Study of Thymosin Beta 4 in Patients With Pressure Ulcers
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00382174 |
Recruitment Status :
Completed
First Posted : September 28, 2006
Results First Posted : February 1, 2010
Last Update Posted : February 1, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pressure Ulcers | Drug: Placebo Drug: Thymosin Beta 4 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients With Pressure Ulcers |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days
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Drug: Placebo
Topical administration of 0.00% thymosin beta 4 qd up to 84 days |
Active Comparator: 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
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Drug: Thymosin Beta 4
Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days |
- Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days [ Time Frame: Up to 84 days ]All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population
- Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days [ Time Frame: Up to 84 days ]Incidence of wound healing at the end of the study, Day 84

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382174
United States, Alabama | |
Institute for Advanced Wound Care | |
Montgomery, Alabama, United States, 36111 | |
United States, California | |
Impact Clinical Trials | |
Beverly Hills, California, United States, 90211 | |
Long Beach VAMC | |
Long Beach, California, United States, 90822 | |
United States, Florida | |
Bay Pines VA Medical Center | |
Bay Pines, Florida, United States, 33744 | |
A+ Research, Inc. | |
Miami, Florida, United States, 33115 | |
Mount Dora Research Center, Inc. | |
Mount Dora, Florida, United States, 32757 | |
United States, Illinois | |
Hines VAMC | |
Hines, Illinois, United States, 60141 | |
United States, Massachusetts | |
Wound Healing Laboratory Plastic Surgery UMass Medical Center | |
Worcester, Massachusetts, United States, 01655 | |
United States, New York | |
New York Presbyterian Hospital | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
University of North Carolina Hospital | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Pennsylvania | |
New Bridge Medical Center | |
Warren, Pennsylvania, United States, 16365 | |
United States, Virginia | |
Mcguire VA Medical Center | |
Richmond, Virginia, United States, 23249 |
Principal Investigator: | Terry Treadwell, MD | Institute for Advanced Wound Care |
Responsible Party: | David Crockford, VP, Clinical and Regulatory Affairs, RegeneRx Biopharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00382174 |
Other Study ID Numbers: |
SSPU |
First Posted: | September 28, 2006 Key Record Dates |
Results First Posted: | February 1, 2010 |
Last Update Posted: | February 1, 2010 |
Last Verified: | January 2010 |
pressure ulcers cutaneous wound- healing chronic wound-healing Thymosin Beta 4 laminin-5 |
Pressure Ulcer Ulcer Pathologic Processes Skin Ulcer Skin Diseases |