Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

Phase 2

Completed

• Conditions: Venous Stasis Ulcers
• Interventions: Drug: Placebo; Drug: Thymosin Beta 4

• Registration Number: NCT00832091
• Lead Sponsor: RegeneRx Biopharmaceuticals, Inc.

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 Description

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.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Results First Submitted: 2010-01-19
• Results First Submitted QC: 2010-02-22
• Status Verified: 2010-03
• Results First Posted: 2010-03-24
• Last Update Submitted: 2010-03-24
• Last Update Posted: 2010-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Informed Consent Form signed by the patient
• Male or female, between 18 and 79 years of age
• At least one venous leg ulceration stable for at least 6 weeks before enrollment
• Surface area between 3 and 30 cm2

Exclusion Criteria

• Have clinical evidence of active infection on the index ulcer
• Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment
• Use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment
• History of adverse reaction to any ingredients of the study medication
• Clinically significant neurological, cardiovascular, respiratory, hepatic, renal, metabolic and dermatologic disease other than venous ulcers
• Current or former malignancy
• Arterial disorder resulting in ulcerated ulcers
• Diabetes mellitus
• Pregnant or lactating (breastfeeding) women. A serum pregnancy test will be performed at screening for female patients of childbearing potential

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days
1	Thymosin Beta 4	There are 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were 3 concentrations used for topical administration to the active drug groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days	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

Secondary Outcome Measures

Name	Time	Method
Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers	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

Trial Locations

Locations (8)

Università degli Studi di Napoli - Federico II; 🇮🇹 Naples, Italy

Istituto Dermopatico dell'Immacolata (IDI); 🇮🇹 Rome, Italy

Klinika Chirurgii Naczyń i Angiologii; 🇵🇱 Lublin, Poland

Chirurgia Vascolare; 🇮🇹 Bologna, Italy

Unità Operativa di Angiologia Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Oddział Angiologiczny; 🇵🇱 Wrocław, Poland

Klinika Chirurgii Ogólnej i Naczyniowej,; 🇵🇱 Szczecin, Poland