Study of Thymosin Beta 4 in Patients With Venous Stasis 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 (active comparator) and 2 (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 72 actual participants took part.

It was open to people of any sex aged from 18 years up to 79 years.

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

Examples of who could join: 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.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got TB-500 (Thymosin Beta-4 fragment) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on TB-500 (Thymosin Beta-4 fragment), so expectations could not easily colour the readings.

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

It started in 2006-07 with completion listed for 2009-01.

It ran at 8 sites in Italy (5) and Poland (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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).

It also tracked 1 secondary outcome, for example Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers.

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.