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NCT Number: NCT00832091

Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

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

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Key information

Conditions

Venous Stasis Ulcers Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Venous Insufficiency

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chirurgia Vascolare, Bologna, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thymosin Beta 4

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

Other names: Tβ4, RGN-137 (topical gel)

Placebo

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

RegeneRx Biopharmaceuticals, Inc.

Industry

Collaborators

  • sigma-tau i.f.r. S.p.A.

Registry information

Official study 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

Acronym: SSVS

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 29, 2009
Registry last updated
Mar 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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