Chronic wounds such as diabetic foot ulcers (DFU) represent a major area of medical concern. Of the approximately 23 million diabetic patients in the USA, almost 15% (~3.4 million) display these types of partial thickness wounds. More than 80,000 diabetes related lower extremity amputations (LEAs) are conducted annually in the USA alone. Fully eighty-five percent of LEAs in diabetic patients are preceded by biofilm phenotype infections in foot ulceration. It is recently being recognized that an added primary impediment to the healing of DFU is such biofilm phenotype infections. DFU entrenched biofilms consist of polymicrobial populations of cells encased in hydrated extracellular polymeric substances that are tightly attached to the wound surface. The biofilm phenotype imparts considerable resilience to these infections and current modalities including surgical debridement, topical and systemic antimicrobials, topical biocides and topical anti- biofilm agents have major limitations in effectively killing resident bacteria and more clinically importantly, completely removing biofilm from the wound bed. Traditional wound management modalities such as grafts, advanced bioengineered dressings and negative pressure wound therapy cannot be applied with any expectation of success without first extensively debriding the wound. Lynntech, Inc. in collaboration with Texas Tech University Health Sciences Center and in consultation with the Southwest Regional Wound Care Center proposes to develop an innovative, inexpensive and compact chronic wound management device, termed SNAPCAP, which has the potential to be applied to bioburdened chronic wounds to overcome the limitations of existing modalities. This device will be engineered to rapidly and reagentlessly remove biofilm from the wound bed without relying on surgical debridement and to subsequently apply a follow on therapy that has the potential to improve the healing of debrided chronic wounds. During this Phase I SBIR effort, our specific Aims are to (1) design and fabricate prototype SNAPCAP devices, (2) optimize SNAPCAP performance for biofilm removal and epithelial gap reduction in vitro using a human skin equivalent tissue model of infected wound healing and (3) preliminarily evaluate the utility of SNAPCAP in vivo using a murine model of splinted full- thickness polymicrobial biofilm infected diabetic wound healing. The successful completion of these specific Aims should demonstrate ample feasibility of this innovative new chronic wound management approach, and will allow us to plan more comprehensive technology development and commercialization thrusts in a future follow-on Phase II effort. The eventual commercial availability of SNAPCAP devices is likely to sustain high positive impact for the patient populace suffering from chronic wounds that are bioburdened, in particular, polymicrobial biofilm infected DFU.
The potential long-term impact of this SBIR effort is a new paradigm in the clinical management of chronic wounds such as polymicrobial biofilm infected DFU. Our envisioned automated SNAPCAP wound treatment devices may provide significant clinical benefit for the millions of diabetic patients suffering from bio-burdened DFU. This approach may have the potential to greatly improve the quality of life of patients suffering from DFU, while simultaneously lowering the costs, pain and risks associated with routine maintenance debridement procedures.