost-effective with EpiFix," told Reuters Health by email.
EpiFix is an allograft from MiMedx Group, Inc., which funded the study. The product consists of layers of the amniotic sac and is regulated by the U.S. Food and Drug Administration as a human cells, tissues, and cellular and tissue-based product, Dr. Zelen and colleagues report in the International Wound Journal, online November 26.
Apligraf from Organogenesis, Inc. is a class III medical device supplied as a living, allogeneic bi-layered cultured skin substitute derived from donated human neonatal male foreskin tissue.
The researchers compared rates of healing, time to wound closure, product cost, and efficiency of product utilization in the treatment of chronic diabetic lower extremity wounds with standard wound care, dehydrated human amnion/chorion membrane (dHACM, EpiFix), or Apligraf in a study of 60 patients.
By week four of treatment, complete healing had occurred in 85% (17/20) patients receiving EpiFix, 35.0% (7/20) patients receiving Apligraf, and 30% (6/20) patients receiving standard care, the team found (p=0.001 for EpiFix versus Apligraf and for EpiFix versus standard care).
By six weeks, complete healing rates had reached 95% with EpiFix, compared with only 45.0% with Apligraf (p=0.0006) and 35% with standard care (p=0.0001).
Mean percent wound size reductions were greatest in weeks 1 through 6 with EpiFix, and estimated median healing time was significantly faster with EpiFix (13 days) than with Apligraf (49 days) or standard care (49 days).
As a result of trimming for wound size, 97.1% of the Apligraf product and 55.8% of the EpiFix product was discarded. The total cost of the Apligraf used in the study was $184,315 ($9,216 per patient), compared with $33,379 ($1,669 per patient) for EpiFix, an 81.9% reduction.
"This is very exciting data that should impact the day-to-day choices we make in treating patients with diabetic wounds," Dr. Zelen said. "Most diabetics presenting to physicians like myself who are wound care experts find these patients have already tried some type of treatment which has not worked, so there is no reason to wait before using EpiFix as an advanced treatment."
"Standards of care in any therapeutic category can shift over time as new technologies such as EpiFix are available to physicians," Dr. Zelen said. "This multi-center study gives physicians the evidence they need to adjust their standards for treating diabetic foot ulcers, venous leg ulcers, and other wounds and offer their patients this advanced treatment."
A number of Dr. Zelen's co-authors reported financial ties to MiMedx.
In email to Reuters Health, Kirsten Dupuis, executive assistant to Geoff MacKay President & CEO of Organogenesis, said, "The results of the study are so obviously anomalous and inconsistent with the large existing body of literature on wound healing, which casts severe doubt on the reliability of the findings. A wound healing rate of 95% after six weeks is implausible and suggests a fundamental deficiency with aspects of the study design or an inherent bias. In addition, the cost-savings claims stated in the study are simply incorrect, as the flagrant overuse of Apligraf in the trial greatly inflates the cost of product that is needed to effectively heal diabetic foot ulcers."
Dr. Mayer Tenenhaus, a plastic and reconstructive surgeon from the University of California, San Diego Medical Center, emphasized the importance of optimizing basic care before using advanced products.
"It is my opinion that the fundamentals continue to be considered the standard of care -- prevention, education, nutrition, judicious and meticulous wound bed preparation, optimizing comorbidities, glucose control, edema control, protecting surrounding skin, minimizing trauma, prevention, optimizing moisture balance (not too dry, not too wet), improving vascular status, etc," he told Reuters Health by email. "The reason I say this is that putting a biologic on a poorly optimized wound or patient is doomed to failure; it wastes the patient's time (and) money and risks further complications."
"(B)iologics and biosynthetics show great promise, and my experience with EpiFix has similarly been very positive in a wide variety of wound applications," Dr. Tenenhaus said. "With that said, I would generally suggest that if the wounds do not respond well to the aforementioned fundamentals in a timely fashion then one must consider altering tack, and it is here that I would envision the application of biologics. The costs are great and cannot be ignored."
SOURCE: https://bit.ly/1ymYw5Q
Int Wound J 2014.
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