Clinical Trial: Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers
Detailed Summary: The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Venous Stasis (VS) ulcers. VS ulcers 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.
Sponsor: RegeneRx Biopharmaceuticals, Inc.
Current Primary Outcome: Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days [ Time Frame: Up to 84 days ]
Original Primary Outcome: Safety and tolerability of TB4,administered topically qd, for up to 84 days in patients with Venous Stasis ulcers [ Time Frame: up tp 84 days ]
Current Secondary Outcome: Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers [ Time Frame: Up to 84 days ]
Original Secondary Outcome: Wound healing effectiveness of Tβ4, administered topically qd for up to 84 days, in patients with Venous Stasis ulcers [ Time Frame: Up to 84 days ]
Information By: RegeneRx Biopharmaceuticals, Inc.
Dates:
Date Received: January 28, 2009
Date Started: July 2006
Date Completion:
Last Updated: March 24, 2010
Last Verified: March 2010