SBIR-STTR Award

Annually, 5 to 7 million Americans are treated for chronic wounds that arise from diabetes, lower extremity arterial disease, lower extremity venous disease and edema, and pressure ulcers, and traumatic injuries, including burns. There is a real need for new advanced technologies to treat chronic wounds since a significant number of these wounds do not heal after a year of treatment with current technologies. This application proposes to develop an Atmospheric Plasma Applicator for treatment of chronic wounds. Advanced Plasma Products, Inc (APP) will build upon its expertise in atmospheric plasma to engineer a laboratory benchtop prototype that is capable of inactivating microorganisms, including, biofilm without causing damage to surrounding tissues. The prototype will then be tested for its wound disinfecting capabilities with two in vitro wound biofilm models: the Colony-Drip Flow Reactor (DFR) model and the modified Keratinocyte Scratch Assay co-cultured with biofilm. A chronic wound animal model will then be used to investigate efficacy of the Atmospheric Plasma Applicator and tissue damage after plasma treatment. This work will provide the basis to submit a Phase II proposal in which a first generation prototype will be built and tested to meet FDA regulatory approval.

Public Health Relevance:
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 with 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.

Thesaurus Terms:
Acute;Affect;Age-Years;American;Amputation;Animal Model;Animal Models And Related Studies;Apoplexy;Area;Assay;Bacteria Resistance;Bacteria Resistant;Bacterial Infections;Bacterial Resistant;Bed Sores;Bedsore;Bioassay;Biologic Assays;Biological Assay;Blood Plasma;Body Tissues;Brain Vascular Accident;Burn Injury;Burns;Cardiac Infarction;Caring;Cell Communication;Cell Interaction;Cell Locomotion;Cell Migration;Cell Movement;Cell-To-Cell Interaction;Cells;Cellular Migration;Cellular Motility;Cerebral Stroke;Cerebrovascular Apoplexy;Cerebrovascular Stroke;Chemicals;Chronic;Co-Culture;Cocultivation;Coculture;Coculture Techniques;Collaborations;Cutaneous Disorder;Decubitus Ulcer;Dermatoses;Development;Device Approval;Device Approval Process;Diabetes Mellitus;Disease;Disinfection;Disorder;Dose;Dropsy;Edema;Engineering;Environment;Fibroblasts;Gases;General Population;General Public;Generations;Goals;Healed;Health Care Costs;Health Costs;Health Insurance For Aged And Disabled, Title 18;Health Insurance For Disabled Title 18;Healthcare Costs;Histopathology;Human;Hydrops;In Vitro;Incidence;Injury;Investigation;Killings;Laboratories;Lead;Legal Patent;Life;Lower Extremity;Lower Limb;Man (Taxonomy);Medicaid;Medical Device;Medicare;Membrum Inferius;Mental Depression;Methods;Mice;Mice Mammals;Microbial Biofilms;Microscopy;Modeling;Modern Man;Montana;Mortality;Mortality Vital Statistics;Motility;Murine;Mus;Myocardial Infarct;Myocardial Infarction;Operative Procedures;Operative Surgical Procedures;Otomy;Out-Patients;Outpatients;P. Aeruginosa;P.Aeruginosa;Patents;Patients;Pb Element;Performance;Peripheral Arterial Disease;Phase;Plasma;Plasma Serum;Pressure Sore;Pressure Ulcer;Pseudomonas Aeruginosa;Pseudomonas Pyocyanea;Public Health;Punch Biopsy;Recurrent Cancer;Recurrent Malignant Neoplasm;Recurrent Malignant Tumor;Research Specimen;Reticuloendothelial System, Serum, Plasma;Risk;S. Aureus;S.Aureus;Safety;Skin Diseases;Skin Diseases And Manifestations;Specimen;Staining Method;Stainings;Stains;Staphylococcus Aureus;Sterilization;Surgical;Surgical Interventions;Surgical Procedure;Surgical Incisions;Technology;Temperature;Testing;Time;Tissues;Title 18;Toxic Effect;Toxicities;United States;Universities;Venous;Visit;Work;Wound Healing;Wound Repair;Alternative Treatment;Animal Tissue;Bacterial Disease;Bacterial Resistance;Base;Biofilm;Brain Attack;Cardiac Infarct;Catalyst;Cell Motility;Cerebral Vascular Accident;Cerebrovascular Accident;Coronary Attack;Coronary Infarct;Coronary Infarction;Cost;Depression;Design;Designing;Developmental;Diabetes;Diabetic;Disease/Disorder;Exhaust;Fruits And Vegetables;Hazard;Healing;Health Insurance For Disabled;Health Related Quality Of Life;Heart Attack;Heart Infarct;Heart Infarction;Heavy Metal Pb;Heavy Metal Lead;In Vivo;Incision;Keratinocyte;Meetings;Microbial;Microorganism;Model Organism;New Technology;Novel Technologies;Peripheral Artery Disease;Product Development;Prototype;Public Health Medicine (Field);Resistance To Bacteria;Resistance To Bacterial;Resistant To Bacteria;Resistant To Bacterial;Safety Testing;Skin Disorder;Stroke;Surgery;Tissue Repair;Wound

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 Relevance Statement:


Public Health Relevance:
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.

NIH Spending Category:
Bioengineering; Diabetes; Emerging Infectious Diseases; Infectious Diseases

Project Terms:
Advanced Development; Affect; Age-Years; alternative treatment; American; Amputation; Animal Hospitals; Animals; Bacteria; Bacterial Infections; bacterial resistance; Biological; Burn injury; Caring; Chemicals; Chronic; Clinical; Clinical Research; clinically significant; cost; Data; Decubitus ulcer; Development; Diabetes Mellitus; diabetic; Diabetic mouse; Disease; Disinfection; Effectiveness; Engineering; engineering design; Environment; Equus caballus; Evaluation; Excision; Fluorescence Microscopy; General Population; Generations; Goals; Healed; healing; Health Care Costs; health related quality of life; Human; improved; In Vitro; in vivo; Incidence; Injury; Investigation; Lead; Legal patent; Livestock; Location; Lower Extremity; Medicaid; Medical center; medical schools; Medicare; meetings; Mental Depression; microbial; Microbial Biofilms; microorganism; Mind; Modeling; Montana; Mortality Vital Statistics; mutant; new technology; Nitrogen; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Outpatients; pathogen; Patients; Penetration; Performance; performance tests; Peripheral arterial disease; Phase; Physiology; Plasma; Plasma Cells; Play; Process; professor; prototype; Pseudomonas aeruginosa; public health medicine (field); public health relevance; Recurrent Malignant Neoplasm; Research; research study; response; Risk; Rodent; Role; Safety; Services; Small Business Innovation Research Grant; Splint Device; Staphylococcus aureus; Sterilization; success; Technology; Tennessee; Testing; Therapeutic; Time; Tissues; transcriptomics; United States; Universities; Venous; Visit; Work; wound; Wound Healing; Yeasts