A Retrospective Case Series to Evaluate the Safety and Efficacy of a Novel Advanced Wound Care Matrix in the Management of Non Healing Diabetic Foot Ulcers

Background: Advanced Tissue Matrices have shown promise for treating diabetic wounds and other soft tissue defects. Recent advancements in technology have led to the introduction of a novel porcine graft that features a bilayer structure and is specifically designed for the management of chronic wounds. The upper dense compact layer protects the wound and the healing process and facilitates reepithelization. This structure has a smooth texture with significant pull out strength properties to allow suturing. The lower layer consists of a thick, porous spongeous scaffold that provides a favorable environment for cell migration.  

Purpose: The purpose of this case series was to report the efficacy and safety of this novel graft in treating diabetic foot ulcers.

Methods: Ten consecutive patients with non healing diabetic foot ulcers greater then 4 weeks, Wagner one and two received weekly application of the bilayered graft along with standard wound care at one wound center. These wounds were evaluated at weekly intervals for up to 12 weeks. After submission to the central IRB for approval, the patients returned for informed consent to be obtained. The primary endpoint was complete wound closure at 12 weeks. The average wound size was 3.3cm².

Results: At study conclusion, complete wound closure was achieved for 90% of the wounds 9/10. The average time to complete wound closure was 2.7 weeks. There were no serious adverse events related to the graft treatment group.

Conclusion: In conclusion, this case series suggests that this unique porcine graft may be an effective and safe method for treatment of diabetic foot ulcers.  Larger pivotal studies are underway to confirm or refute these initially promising findings.