Temple University School of Podiatric Medicine Journal Review Club

Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.

Article Title: Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost

Authors: Zelen, Charles; Serena, Thomas; Gould, Lisa; Le, Lam; Carter, Marissa; Keller, Jennifer; Li, William

Journal: International Wound Journal, Volume 13, issue 2, April 2016, Pg 272-282

Reviewed by: Kyle Miller, Class of 2020, Tempe University School of Podiatric Medicine

Introduction

Chronic wounds and ulcerations induced by complications associated with diabetes mellitus have proven to be a burden to the patients themselves, as well as the healthcare system as a whole. This burden has required physicians to not only find interventions that work better, but are also more cost effective. In the population with diabetes, 1 out of 4 will have an ulceration of the lower extremity at some point in their life. It’s also important to state that these foot ulcers can lead to some form of amputation in 20% of these patients. Standard wound care typically involves moist dressings, debridement, wound offloading, infection control, and in some cases, advanced therapies.

The authors of this study looked into two of these advanced therapies, bioengineered skin substitutes (BSS) and dehydrated human amnion/chorion membranes (dHACM.) The primary objective of the study was to see which worked best, as compared to standard wound care (SWC), while the secondary objective was to see which had the lowest costs.

Methods

100 patients were randomized into one of three treatments at a 1:1:1 ratio: bioengineered skin substitutes (BSS), dehydrated human amnion/chorion membranes (dHACM), and standard wound care (SWC) with collagen-alginate dressings. Subjects chosen for this study were 18 years of age or older, diagnosed with either Type I or II diabetes, presented with ulceration 1-25 cm² in size that was unresponsive to standard wound care for ≥4 weeks, showed no clinical signs of infection, and an HgA1c < 12%.

The patients in each group (and between groups) were well matched in regards to comorbidities, blood glucose control, and the location and size of the ulcer being treated. The study was conducted at four outpatient wound care centers in the United States. A two-week run-in period of standard wound care was utilized to screen out any ulcers that were not defined as hard-to-heal by the authors. Once these patients were removed from the study, the treatment phase began. Patients were seen every 7 ± 3 days for up to 12 weeks. Patients in all three groups received ulcer debridement and cleansing with normal saline at each visit. Those in the BSS and dHACM groups had grafts applied weekly after debridement. Patients receiving standard wound care were required to self dress their wounds daily with a collagen-alginate dressing and gauze. All subjects were offloaded with an offloading cast walker.

Results

Overall, dHACM was shown to heal wounds at not only a faster rate, but at a cheaper cost as well. The differences between BSS and SWC was statistically insignificant. dHACM healed, on average, two weeks sooner than the other interventions tested. dHACM was also found to be 83% cheaper than BSS, due to the smaller amount of graft needed per patient. Ten adverse events were recorded during the study. Only two were due to wound infection, both of which were in the standard wound care group. None of the remaining were considered product related.

Discussion

It’s important to remember that there’s no one size fits all treatment for every wound. Physicians must take multiple factors into consideration when planning wound management, including comorbidities, vascular disease, etc. In this study, Zelen et al. add to the mounting evidence that dHACM is one of the better interventions when turning to advanced therapies. Diabetic ulcers treated with dHACM, as opposed to BSS, had not only a higher chance of healing, but also did so more rapidly and more cost effectively. The authors believe that even though dHACM is more expensive than standard wound care in the short-term, the long-term saving will make up for the initial investment.

About the Authors:

Kyle Miller is a second-year student at Temple University School of Podiatric Medicine (TUSPM). He graduated from University of Colorado- Boulder in 2016 with a bachelor of arts in Biochemistry. Upon starting school at TUSPM he has become involved with a multitude of clubs and currently holds officer positions in the American Public Health Association Club and Journal Club. Kyle is interested in reconstructive surgery, limb salvage and diabetic wound care. Dr. James McGuire is the director of the Leonard S. Abrams Center for Advanced Wound Healing and an associate professor of the Department of Podiatric Medicine and Orthopedics at the Temple University School of Podiatric Medicine in Philadelphia.