Trial Information

Summary: Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients with Pressure Ulcers.

A double-blind, placebo-controlled study using 3 concentrations of thymosin beta 4 (Tß4) to evaluate its safety and tolerability, when administered topically once daily (qd) for up to 84 days, in patients with a Stage III or Stage IV pressure ulcer. There will be 3 groups of patients. Each group will include 24 patients requiring treatment for pressure ulcers.

Inclusion Criteria:

• Informed Consent Form signed by the patient or patient’s legal representative.
• Male or female inpatients or outpatients, aged 18 through 85 years, inclusive.
• Available caregiver capable of following study drug administration guidelines and maintaining Standard of Care.
• At least 1 pressure ulcer with surface area between 5 and 70 cm2.
• Stage III or IV disease.
• Ulcer present and stable for at least 1 month before enrollment. Exclusion Criteria:
• Clinically significant abnormalities on Screening laboratory tests.
• Current or former malignancy, except basal cell carcinoma, which is permitted.
• 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 or Baseline, for female patients of childbearing potential.)

If you would like to learn more about participating in this study, please send an e-mail message using the form below.