HP011-101, HP828-101, and Standard Care for Pressure Ulcers

Inclusion Criteria: * Subjects must meet all of the following criteria to be eligible for the study: * Provide informed consent, or informed assent if less than 18 years of age. * Age 12 years or older, of either sex, and of any race or skin type, provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments. * Have a pressure ulcer ≥ 5 cm² and ≤ 100 cm² in area (measured as greatest length x perpendicular width of the area of non-blanching erythema or denuded skin, whichever is greater), and will remain hospitalized for at least three weeks. * Are capable of maintaining an adequate nutritional status. * All female subjects must have a negative urinary pregnancy test. * Have, within 12 weeks prior to screening, clinical laboratory test results indicating: * Serum albumin ≥ 3.0 g/dL (30 g/L) * Alkaline phosphatase, ALT, AST, BUN and serum creatinine levels \< 3x upper limit of the Healthpoint normal range (refer to Section 18.1.2) * HbA1C ≤ 12% * Hemoglobin ≥ 10 g/dL * The most recently obtained values must be evaluated against these criteria. If these values are not available from a blood sample within 12 weeks of screening, blood must be drawn at screening and these laboratory values determined. * For ulcers that will require surgical debridement prior to enrollment, the wound must be expected to remain a Stage I or Stage II partial thickness wound after debridement. Exclusion Criteria: * Subjects meeting any of…