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Trial Synopsis 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 Purpose: The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Pressure Ulcers (PU). PU are caused by prolonged pressure or rubbing of the body in areas prone to moisture and friction. PU affect 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: Phase 2, Interventional Study Design: Randomized, double-blind, placebo-controlled, dose-escalation study Location: U.S., 15 to 20 sites Expected Total Enrollment: 72 patients Targeted Study Completion: Q3 2008 Study Stage: Recruiting ClinicalTrials.gov ID: NCT00382174 Objectives:
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