DRUG
Placebo
Topical administration of 0.00% thymosin beta 4 qd up to 84 days
Status
Completed
Phase
Phase 2
Enrollment
72
Locations
12
Results
Posted
Publications
0
Study 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
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 Pressure Ulcers (PU). PU is caused by prolonged pressure or rubbing of the body in areas prone to moisture and friction. PU affects primarily elderly, bedridden patients. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.
Interventions
DRUG
Topical administration of 0.00% thymosin beta 4 qd up to 84 days
DRUG
Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
Timeline
First posted
Sep 28, 2006
Study start
May 2006
Primary completion
Dec 2008
Study completion
Dec 2008
Results posted
Feb 1, 2010
Registry updated
Feb 1, 2010
Outcomes
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
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.)
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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