Clinical trial NCT00832091: Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Stasis Ulcers
Keywords: Venous Stasis Ulcers
venous insufficiency
leg ulcers
Thymosin Beta 4
Laminin-5
Lead sponsor: RegeneRx Biopharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: sigma-tau i.f.r. S.p.A.
First posted: 2009-01-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days
timeFrame: Up to 84 days
Secondary outcomes:
measure: Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers
timeFrame: Up to 84 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Chirurgia Vascolare
city: Naples
country: Italy
facility: Università degli Studi di Napoli - Federico II
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Padova
country: Italy
facility: Unità Operativa di Angiologia Azienda Ospedaliera di Padova
city: Rome
country: Italy
facility: Istituto Dermopatico dell'Immacolata (IDI)
city: Lublin
country: Poland
facility: Klinika Chirurgii Naczyń i Angiologii
city: Szczecin
country: Poland
facility: Klinika Chirurgii Ogólnej i Naczyniowej,
city: Wrocław
country: Poland
facility: Oddział Angiologiczny
Study officials:
affiliation: Istituto Dermopatico Dell'Immacolata, Rome , Italy
name: Giorgio Guarnera, MD
role: PRINCIPAL_INVESTIGATOR
References: