A Qualitative Analysis of Advanced Biologic Products in Diabetic Foot Wounds: A Single Institution Study

BACKGROUND: As management of complicated wounds secondary to diabetes mellitus (DM) and other chronic comorbidities become more laborious in presenting patients, biologically engineered tissue products have shown great promise in augmenting healing and faster return-to-normal function in soft tissue reinforcement and regenerative soft tissue repair.“1” While adjunctive use of biologics have proven to provide considerable benefits in reconstruction, there are significant associated product costs. PURPOSE: To compare outcomes of chronic diabetic wounds adjunctively treated with a biologic product with goals to develop effective treatment algorithms and policies for using biologics to provide the most benefit to patients while promoting hospital resource efficiency. METHODS AND MATERIALS: A single-institutional retrospective chart review from 2016 to 2021 evaluated 155 diabetic patients adjunctively treated with a biologic product during reconstruction. Biologics include porcine urinary bladder matrix (pUBM), bovine collagen (BC), amniotic membrane/tissue (AM/T), acellular dermal matrix (ADM), and porcine dermis (PD). Patients were classified by having an open lower extremity wound(s) with or without DM. Patient demographics and medical history were collected. Evaluated outcomes included lower extremity amputation, osteomyelitis, and mortality stratified by specific biologic product implemented in patient care. Categorical variables were analyzed using Pearson chi-square and Fisher exact test. Binomial logistic regression and Akaike Information Criterion analysis (AIC) assessed potential impacts biologics may have on patient outcomes in addition to determining the regression model with the best fit for the quality of data. RESULTS: Mean follow-up was 3.5 years. Sixty-two percent were male and 38% were female. Seventy-nine percent were Caucasian, 19% African-American, 1% Native American/Alaska Native, and <1% Native Hawaiian or Pacific Islander. Mean age was 60.1 years. Thirty-four percent of patients had chronic history of DM. Forty-three percent of patients experienced ulcer recurrence. Sixty-two percent of patients received pUBM. The remaining 37% were treated with higher-costing biologics.”2” Thirty-eight percent of patients had history of osteomyelitis with 17% recurrence rate. Twenty-three percent of patients suffered amputation. Of amputees, 51% were diabetic. Thirty percent of patients were assessed per Wagner’s classification. Charlson Comorbidity Indexes were 11% low-risk, 21% mild-risk, 25% moderate-risk, and 44% severe-risk. Overall mortality was 15%, with 23% and 12% being with and without DM, respectively. In the cohort that received treatment with pUBM, patients with DM experienced higher amputation rates compared to patients without DM (p =.0035). There were no significant differences found in outcomes for both groups overall in mortality and osteomyelitis with use of any specific biologic product. CONCLUSION: To our knowledge, there is no published evidence to-date reporting associated outcomes of low/high-cost biologics in managing lower extremity DM wounds. Further investigation is warranted to better delineate and understand cost-benefit ratios of outcomes in this specific patient population. References: 1. Johnson RM, Harrison LM, Anderson SR. The Adjunctive Use of Biologically Engineered Products in Plastic Surgery Practice. J Am Coll Clin Wound Spec. 2018;8(1-3):4-9. Published 2018 Jan 31. doi:10.1016/j.jccw.2018.01.002 2. Martinson M, Martinson N. A comparative analysis of skin substitutes used in the management of diabetic foot ulcers. J Wound Care. 2016;25(Sup10):S8-S17. doi:10.12968/jowc.2016.25.Sup10.S8