Clinical Trials Demonstrate That Standard of Care for Diabetic Foot Ulcers May Be Obsolete

In one of the first clinical trials intended to compare the standard of care for diabetic foot wounds against EpiFix, a dehydrated human amnion/chorion membrane allograft (dHACM), researchers found overwhelming evidence for the superior healing properties of EpiFix versus a standard calcium alginate dressing. Results were so compelling that the trial was completed early after treating and observing only 25 of the 80 patients enrolled in the study. After six weeks (three total treatments) of care with EpiFix, greater than 90% of diabetic foot wounds were healed, compared to only 8% healed by the current standard of care. These results were quickly reported in the International Wound Journal and followed up with new clinical research. The original group of patients treated with EpiFix were followed for one-year after the initial study and a remarkable 90% of their wounds remained healed over that time. Patients treated with the standard of care in the first trial were brought back to receive EpiFix dressings. The percentage of healed wounds jumped from 8% to 91% when switching care to the EpiFix skin substitutes. A later study, focusing on EpiFix's efficacy, increased the amount of treatments from once every other week to once every week, producing even more astonishing results. Charles M. Zelen, DPM, FACFAS, Contracted Research: MiMedx