STTR Phase I Development of Novel Antibacterial and Antifungal Bioadhesive Biomaterials for Diabetic Skin Wound Healing

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Abstract Diabetic ulcers or pressure ulcers are common for patients with diabetes, spinal cord injuries, etc. Without proper management, such wounds often lead to infections such as osteomyelitis or sepsis, resulting in high mortality and morbidity. In addition to bacterial infection, diabetic patients are also more susceptible to cutaneous fungal infections. Advanced wound dressings and advanced wound therapies should be employed as the severity of infection occurs in diabetic ulcer or even pressure ulcer. This project aims to develop novel collagen-citrate-based polymer biomaterial medical devices which may find applications in skin wound healing, especially in challenging diabetic skin wound healing. Our biomaterial medical devices are potentially unique in terms of dual degradation mechanism (enzymatic and hydrolysis), better reproducibility than biological allografts, sustainable anti-fungal drug released as a degradation product, sutureless wound closure due to strong tissue adhesion, and excellent biocompatibility, etc. It is built upon PSU’s patented citrate- based polymer adhesive and DET’s unique collagen electrochemical deposition process. In Aim 1, crosslinked collagen-citrate-based polymer of at least 5 different compositions will be prepared. The resultant collagen-citrate polymer biomaterials will be characterized and screened for antimicrobial properties, tissue adhesive properties, cell biocompatibility, in-vitro degradability (Collagenase degradation assay and hydrolysis), and mechanical properties. One leading collagen-citrate based polymer wound matrix will be determined. In aim 2, Proposed leading collagen-citrate based polymer matrix will be tested in a diabetic polymicrobial infected skin wound model compared to an FDA-approved collagen wound matrix and other controls. We expect that proposed novel collagen-citrate polymer matrix may significantly accelerate the healing of infected diabetic skin wounds compared to controls. The success of this Phase-I STTR may lead to a collagen-citrate based polymer matrix positioned for a Phase II study, which will lead to an advanced wound therapy for reduce the health burden of diabetic skin wounds and even regular skin wounds.