Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

NCT ID: NCT00832091

Last Updated: 2010-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-01-31

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.

Conditions

Venous Stasis Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

Thymosin Beta 4

Intervention Type: DRUG

There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active 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

2

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Thymosin Beta 4

There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active 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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Tβ4; RGN-137 (topical gel)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

sigma-tau i.f.r. S.p.A.

INDUSTRY

Sponsor Role: collaborator

RegeneRx Biopharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Istituto Dermopatico dell'Immacolata (IDI), Rome, ITaly

Principal Investigators

Giorgio Guarnera, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Dermopatico Dell'Immacolata, Rome , Italy

Locations

Chirurgia Vascolare

Bologna, , Italy

Università degli Studi di Napoli - Federico II

Naples, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Unità Operativa di Angiologia Azienda Ospedaliera di Padova

Padua, , Italy

Istituto Dermopatico dell'Immacolata (IDI)

Rome, , Italy

Klinika Chirurgii Naczyń i Angiologii

Lublin, , Poland

Klinika Chirurgii Ogólnej i Naczyniowej,

Szczecin, , Poland

Oddział Angiologiczny

Wroclaw, , Poland

Countries

Italy; Poland

Other Identifiers

SSVS

Identifier Type: -

Identifier Source: org_study_id