Thymosin beta-4 and venous ulcers: clinical remarks on a European prospective, randomized study on safety, tolerability, and enhancement on healing

What Was Tested

This randomized controlled trial paper looks at TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length).

Three groups of patients, coming from 10 sites, 5 from Italy and 5 from Poland, will be enrolled sequentially.

So, the study design comprehends 72 patients treated for 84 days and followed for 14 days at the end of treatment.

Who Took Part

According to the abstract, 72 patients were involved.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

The patients were allocated by chance, so the TB-500 (Thymosin Beta-4 fragment) group and the comparison group should start out alike.

Blinding on both sides kept the patients and researchers unaware of who received TB-500 (Thymosin Beta-4 fragment).

A placebo (an inactive look-alike) gave the TB-500 (Thymosin Beta-4 fragment) group a baseline to be compared against.

The methods mention a period of 84 days.

What Was Measured

Blood samples will be taken on day 0 and at the end of treatment visit to measure plasma levels of Tbeta-4.

The subject headings attached to it are Chronic Disease, Europe, Safety, Thymosin, Varicose Ulcer, Wound Healing and Thymosin beta(4).

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length) in 72 patients over 84 days.

The publication is from 2007 (Annals of the New York Academy of Sciences), a journal based in United States.

More context: the TB-500 (Thymosin Beta-4 fragment) compound page and the Thymosin Beta-4 (full length) compound page, all human trials.