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

项目摘要/摘要 DFU将在一生中影响超过30%的糖尿病患者，并在美国造成损失 医疗保健系统每年超过200亿美元。许多DFU无法有效治愈，需要 广泛的医疗干预。近50%的DFU恶化到深部组织 累及肌腱和骨骼(DTU-DFU)。当这种情况发生时，DFU容易患上严重的 感染等并发症，这显著增加了治疗成本，降低了 截肢和死亡。 目前DTU-DFU的治疗昂贵、耗时、复杂、 涉及多种产品的顺序和循环应用。抗菌药物管理 总是伤口护理的第一步，因为不能保持伤口不受感染限制了愈合。 尽管有许多抗菌产品可用，但结果仍然不令人满意。 Gel4Med开发了G4Derm，这是一种生物合成的可流动伤口护理产品，旨在 以解决复杂的DTU-DFU。G4Derm已经证明了在 临床前研究。最终产品是作为货架稳定器提供的可流动脚手架基质， 准备好的，易于使用的注射器和喷头。可流动的外形系数允许G4Derm 以完全填充复杂隧道伤口的空洞。一旦涂上，水凝胶就会分解成 一种具有哺乳动物细胞附着位置的支架基质，以促进组织再生。这个 G4Derm的专利成分具有独特的内在抗菌作用--凝胶可以破坏 接触的细菌膜。这些特征结合在一起，使G4derm成为一种高度 解决DTU-DFU迫切需求的有用产品。 这项建议的目标是评估临床疗效、安全性和可行性。 G4Derm用于难治性DTU-DFUS患者的早期试点临床研究。这 临床评估是将G4derm提供给DTU伤口患者的关键。Gel4Med 将收集有关伤口愈合、组织再生、生活质量和感染风险的数据。之后 在治疗期间，患者将能够参与为期6个月的随访期进行评估 伤口闭合的复发风险和耐久性。 这项先导性临床研究的完成是带来G4Derm的关键一步，G4Derm 将促进伤口愈合与微生物管理相结合，为患者提供治疗- 耐药DTU-DFUS代表着治疗复杂慢性伤口的范式转变。

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.