PROMOTION OF WOUND VASCULARIZATION AND CLOSURE

Information

  • Research Project
  • 6141364
  • ApplicationId
    6141364
  • Core Project Number
    R43GM061437
  • Full Project Number
    1R43GM061437-01
  • Serial Number
    61437
  • FOA Number
  • Sub Project Id
  • Project Start Date
    8/15/2000 - 23 years ago
  • Project End Date
    2/14/2001 - 23 years ago
  • Program Officer Name
    MOSHELL, ALAN N.
  • Budget Start Date
    8/15/2000 - 23 years ago
  • Budget End Date
    2/14/2001 - 23 years ago
  • Fiscal Year
    2000
  • Support Year
    1
  • Suffix
  • Award Notice Date
    8/3/2000 - 23 years ago
Organizations

PROMOTION OF WOUND VASCULARIZATION AND CLOSURE

Progression of diabetic foot ulcers is the leading cause of lower limb amputation in the U.S. The high incidence of diabetic foot complications demonstrates aggressive conventional therapy is neither realistically accomplished, nor cost-effective. Furthermore, conventional therapy does not treat the causative microcirculatory pathology. The overall project goal is to evaluate Encelle, Inc.'s proprietary hydrogel matrix (E-Matrix) as a single injection therapy for vascularization of skin lesions. The project will develop characterization assays for E-Matrix to understand the physical and chemical properties of the matrix, measure manufacturing consistency and E-Matrix stability. Efficacy will be evaluated using two wound models resulting from compromised vasculature in pigs. Surgical interruption of the skin vasculature, or phenol chemical burns, will be induced at six separate sites in two cohorts of four pigs each. The effect on wound size and rate of closure following no treatment, a single control injection, or a single E-Matrix injection circumferentially and centrally, will be studied. After 14 days, the animals will be sacrificed, and tissue samples obtained for immunohistochemical preparation and analysis. Tissue analysis using histological and immunohistochemical methods will qualitatively and semi-quantitatively delineate the vascular density at wound sites, differentiation of blood vessel types, the number and type of infiltrating cells, mitotic indices, apoptosis during healing, amount and type of collagen formed and induction of metalloproteinases. Understanding the detailed tissue and cellular response to E-Matrix treatment using reproducibly manufactured E-Matrix with known physical and chemical characteristics in well-defined animal models will provide a strong baseline for the commercial development of this product. PROPOSED COMMERCIAL APPLICATIONS: Potential applications of E-Matrix include the treatment of conditions associated with compromised vascular flow including diabetic ulcers, decubitus ulcers, burns, atherosclerosis of the peripheral vasculature, coronary artery disease, and stroke.

IC Name
NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
  • Activity
    R43
  • Administering IC
    GM
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    99546
  • Sub Project Total Cost
  • ARRA Funded
  • CFDA Code
    821
  • Ed Inst. Type
  • Funding ICs
    NIGMS:99546\
  • Funding Mechanism
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    ENCELLE, INC.
  • Organization Department
  • Organization DUNS
    848651667
  • Organization City
    Greenville
  • Organization State
    NC
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    27834
  • Organization District
    UNITED STATES