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

Introduction:  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 wounds1. 

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 suturing1.  In addition, the upper layer supports growth factor binding and preservation, and provides a scaffold for migrating keratinocytes2. 

The lower layer consists of a thick porous matrix, capable of absorbing wound exudate1, and modulates matrix metalloproteinase (MMP) activity, thus providing the optimal structure for cell migration and attachment2.  Recently positive clinical outcomes when using PRBM to treat patients with hard to heal diabetic foot ulcers were published3. 

Methods: 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 or two, persisting for longer than 4 weeks, received up to 12 weekly applications of the PRBM as part of a standard wound care regimen at a single outpatient center. 

Results: In the overall population, the mean presence of index ulcers was 12 weeks with the average wound area of 2.4 cm2 .  Complete wound closure was achieved for 90% of the ten wounds within 12 weeks.  Mean time to heal was 6.1 weeks.  Percentage area reduction was 85% at 6 weeks and 94% at 12 weeks.  4 of 5 shallow ulcers with depths from 0.1 cm to 0.2 cm healed within 4.8 weeks, while all 5 deeper ulcers with depth from 0.4 cm to 1.6 cm healed within 7.2 weeks.  In this patient series, there were no product related adverse events noted. 

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