Phase I Amount
$1,119,996
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.
Public Health Relevance Statement: Project Narrative Deep tissue and tunneling diabetic foot ulcers (DTU-DFUs) are extremely difficult to treat with current wound care products, often becoming infected and putting patients at risk of lower limb amputation and death. To address this unmet clinical need, Gel4Med has designed G4Derm, a sterile, biosynthetic flowable matrix that uniquely combines tissue regeneration with microbial management. G4Derm has demonstrated efficacy and safety in preclinical studies and herein Gel4Med proposes a first-in-human clinical study to test the efficacy, safety, and feasibility of G4Derm in patients with DTU-DFUs; this study marks a significant advancement in the commercialization of G4Derm and has the potential to change clinical practice in the management of complex wounds.
Project Terms: Adoption; Affect; After Care; After-Treatment; post treatment; Aftercare; Amputation; Animals; Bacteria; Biodegradation; bone; Clinical Research; Clinical Study; Clinical Trials; Data Analyses; Data Analysis; data interpretation; Data Collection; Cessation of life; Death; Elements; Endotoxins; Environment; Face; faces; facial; fungus; Gel; Goals; Granulation Tissue; Growth; Generalized Growth; Tissue Growth; ontogeny; Cyclic GMP; Guanosine Cyclic Monophosphate; cGMP; Healthcare Systems; Health Care Systems; Human; Modern Man; Infection; Lower Extremity; Lower Limb; Membrum inferius; Methodology; Microbiology; Morbidity - disease rate; Morbidity; mortality; United States National Institutes of Health; NIH; National Institutes of Health; Osteomyelitis; Bone Infection; Legal patent; Patents; Patients; Peptide Hydrolases; Esteroproteases; Peptidases; Protease Gene; Proteases; Proteinases; Proteolytic Enzymes; Peptides; Privatization; Production; Quality of life; QOL; Recurrence; Recurrent; research and development; Development and Research; R & D; R&D; Risk; Running; Safety; statistics; Syringes; Tendon structure; Tendons; Testing; Time; Tissue Banks; Tissue Collection; Tissue repository; Tissues; Body Tissues; Ulcer; Ulceration; Work; wound healing; Wound Repair; wound resolution; Price; pricing; Microbial Biofilms; biofilm; Risk Assessment; Treatment Cost; Site; Surface; Clinical; Refractory; Phase; biologic; Biological; Medical; randomized, clinical trials; Evaluation; Susceptibility; Predisposition; Dermal; Failure; diabetic; Funding; scaffold; scaffolding; Life; Complex; treatment duration; Treatment Period; treatment days; restoration; biomaterial compatibility; biocompatibility; experience; Membrane; membrane structure; Performance; microbial; Hydrogels; Sterility; sterile; novel; Positioning Attribute; Position; performance tests; Property; Intervention; Intervention Strategies; interventional strategy; Cell-Matrix Junction; Cell Attachment; Cell-Matrix Adhesions; Skin Substitutes; Thickness; Thick; Effectiveness; Hydration; Hydration status; Address; Diabetic Foot Ulcer; diabetic foot wound; Data; Economic Burden; Mammalian Cell; Preclinical Testing; pre-clinical testing; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Validation; validations; Preparation; preparations; Characteristics; Process; follow-up; Active Follow-up; active followup; follow up; followed up; followup; socioeconomics; socio-economic; socio-economically; socioeconomically; point of care; tissue regeneration; regenerate new tissue; regenerate tissue; regenerating damaged tissue; regenerating tissue; tissue regrowth; tissue renewal; tissue specific regeneration; pre-clinical; preclinical; preclinical study; pre-clinical study; early onset; self assembly; cost; healing; designing; design; clinical efficacy; nano fiber; nanofibrous; nanofiber; clinical site; clinical research site; Outcome; tissue wound; wounding; wounds; wound; Consumption; resistant; Resistance; anti-microbial; antimicrobial; clinical relevance; clinically relevant; commercialization; diabetic patient; pre-clinical safety; preclinical safety; clinical practice; efficacy testing; Sterilization; Secure; IRB; IRBs; Institutional Review Boards; tissue repair; amputated limb; limb amputation; MDR organism; MDR pathogen; multi-drug resistant organism; multidrug resistant organism; multidrug resistant pathogen; multiple drug resistant organism; multiple drug resistant pathogen; multi-drug resistant pathogen; chronic skin wound; chronic wound; cutaneous barrier; dermal barrier; epidermal barrier; skin barrier; study population; wound closure; first in man; first-in-human; infection risk; wound assessment; wound monitoring; wound care; clinical trial readiness; pig model; piglet model; swine model; porcine model; manufacture; fabrication; clinic ready; clinical ready
