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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
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
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
Chirurgia Vascolare
Bologna, Italy
Università degli Studi di Napoli - Federico II
Naples, Italy
Azienda Ospedaliera di Padova
Padova, Italy
Unità Operativa di Angiologia Azienda Ospedaliera di Padova
Padova, Italy
Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for 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
Time frame: Up to 84 days
Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers
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
Time frame: Up to 84 days
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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