Eligibility:

Inclusion Criteria:

• Ages eligible for the study: 18 through 85 years of age.
• Both genders are eligible.
• Informed Consent Form signed by the patient or patient's legal representative.
• At least 1 PU with full-thickness skin loss and no joint capsule or bone exposure.
• Surface area between 5 and 70 cm², active lesion.
• Ulcer present and stable for at least 1 month before enrollment.

Exclusion Criteria:

• Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment.
• Use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment.
• History of adverse events to any ingredients of study medication.
• Arterial or venous disorder resulting in ulcerated wounds.
• Diabetes mellitus.
• Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)