Research Article
Innovative Treatment of Chronic Diabetic Foot Ulcer in a Controlled Randomized Clinical Trial Produces Fewer Adverse Events, Faster Wound Closure, and Lower Costs
Eugene J Nuccio1*, Lawrence A Lavery2 and Sung-Joon Min11University of Colorado, Anschutz Medical Campus, USA
2Texas A and M University Health Science Center College of Medicine, USA
- *Corresponding Author:
- Eugene J Nuccio
University of Colorado, Anschutz Medical Campus
13199 E. Montview Blvd., Suite 400, Aurora
CO 80045-7201, USA
Tel: 3037242479
Fax: 3037242530
E-mail: Eugene.nuccio@ucdenver.edu
Received date: July 04, 2016; Accepted date: August 27, 2016; Published date: September 05, 2016
Citation: Nuccio EJ, Lavery LA, Min SJ (2016) Innovative Treatment of Chronic Diabetic Foot Ulcer in a Controlled Randomized Clinical Trial Produces Fewer Adverse Events, Faster Wound Closure, and Lower Costs. J Clin Diabetes Pract 1:110.
Copyright: © 2016 Nuccio EJ et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
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 have 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-closed wounds. Conclusions: The lower costs were associated with patients treated with Grafix® and were driven by fewer adverse events, fewer serious adverse events, and fewer hospitalizations due to closing wounds faster.