Study of Thymosin Beta 4 in Patients With Pressure Ulcers

RegeneRx Biopharmaceuticals, Inc. · ClinicalTrials.gov registration with posted results

Wounds healed by day 84 in 8 of 54 patients on Tβ4 (15%) and 3 of 18 on placebo (17%). The trial's primary endpoint was safety, and it was met; the healing rates were the same in both arms.

Population

Patients with pressure ulcers

Intervention

Topical Tβ4 at three doses for up to 84 days (54 patients)

Comparator

Placebo (18 patients)

Limitations

Powered for safety, not efficacy, so the identical healing rates are not a formal negative test; results posted on the registry with no peer-reviewed report indexed.