Status:
COMPLETED
Study of Thymosin Beta 4 in Patients With Pressure Ulcers
Lead Sponsor:
RegeneRx Biopharmaceuticals, Inc.
Conditions:
Pressure Ulcers
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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
Detailed Description
The purpose of this double-blind, placebo-controlled, dose-escalation study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with...
Eligibility Criteria
Inclusion
- 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.)
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00382174
Start Date
May 1 2006
End Date
December 1 2008
Last Update
February 1 2010
Active Locations (12)
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1
Institute for Advanced Wound Care
Montgomery, Alabama, United States, 36111
2
Impact Clinical Trials
Beverly Hills, California, United States, 90211
3
Long Beach VAMC
Long Beach, California, United States, 90822
4
Bay Pines VA Medical Center
Bay Pines, Florida, United States, 33744