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: A Pilot Study to Evaluate the Effects of Perfusion-decellularized Porcine Hepatic-derived Wound Matrix on Difficult-to-heal Diabetic Foot Ulcers
Authors: Robert Fridman, DPM, FACFAS, CWSP; and Jonathan Engelhardt
Journal Name and Issue: WOUNDS Vol. 29 (10), 317-323, October 2017.
Reviewed by: Ryan Lazar, Class of 2020, Temple University School of Podiatric Medicine

Introduction

Twenty-five percent of all diabetic patients will develop a diabetic foot ulcer (DFU), the major reason for hospitalizations in diabetic patients. The current standard of care (SOC) for DFUs consists of debridement, glycemic control, antimicrobial therapy, and imaging. DFUs often become infected, and with improper healing they require more advanced care and possibly lower extremity amputation. This study evaluated the usefulness of a perfusion-decellularized porcine hepatic-derived wound matrix (PDPHD-WM) in treating difficult-to-heal ulcers, or DFUs of greater than three months’ duration that had been treated with at least one other advanced method.

Methods

Over the course of 14 weeks, seven of Dr. Fridman’s patients with DFUs were treated with the PDPHD-WM. These DFUs were less than 30 days old before screening and of Wagner grade 1 or 2 with a thickness <1 cm2. These patients were at least 18 years old, had type 1 or 2 diabetes, and a glycosylated hemoglobin level of less than 12% within three months of treatment. Adequate vascular perfusion for healing was indicated by an ankle-brachial index of 0.9 or greater. All participants agreed to offloading and dressing changes, and they had previously attempted treatment with at least one other advanced treatment method, including bilayer cell-based grafts, wound matrices, dehydrated human amnion/chorion membrane scaffolds, and human amniotic membrane. Participants with signs of infection; evidence of pregnancy; sensitivity to porcine products, medication, or treatment (basic or advanced) within 30 days; lymphedema; Charcot deformity; Chopart amputation; bone cancer history; or significant improvement with SOC treatment were excluded.

Assessment and photographs were done at an initial screening visit, followed by two weeks of SOC treatment. If the patient did not show >30% improvement after this period, the DFU was fully debrided, and the PDPHD-WM was applied. The matrix was externally coated with saline gel and a compression dressing. Photography, tracing, and assessment of the DFU were done weekly for 12 weeks. The photographs were digitally scanned and calibrated for measurement.

Results

The average patient was 62.6 years old with a DFU of 25.5 months’ duration. One patient of the seven was removed because of the development of infection and osteomyelitis. Four of the remaining patients showed an early response; three of these patients had complete wound closure by 56 +/− 21 days, with the fourth patient progressing to near closure. The two remaining patients showed delayed or no response with no wound closure. The average percentage of wound closure over the 12-week treatment period was 56% +/− 63%.

Discussion and Conclusion

Previous studies have shown that treating a DFU within the first four weeks of development has a significant increase in positive outcome, as well as a decreased risk of infection and amputation. Advanced modalities, including different graft materials, have shown improved wound reduction and closure over SOC treatment. Of the seven patients treated with PDPHD-WM, three healed within the 12-week period, and all these DFUs had been present for more than two years. Although the study was conducted by one physician in his own practice, there are data to support a possible large-scale controlled study in the future.

About the Authors:
Ryan Lazar is a second-year student at Temple University School of Podiatric Medicine (TUSPM). He graduated from Florida State University in 2015 with a major in Biological Sciences, and a minor in Chemistry. He served as an "Orientation Leader" for the incoming TUSPM Class of 2021, and has planned an upcoming school-wide fundraiser for diabetes research and education alongside TUSPM's American Public Health Association student chapter. Ryan is interested in diabetic wound care, sports medicine, and limb salvage.

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.