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

抗菌真皮基质可促进 DTU-DFU 中无感染伤口闭合。

• 批准号: 10766085
• 负责人: Manav Mehta
• 金额: $ 112万
• 依托单位: GEL4MED, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10766085
• 关键词: Address; Adoption; Affect; Aftercare; Amputation; Animals; Bacteria; Biodegradation; Biological; Cell-Matrix Junction; Cessation of life; Characteristics; Clinical; Clinical Research; Clinical Trials; Complex; Consumption; Cyclic GMP; Data; Data Analyses; Data Collection; Dermal; Diabetic Foot Ulcer; Economic Burden; Effectiveness; Elements; Endotoxins; Environment; Evaluation; Face; Failure; Funding; Gel; Goals; Granulation Tissue; Growth; Healthcare Systems; Human; Hydration status; Hydrogels; Infection; Institutional Review Boards; Intervention; Legal patent; Life; Lower Extremity; Mammalian Cell; Medical; Membrane; Methodology; Microbial Biofilms; Microbiology; Morbidity - disease rate; Osteomyelitis; Outcome; Patients; Peptide Hydrolases; Peptides; Performance; Phase; Positioning Attribute; Preclinical Testing; Predisposition; Preparation; Price; Privatization; Process; Production; Property; Quality of life; Recurrence; Refractory; Resistance; Risk; Risk Assessment; Running; Safety; Secure; Site; Skin Substitutes; Sterility; Sterilization; Surface; Syringes; Tendon structure; Testing; Thick; Time; Tissue Banks; Tissues; Treatment Cost; Ulcer; United States National Institutes of Health; Validation; Work; antimicrobial; biomaterial compatibility; bone; chronic wound; clinic ready; clinical efficacy; clinical practice; clinical research site; clinical trial readiness; clinically relevant; commercialization; cost; design; diabetic; diabetic patient; early onset; efficacy testing; experience; fabrication; first-in-human; follow-up; fungus; healing; infection risk; limb amputation; manufacture; microbial; mortality; multi-drug resistant pathogen; nanofiber; novel; performance tests; point of care; porcine model; pre-clinical; preclinical safety; preclinical study; randomized, clinical trials; research and development; research clinical testing; restoration; scaffold; self assembly; skin barrier; socioeconomics; statistics; study population; tissue regeneration; tissue repair; treatment duration; wound; wound care; wound closure; wound healing

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.

项目总结/摘要 DFU将在其一生中影响超过30%的糖尿病患者， 每年超过200亿美元的医疗保健系统。许多DFU无法有效愈合，需要 广泛的医疗干预。近50%的DFU恶化为“隧道”进入深部组织 涉及肌腱和骨骼（DTU-DFU）。当这种情况发生时，DFU容易受到严重的 并发症，如感染，这大大增加了治疗费用和降低风险， 截肢和死亡 目前对DTU-DFU的治疗昂贵、耗时、复杂， 涉及多种产品的顺序和周期性应用。抗菌管理 是伤口护理的第一步，因为不能保持伤口不受感染会限制愈合。 尽管有许多抗菌产品，但结果仍然不令人满意。 Gel 4 Med开发了G4 Derm，一种生物合成的可流动伤口护理产品， 以处理复杂的DTU-DFU。G4 Derm已经证明了其在以下方面的有效性和安全性： 临床前研究。最终产品是可流动的支架基质， 准备就绪，易于使用的注射器与一个点药器尖端。可流动的外形尺寸允许G4 Derm 来完全填充复杂隧道伤口的空洞一旦应用，水凝胶分解成 具有哺乳动物细胞附着位点以促进组织再生的支架基质。的 G4 Derm的专利成分具有独特的内在抗菌性-凝胶破坏了 细菌膜接触。结合起来，这些特性使G4 Derm成为一种高度 有用的产品，以解决迫切未满足的需求DTU-DFU。 本提案的目的是评估以下药物的临床疗效、安全性和可行性： G4 Derm用于难治性DTU-DFU患者的早期初步临床研究。这 临床评价是使G4 Derm可用于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。后 在治疗期间，患者将能够参加6个月的随访期，以评估 复发的风险和伤口闭合的持久性。 这项试点临床研究的完成是G4 Derm的关键一步， 将增强伤口愈合与微生物管理相结合，对患者进行治疗- 耐DTU-DFU，代表了治疗复杂慢性伤口的范式转变。