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 primary endpoint was safety: serious adverse events were recorded in 13 of 54 on Tβ4 and 5 of 18 on placebo, with no statistical analysis posted, and 37 of 54 and 14 of 18 completed the 84 days.

Population

Patients with pressure ulcers

Intervention

Topical Tβ4 gel at 0.01%, 0.02% or 0.1% once daily for up to 84 days (54 patients)

Comparator

Placebo (18 patients)

Limitations

Powered for safety, not efficacy, so the near-identical healing rates are not a formal negative test; 13 sites, sponsored by RegeneRx; results posted on the registry with no peer-reviewed report indexed.