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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Topical administration of 0.00% thymosin beta 4 qd up to 84 days
Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
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
Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days
All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population
Time frame: Up to 84 days
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days
Incidence of wound healing at the end of the study, Day 84
Time frame: Up to 84 days
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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
...and 2 more locations