Innovative Treatment of Chronic Diabetic Foot Ulcer in a Controlled Randomized Clinical Trial Produces Fewer Adverse Events, Faster Wound Closure, and Lower Costs

Background: Diabetic foot ulcers (DFUs) are a common complication of diabetes. Non-healing or chronic DFUs are a growing problem associated with wound-related morbidities and high costs. Previously the treatment of chronic DFUs with a cryopreserved placental membrane (commercially known as Grafix®), in a controlled randomized clinical trial was shown to produce a significantly better clinical outcome (i.e., closed more wounds faster) compared to good wound care alone. However, associated costs with the cryopreserved placental membrane treatment has not been analyzed. The purpose of this study was to compare the estimated costs associated with good wound care versus cryopreserved placental membrane treatment in a chronic DFU randomized clinical trial. Material and methods: Estimated costs for good wound care (control) and Grafix® (treatment) were compared for closed vs. not closed DFUs. Using empirically-based national cost estimates for treatments, medications, clinical procedures, adverse events, and serious adverse events, a series of estimated cost comparisons were computed for patients who received the treatment vs. the control. Additionally, the estimated cost of care for patients with closed vs. not closed wounds was compared. Results: The estimated savings for the 50 treatment patients vs. 47 control patients during the trial based on only associated adverse events and serious adverse events were ~$14,000/ patient. When closed (n=41) vs. not closed wounds (n=56) were compared, the estimated costs based on treatments, medications, clinical procedures, and only associated adverse events and serious adverse events for closed wounds were also ~$14,000/patient less for the non-