Study of Thymosin Beta 4 in Patients With Pressure Ulcers

Completed · Phase 2 · Has a placebo group

Conditions studied: Pressure Ulcers

In brief

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

Key facts

Study ID

NCT00382174

Run by

RegeneRx Biopharmaceuticals, Inc.

People needed

72

Starts

2006-05-01

Expected to finish

2008-12-01

Last updated by the study team

2010-02-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Institute for Advanced Wound Care — Montgomery, Alabama, United States
• Impact Clinical Trials — Beverly Hills, California, United States
• Long Beach VAMC — Long Beach, California, United States
• Bay Pines VA Medical Center — Bay Pines, Florida, United States
• A+ Research, Inc. — Miami, Florida, United States
• Mount Dora Research Center, Inc. — Mt. Dora, Florida, United States
• Hines VAMC — Hines, Illinois, United States
• Wound Healing Laboratory Plastic Surgery UMass Medical Center — Worcester, Massachusetts, United States
• New York Presbyterian Hospital — New York, New York, United States
• University of North Carolina Hospital — Chapel Hill, North Carolina, United States
• New Bridge Medical Center — Warren, Pennsylvania, United States
• Mcguire VA Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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