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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 Venous Stasis 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 Venous Stasis ulcers (VS). VS ulcers are common types of chronic wounds that develop on the ankle or lower leg in patients with chronic vascular disease. In these patients, blood flow in the lower extremities is impaired, leading to edema (swelling) and mild redness and scaling of the skin that gradually progress to ulceration. 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 Locations: Italy and Poland, 10 sites Expected Total Enrollment: 72 Targeted Study Completion: Q3 2008 Study Start: Recruiting Objectives:
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