(CR-017) Real-World Outcomes of Fetal Bovine Dermis in Diabetic Foot Ulcer Management

Malachy Asuku, MD, MBA; Maria Leonard, BSN, RN; Yi Arnold, PhD, MBA; Angela Siebeneck, BSN, MHA, MBA; Paula Searcy, MBA

Introduction: Diabetic foot ulcers (DFUs) are among the most challenging chronic wounds, often complicated by impaired vascularity and high infection risk. Advanced biologic scaffolds, such as fetal bovine dermis (FBD), provide structural integrity and support tissue regeneration. A prior randomized controlled trial (RCT) demonstrated significantly higher closure rates with FBD compared to standard of care (59.5% vs 35.4% at 12 weeks), confirming its clinical benefit.¹ However, current real-world evidence from multinational practice remains limited. This study assessed real-world outcomes of FBD in DFU management across US and EU clinical practices.

Methods: A retrospective chart review was conducted via a HIPAA-compliant digital platform for secure data collection. Clinicians submitted de-identified cases treated with FBD between June 2022 and June 2025 (up to 20 cases per contributor). Structured forms captured wound type, closure status, time to closure, and adverse events. The study was exempt from IRB and consent requirements due to its retrospective, anonymized design. Descriptive analysis focused exclusively on DFU cases.

Results:

A total of 123 DFU cases were collected and analyzed. Complete wound closure at 12 weeks was achieved in 77.2% of cases (95/123). Safety outcomes were favorable: no intraoperative device-related adverse events were reported. Infection complications occurred in 3.3% of cases, and wound recurrence was noted in 6.5%, primarily within six months.

Discussion: This chart review highlights consistent real-world performance of FBD in DFU management across US and EU practices. Real-world DFU outcomes confirm the clinical benefits of FBD observed in controlled trials. Outcomes observed in routine care align closely with those reported in controlled trials, supporting the clinical benefits of FBD beyond the constraints of RCT settings. Compared to prior RCT data¹, this study demonstrates comparable effectiveness in the real-world setting, achieving high closure rates with minimal complications. Low infection incidence (3.3%) and modest recurrence (6.5%) suggest durable healing and potential to reduce downstream risks such as hospitalization and amputation. While retrospective design and variable follow-up are limitations, these findings reinforce FBD as a reliable, versatile option for complex diabetic wounds and underscore its potential role in cost-effective, multidisciplinary limb-preservation strategies.