Study of Thymosin Beta 4 in Patients With Pressure Ulcers

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RegeneRx Biopharmaceuticals, Inc.

Criteria

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.)