Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities

Inclusion Criteria: * Able to read, understand and sign the informed consent form (ICF) * Available and willing to complete all study assessments * At least 12 weeks post lower extremity revascularization procedure, if one has been performed * Have chronic ulcer(s) of the lower extremities with the following characteristics: * Of diabetic or vascular etiology * Duration of ≥4 weeks, unresponsive to SOC * ≤20 cm2 in area * Extend through the full thickness of the skin but not down to muscle, tendon, or bone * For subjects with VLU: * Ulcer area is ≥1.5 cm2 and ≤20 cm2 and with a clean, granulating base with minimal adherent slough * Ulcer location is at or above the ankle (malleolus) and below the knee * Ulcer location is appropriate for use of compression therapy treatment * For subjects with DFU: * Ulcer area is ≥1.5 cm2 and ≤ 20 cm2 and is amenable to off-loading * Subject has diabetes mellitus (Type 1 or Type 2), requiring insulin or oral/injectable medications to control blood glucose levels * Glycosylated hemoglobin (HbA1c) level at screening is \<12% * Adequate circulation to the affected lower extremities * Total serum bilirubin, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), hemoglobin, WBC, and PLT count all within limits specified in study protocol * No renal impairment or mild renal impairment, defined as creatinine clearance ≥50 mL/min (by Cockroft-Gault estimation) * Male subjects and female subjects of childbearing potential must use acceptable methods of contraception Exclusion Criteria: * Clinical evidence of ongoing infection and/or receipt of IV, oral, or topical antimicrobials at the Baseline Visit * Wheelchair bound or bed-ridden (ambulatory with assistance is acceptable) * Ulceration at the site of amputation * Undergoing renal dialysis * Known or suspected malignancy in the target ulcer, or a history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer) * Documented history of osteomyelitis at the target ulcer location within 6 months of screening * Current treatment or anticipated need for treatment over the course of the study with: * Immunosuppressants (including topical or systemic corticosteroids or glucocorticoids) * Cytotoxic chemotherapy * Growth hormone * Oral or systemic antifungal or antituberculosis treatment * History of radiation at the ulcer site * New York Heart Association Class III or IV congestive heart failure or uncontrolled cardiac dysrhythmia * Diagnosis of autoimmune disease(s) (rheumatoid arthritis, lupus, psoriasis, Sjogren's syndrome) or arthritis requiring corticosteroid treatment * Target ulcer(s) previously treated with negative pressure, hyperbaric oxygen, or tissue engineered materials (eg, Apligraf®, EpiFix® or Dermagraft®) or other scaffold materials (eg, Oasis, Matristem) within 4 weeks prior to Screening Visit * Target ulcer(s) anticipated to require negative pressure wound therapy or hyperbaric oxygen at any time during the study * Subjects with VLU who have: * Deep vein thrombosis diagnosed within 4 weeks prior to Screening Visit * Refusal or inability to tolerate compression therapy * Subjects with DFU who have: * Active Charcot foot (stable chronic Charcot foot is not exclusionary) * Ulcers on toes 2, 3, 4, and/or 5 only (ulcer on plantar surface of the great toe only is not exclusionary) * Pregnant or breast feeding * Allergic to DMSO * Healing of target ulcer is observed to be ≥35% at the end of the Run-in Period (between Screening and Baseline Visits) * Presence of any condition(s) which compromises the subject's ability to complete this study, including subjects with a known history of poor adherence to medical treatment * Subjects who, in the opinion of the Investigator, are not able to comply with study requirements * Treatment with an investigational drug(s) or device(s) within the 4 weeks preceding Screening