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

Introduction: 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 advanced wound matrix 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. This upper structure has a smooth texture with significant pull-out strength properties to allow suturing. It supports growth factor binding and preservation and also provides a scaffold for migrating keratinocytes. The lower layer consists of a thick porous layer, which is able to absorb wound fluid. It modulates matrix metalloproteinase activity and provides optimal structure for cell migration and attachment.

Method: The purpose of this case series was to report the efficacy and safety of this novel graft in treating diabetic foot ulcers. Ten consecutive patients with nonhealing diabetic foot ulcers persisting longer than four weeks, Wagner one and two, received weekly application of the bilayer matrix along with standard wound care at a single 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 to obtain informed consent. The primary endpoint was complete wound closure at 12 weeks. The average wound size was 3.3 cm². At study conclusion, complete wound closure was achieved for 90% of the wounds, with 9/10 moving on to full closure. 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, bilayer advanced wound matrix 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.