Annually, 5 to 7 million Americans are treated for chronic wounds that arise from diabetes, lower extremity arterial disease, lower extremity venous disease, pressure ulcers, and traumatic injuries, including burns, demonstrating the need for new advanced technologies for treatment. Advanced Plasma Products will build upon its successful Phase I results and advance the development of the Atmospheric Plasma Wound Applicator (APWA) prototypes that inactivate biofilm without causing damage to surrounding tissues, thereby healing the wound. The prototype will be tested for its wound disinfecting capabilities with in vitro wound biofilm models of different clinically significant strains and polymicrobial biofilm. Penetration studies will be performed to evaluate the depth of plasma active species in tissue and mechanistic studies will evaluate the mechanism of inactivation of microbial cells by plasma treatment. We will demonstrate the therapeutic potential of atmospheric plasma to improve wound healing by the removal of microorganisms from the biofilm of splinted excisional wounds of normal and diabetic mice and the introduction of various gaseous nitrogen species. A second generation prototype will be built and tested in a clinical setting with equine lower limb wounds. Following this two year effort, APP will initiate FDA 510K regulatory approval process.
Public Health Impact Statement Chronic wounds affect 5 to 7 million Americans annually and generate healthcare cost in the billions of dollars. More importantly, chronic wounds contribute significantly to the mortality of patients in the United States, and lead to over 80,000 amputations annually due to complications in diabetic and peripheral arterial disease patients. Most chronic wounds are treated by outpatients wound care center requiring weekly visits and can take months to years to heal at high costs. The health-related quality of life of patients suffering from chronic wounds is similar to that of patients wih recurrent cancer. There is an increase in lack of mobility and patients feel isolated and the incidence of depression is significantly higher than the general population. Since many chronic wound patients are 65 years of age or older and covered by Medicare or Medicaid, there is a push to look at lower-cost alternative treatment technologies. Building upon our expertise in disinfection/sterilization of sensitive items, APP is meeting this demand to effectively treat chronic wounds by developing an Atmospheric Plasma Applicator using its patented atmospheric plasma technology.