Pressure Ulcers Clinical Trial
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
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers
Status | Completed |
Enrollment | 72 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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.) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Bay Pines VA Medical Center | Bay Pines | Florida |
United States | Impact Clinical Trials | Beverly Hills | California |
United States | University of North Carolina Hospital | Chapel Hill | North Carolina |
United States | Hines VAMC | Hines | Illinois |
United States | Long Beach VAMC | Long Beach | California |
United States | A+ Research, Inc. | Miami | Florida |
United States | Institute for Advanced Wound Care | Montgomery | Alabama |
United States | Mount Dora Research Center, Inc. | Mount Dora | Florida |
United States | New York Presbyterian Hospital | New York | New York |
United States | Mcguire VA Medical Center | Richmond | Virginia |
United States | New Bridge Medical Center | Warren | Pennsylvania |
United States | Wound Healing Laboratory Plastic Surgery UMass Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
RegeneRx Biopharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Tolerability of Thymosin Beta 4 (Tß4)Applied for up to 84 Days | Up to 84 days | Yes | |
Secondary | Wound Healing Effectiveness of Tß4 Applied for up to 84 Days | Up to 84 days | No |
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