Antimicrobial dermal matrices to promote infection free wound closure in DTU-DFUs.

Project Summary/Abstract DFUs will affect more than 30% of diabetic patients within their lifetime and costs the US healthcare system over $20 billion annually. Many DFUs fail to heal effectively and require extensive medical intervention. Nearly 50% of DFUs worsen to “tunnel” into deep tissues involving tendons and bones (DTU-DFUs). When this happens, DFUs are susceptible to severe complications like infection, which significantly increases cost of treatment and the risk of lower limb amputation and death. The current treatment for DTU-DFUs is expensive, time consuming, complicated, and involves the sequential and cyclical application of multiple products. Antimicrobial management is always the first step in wound care, as failure to keep a wound free of infection limits healing. Despite the many antimicrobial products available, outcomes remain unsatisfactory. Gel4Med has developed G4Derm, a biosynthetic flowable wound care product designed to address complex DTU-DFUs. G4Derm has already demonstrated efficacy and safety in preclinical studies. The final product is a flowable scaffolding matrix provided as a shelf-stable, ready, and easy-to-use syringe with an applicator tip. The flowable form factor allows G4Derm to completely fill cavities of complex tunneling wounds. Once applied, the hydrogel resolves into a scaffolding matrix with mammalian cell attachment sites to facility tissue regeneration. The patented composition of G4Derm is uniquely and inherently antimicrobial – the gel disrupts bacterial membranes on contact. In combination, these characteristics make G4Derm a highly useful product to address the dire unmet need of DTU-DFUs. The goal of this proposal is to evaluate the clinical efficacy, safety, and feasibility of G4Derm in an early-phase, pilot clinical study for patients with refractory DTU-DFUs. This clinical evaluation is key to making G4Derm available to patients with DTU wounds. Gel4Med will collect data on wound healing, tissue regeneration, quality of life, and risk of infection. After the treatment period, patients will be able to participate in a 6-month follow-up period to assess the risk of recurrence and durability of wound closure. The completion of this pilot clinical study is a key step to bringing G4Derm, which combines enhanced wound healing with microbial management, to patients with treatment- resistant DTU-DFUs and represents a paradigm shift in the treatment complex chronic wounds.