The effect of thymosin treatment of venous ulcers

Guarnera G, DeRosa A, Camerini R · Annals of the New York Academy of Sciences

Safety was comparable to placebo. The registry's posted results show 12 of 55 Tβ4 patients (22%) and 4 of 17 placebo patients (24%) with wounds closed at day 84; the paper reports healing in "about 25% of patients" and singles out the 0.03% dose as potentially active.

Population

Patients with venous stasis ulcers at eight European sites

Intervention

Topical Tβ4 gel once daily for up to 84 days, dose-escalation across three concentrations (55 patients)

Comparator

Placebo gel (17 patients)

Limitations

Dose-escalation design with small per-dose arms; the reported "about 25% heal" figure is the rate in both arms, and the 0.03% signal is a subgroup within a trial powered for safety (NCT00832091).