Study of Thymosin Beta 4 in Patients With Pressure Ulcers

Inclusion criteria

• Informed Consent Form signed by the patient or patient's legal representative
• Inpatients and outpatients
• At least 1 PU with full-thickness skin loss and no joint capsule or bone exposure
• Surface area between 5 and 70 cm2
• 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 immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment. Systemic steroids not allowed 30 days prior to enrollment. Topical therapy other than steroidal is allowed up to 7 days prior to enrollment
• History of adverse events to any ingredients of study medication
• Neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the patient's participation in or completion of the study
• Arterial or venous disorder resulting in ulcerated wounds
• Diabetes mellitus except if disease is determined to be under control with a glycosylated hemoglobin ≤8.5% of total hemoglobin
• Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)