Review: A Randomized Controlled Trial Comparing a Human Acellular Dermal Matrix Versus Conventional Care for the Treatment of Venous Leg Ulcers

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By 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: A Randomized Controlled Trial Comparing a Human Acellular Dermal Matrix Versus Conventional Care for the Treatment of Venous Leg Ulcers
Author: Cazzell S
Journal: Wounds. 2019;31(3):68-74
Reviewed by: Alexandra J. Brown, class of 2022, Temple University School of Podiatric Medicine

Introduction

Venous leg ulcers (VLUs) are common and often chronic, and these wounds diminish the quality of life and increase the financial burden for affected patients. A recent article estimated that up to 3% of the U.S. population has VLUs.1 A VLU can be severely painful and may decrease a patient’s quality of life by affecting sleep, mobility, and activities of daily living, and it can even result in social isolation.2 A 1994 paper proposed that approximately 65% of patients felt financially affected by a VLU,3 and this number is likely to have increased as a result of rising health care costs. The prevalence and chronicity of VLUs have motivated physicians to research novel techniques to heal ulcers successfully and in a timely manner.

Acellular dermal matrices have been utilized to treat diabetic foot ulcers with favorable outcomes.4 This study investigated the efficacy of a specific acellular dermal matrix for VLUs.2

Material and Methods

This investigatory study sought to compare decellularized human acellular dermal matrix (D-ADM) with conventional treatment methods for VLUs. Conventional treatment included wound therapy of “alginates, foams, or hydrogels,” with debridement of necrotic tissue by “sharp blade, scissors, or Versajet system,” followed by application of a moist or dry gauze. The current study followed a total of 28 patients for a minimum of 12 weeks, with 18 patients undergoing treatment with D-ADM (one to two applications) and 10 patients receiving conventional care as described previously. Patients received a second application of D-ADM if it was determined that the healing process had stopped, as identified by the treating physician.2


Review: Outcomes of Human Acellular Dermal Matrix Treatment of Diabetic Foot Ulcers Compared with Active Comparator or Conventional TherapyReview: Outcomes of Human Acellular Dermal Matrix Treatment of Diabetic Foot Ulcers Compared with Active Comparator or Conventional Therapy

Results

The results were organized into three groups: patients receiving one application of D-ADM, patients receiving one or two applications of D-ADM, and the control group. When isolating the data from patients receiving only one application of D-ADM, the results looked promising. However, the results were more mixed when comparing the complete D-ADM group (all applications) with the control group. The D-ADM (all applications) group had a lower percentage of wounds completely closed by 24 weeks as compared with the control group (29.4% vs. 33.3%) but a greater mean percentage reduction in wound area from baseline (59.6% vs. 8.1%). The study also compared the number of healed wounds that remained closed during the four, eight, and 12-week follow-up appointments: four in the D-ADM group and three in the control group. The data from post termination visits were not statistically significant.2

Limitations

Conventional treatment was not standardized across the control group, but rather was left to the treating physician’s discretion. It is unclear whether the control group was treated by the same physician. The multiple variables of the control group could undermine the validity of the control itself and prevent it from serving as an effective comparison with the experimental group. It was unclear whether any patients in the D-ADM group experienced complications associated with treatment.

It is also possible that the patients receiving only one application of D-ADM were more predisposed to healing than those patients requiring a second application, and this would skew data toward successful outcomes regardless of treatment utilized.

The author of the article acknowledged the small sample size of the study and the resulting inability to determine statistical significance. Finally, the author acknowledged the potential for bias because the institution had received funding from the creators of the product being investigated.

Conclusion

In conclusion, the current data are inadequate to determine whether D-ADM is superior to conventional therapy for VLU treatment. The data suggest that D-ADM may confer some benefits to VLU healing, as suggested by the higher mean percentage reduction in wound area from baseline as compared with the control group. This study has many limitations, including a lack of standard control, a small sample size, and a potential for bias. However, if patients in the D-ADM group did not experience complications, these preliminary positive outcomes will warrant further research for the use of D-ADM to treat VLUs.

References
1. Bonkemeyer Millan S, Gan R, Townsend PE. Venous ulcers: diagnosis and treatment. Am Fam Physician. 2019;100(5):298-305. doi:10.1016/0741-5214(94)90155-4
2. Cazzell S. A randomized controlled trial comparing a human acellular dermal matrix versus conventional care for the treatment of venous leg ulcers. Wounds. 2019;31(3):68-74.
3. Phillips T, Stanton B, Provan A, Lew R. A study of the impact of leg ulcers on quality of life: financial, social, and psychologic implications. J Am Acad Dermatol. 1994;31(1):49-53. doi:10.1016/S0190-9622(94)70134-2
4. Yonehiro L, Burleson G, Sauer V. Use of a new acellular dermal matrix for treatment of nonhealing wounds in the lower extremities of patients with diabetes. Wounds. 2013;25(12):340-344.

About the Authoralexandra_brown.png
Alexandra J. Brown is a second-year podiatric medical student at Temple University School of Podiatric Medicine (TUSPM) in Philadelphia, Pennsylvania. She graduated from the University of Notre Dame with a Bachelor of Science in Science-Business. Alexandra spent two years as a health care analyst specializing in clinical operations of major hospitals. Affirmed in her goal of becoming a health care provider and serving patients directly, Alexandra completed the Special Master’s Program in Physiology at Georgetown University in 2017. She has published articles in the following journals: Journal of Foot and Ankle Surgery, Foot and Ankle International, Arthroscopy: The Journal of Arthroscopic and Related Surgery, and Knee Surgery, Sports Traumatology, Arthroscopy. In the fall of 2018, she matriculated to TUSPM with a merit scholarship. She serves as the President of the American College of Foot and Ankle Surgery Club at Temple, in addition to serving as Editor and TUSPM Delegate for both the PrePodLife and Hallux Magazine websites.

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.

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

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