(CS-103) A Pilot Study of Borate Glass Synthetic Graft with Autologous Platelet-Rich Fibrin As a Wound Healing Model

Introduction: Chronic lower extremity wounds represent a significant clinical challenge, with healing often impaired by dysfunctional extracellular matrix formation, inadequate angiogenesis, and prolonged inflammation. Borate-based bioactive glass fiber matrices have demonstrated superior healing rates in diabetic foot ulcers through controlled release of therapeutic ions and three-dimensional scaffolding that mimics native fibrin architecture, while autologous platelet-rich fibrin delivers concentrated growth factors that enhance endothelial proliferation, angiogenesis, and tissue remodeling. This pilot proof-of-concept study evaluates a novel therapy utilizing borate-based synthetic tissue allograft with autologous platelet-rich fibrin for complex lower extremity wounds.

Methods: Five patients with chronic lower extremity wounds of diverse etiologies—including venous, diabetic, post-surgical, traumatic, and atypical wound types—were treated with combined borate-based bioactive glass fiber matrix and autologous platelet-rich fibrin weekly for 4 weeks as a trial pilot study of a new woundh healing model.Venous blood was harvested via standard phlebotomy technique and processed using the PurePRP GS-30 Pure II system to obtain platelet-rich plasma through controlled centrifugation, which concentrates platelets and growth factors while maintaining platelet viability and function. The standardized preparation protocol ensures reproducible platelet concentration and growth factor content, addressing the critical need for consistency in autologous biologic therapies.  The borate-based scaffold provides biocompatible, biodegradable three-dimensional architecture with controlled release of calcium and borate ions to stimulate healing cascades, while platelet-rich fibrin functions as an autologous delivery system for vascular endothelial growth factor, platelet-derived growth factor, and other bioactive molecules that promote angiogenesis and cellular proliferation.  Dressings included non-adherent primary dressing and polyurethane foam and secured with roll gauze.

Results: 5 prototype-treated wounds showed significant closure rates of greater than 55% after 4 weeks of trial therapy.  There were no adverse reactions or adverse side effects from the therapy provided.  These results show a reasonable expectation based on PRP literature showing progressive healing over 8-12 week periods. The median time to complete closure in PRP-treated chronic ulcers ranges from 6-8 weeks, suggesting that 4-week outcomes represent mid-treatment progress appropriate to the literature.

Discussion: This pilot study establishes preliminary safety and feasibility data for a novel regenerative medicine approach that combines synthetic bioactive materials with autologous biologics, potentially offering an advanced treatment option for challenging lower extremity wounds across multiple etiologies.  The synergistic application of structural scaffolding with autologous growth factor delivery represents a rational approach to complex wound management, particularly for wounds refractory to standard therapies.