Study of Thymosin Beta 4 in Patients With Pressure Ulcers
NCT ID: NCT00382174
Last Updated: 2010-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2006-05-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days
Placebo
Topical administration of 0.00% thymosin beta 4 qd up to 84 days
2
3 doses of thymosin beta 4: 0.01% w/w, 0.02% w/w, and 0.1% w/w, administered topically once daily for up to 84 days
Thymosin Beta 4
Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
Interventions
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Placebo
Topical administration of 0.00% thymosin beta 4 qd up to 84 days
Thymosin Beta 4
Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
Eligibility Criteria
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Inclusion Criteria
* 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 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.)
18 Years
85 Years
ALL
No
Sponsors
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RegeneRx Biopharmaceuticals, Inc.
INDUSTRY
Responsible Party
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RegeneRx Biopharmaceuticals, Inc.
Principal Investigators
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Terry Treadwell, MD
Role: PRINCIPAL_INVESTIGATOR
Institute for Advanced Wound Care
Locations
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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
Countries
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Other Identifiers
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SSPU
Identifier Type: -
Identifier Source: org_study_id
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