Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds

Inclusion Criteria

• •The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart. For subjects that agree to have their wound photographed for the trial, a photo release consent form must be signed and documented as well.
• •Age 18 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.
• •Females, if of child-bearing potential, have a negative urine pregnancy test and agree to use acceptable contraception during the study. Adequate birth control methods are defined as: hormonal-topical, oral, implantable, or injectable contraceptives; mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner.
• •Have a partial or full thickness PU on the foot or ankle or DFU of \<= 6 months duration and between ≥1.0 and ≤ 12.0 cm² in area.
• •Are willing to make all required study visits.
• •Are willing to follow instructions, in the opinion of the Investigator.
• •Have, within 12 weeks prior to randomization, a serum albumin level ≥ 2.0 g/dL (20 g/L); Alkaline phosphatase, AST, ALT, serum creatinine, and BUN levels \< 3 x upper limit of normal; HbA1C ≤ 12%; and Hemoglobin \>= 8 g/dL. The most recently obtained value must be evaluated against these criteria. Please refer to Appendix 18.1.5
• •Have arterial supply adequacy confirmed by an Ankle Brachial Index (ABI) \>= 0.7 and ≤ 1.1 or if the ABI is \> 1.1, either a TcPO2 \>= 40 mmHg, as measured on the foot, or great toe pressure ≥ 50 mm/Hg,
• •For ulcers that will require surgical debridement prior to enrollment, the wound must be expected to remain a partial thickness wound after debridement.