Study of Thymosin Beta 4 in Patients With Pressure Ulcers

What Was Tested

In this phase 2 trial, researchers set out to test TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length).

It had two arms (groups): 1 (placebo comparator) and 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

PU is caused by prolonged pressure or rubbing of the body in areas prone to moisture and friction.

PU affects primarily elderly, bedridden patients.

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 Took Part

72 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed Consent Form signed by the patient or patient's legal representative. Inpatients and outpatients. At least 1 PU with full-thickness skin loss and no joint capsule or bone exposure. Surface area between 5 and 70 cm2. Ulcer present and stable for at least 1 month before enrollment.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment; history of adverse events to any ingredients of study medication; neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the patient's participation in or completion of the study.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this TB-500 (Thymosin Beta-4 fragment) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The TB-500 (Thymosin Beta-4 fragment) group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2006-05 with completion listed for 2008-12.

It ran at 12 sites in United States (12).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days (time frame: Up to 84 days).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length) in 72 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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