Use of a Purified Reconstituted Bilayer Matrix for the Treatment of Chronic Diabetic Foot Ulcers: A Retrospective Case Series

Diabetic foot ulcers (DFU) present an enormous challenge to healthcare providers and systems throughout the world.  While many advanced tissue matrices have demonstrated promise in treating chronic DFUs, recent technological advancements have led to the development of a Purified Reconstituted Bilayer Matrix (PRBM).  PRBM features a bilayer structure, specifically designed for the management of chronic wounds (1).  An upper dense compact layer protects the wound throughout the healing process and has a smooth texture with significant pull out strength properties that allows for suturing (1).  In addition, the upper layer supports growth factor binding and preservation, and provides a scaffold for migrating keratinocytes (2).  The lower layer consists of a thick porous matrix, capable of absorbing wound exudate (1), and modulates matrix metalloproteinase (MMP) activity, thus providing the optimal structure for cell migration and attachment (2). Recently positive clinical outcomes when using PRBM to treat patients with hard to heal diabetic foot ulcers were published (3).

The purpose of this case series was to evaluate the efficacy and safety of this novel matrix in the treatment of chronic DFUs. Ten consecutive patients with non-healing DFUs, Wagner grade one, persisting for longer than 4 weeks, received weekly application of the PRBM as part of a standard wound care regimen at a single outpatient center. 

Complete wound closure was achieved for 90% of the wounds, with 9/10 progressing to full closure within 12 weeks. There were no product related adverse events noted in this patient series. 

In conclusion, this case series suggests that the unique, bilayer PRBM may be an effective treatment modality for chronic DFUs.  Larger studies are underway to investigate these findings further.

Trademarked Items (if applicable):

References (if applicable): 1. Instructions for use, Geistlich Derma-Gide®. Geistlich Pharma AG, Wolhusen, Switzerland
2. Armstrong et al. Functional Properties of a Purified Reconstituted Bilayer Matrix Design Support Natural Wound Healing Activities. In preparation.
3. Armstrong et al. An observational pilot study using a purified reconstituted bilayer matrix to treat non-healing diabetic foot ulcers. Int Wound J. 2020 Aug;17(4):966-973.