ABSTRACT
BACKGROUND: Autologous platelet-rich plasma products can significantly vary with respect to platelet concentration, the presence of additional cellularity, and the use of additives. Therefore, the utility of each formulation for treating chronic wounds needs to be established.
OBJECTIVE: To establish the efficacy of up to 12 weeks of treatment with Aurix hematogel for healing diabetic foot ulcers against usual and customary care including any wound modality in 129 patients using a Medicare Coverage with Evidence Development paradigm.
METHODS: This pragmatic randomized controlled trial was conducted in 28 real-world outpatient wound care sites using an inclusive design that included participants with various health risks, comorbidities (eg, peripheral arterial disease, smoking), and any wound severity (Wagner 1-4).
RESULTS: Kaplan-Meier analysis showed a significant (log-rank P = .0476) time-to-heal advantage, with 48.5% of wounds healing with Aurix hematogel compared with 30.2% with usual and customary care. A higher percentage of healing was observed for Aurix across all wound severities (Wagner grade 1-4). Subgroup analysis revealed a significant healing advantage for Aurix when treating wounds accompanied by peripheral arterial disease and a demonstrated advantage for smokers.
CONCLUSIONS: This first Coverage with Evidence Development study in wound care demonstrates the effectiveness of Aurix for treating diabetic foot ulcers in Medicare beneficiaries.