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 ]

All Treatment-Emergent (TE) Serious Adverse Events (SAEs) and Adverse Events (AEs) by treatment with Tβ4 gel at the combined 3 doses in the safety population with Venous Stasis (VS) ulcers for up to 84 days. TEAE is defined as a side effect that begins or that worsens in severity after the application of at least one dose of Tβ4 gel on the venous stasis ulcer. A pre-existing condition is not considered an AE, but if it worsens during the study, then it may be considered an AE


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 ]

Wound healing effectiveness of Tβ4 gel applied once daily for up to 84 days to patients expressed as the number of patients whose wound had closed without drainage at the end of the study, Day 84


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