Current partner codePEPTIDESDE
NCT00832091·Phase 2·INTERVENTIONAL

Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

Status

Completed

Phase

Phase 2

Enrollment

72

Locations

8

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

DRUG

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

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

Timeline

From registration to results.

  1. First posted

    Jan 29, 2009

  2. Study start

    Jul 2006

  3. Primary completion

    Jan 2009

  4. Study completion

    Jan 2009

  5. Results posted

    Mar 24, 2010

  6. Registry updated

    Mar 30, 2010

Outcomes

What the study measures.

Primary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
79 Years
Sex
ALL
Healthy volunteers
No

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 locations

8 registered sites.

Italy · Poland. Showing up to 24 locations stored in the fast local snapshot.

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

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Thymosin Beta-4.

Related PeptideStat pages

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