The effect of thymosin treatment of venous ulcers.
Venous ulcers are responsible for about 70% of the chronic ulcers of the lower limbs. Standard of care includes compression, dressings, debridement of devitalized tissue, and infection control. Thymosin beta 4 (Tbeta4), a synthetic copy of the naturally occurring 43 amino-acid peptide, has been found to have wound healing and anti-inflammatory properties, and is thought to exert its therapeutic effect through promotion of keratinocyte and endothelial cell migration, increased collagen deposition, and stimulation of angiogenesis. To assess the safety, tolerability, and efficacy of topically administered Tbeta4 in patients with venous stasis ulcers, a double-blind, placebo-controlled, dose-escalation study was conducted in eight European sites (five in Italy and three in Poland) that enrolled and randomized 73 patients. The safety profile of all doses of administered Tbeta4 was deemed acceptable and comparable to placebo. Efficacy findings from this Phase 2 study suggest that a Tbeta4 dose of 0.03% may have the potential to accelerate wound healing and that complete wound healing can be achieved within 3 months in about 25% of the patients, especially among those whose wounds are small to moderate in size or mild to moderate in severity.
Guarnera
G
G
Vascular Ulcer Unit, Department of Vascular Surgery and Pathology, Istituto Dermopatico dell'Immacolata, Rome, Italy. gguarnera@tiscali.it
DeRosa
A
A
Camerini
R
R
D000287:Administration, Topical; D002465:Cell Movement / Q000187:drug effects; D003646:Debridement; D004311:Double-Blind Method; D006728:Hormones / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007155:Immunologic Factors / Q000494:pharmacology / Q000627:therapeutic use; D007558:Italy; D015603:Keratinocytes / Q000187:drug effects / Q000502:physiology; D008875:Middle Aged; D010919:Placebos / Q000494:pharmacology / Q000627:therapeutic use; D011044:Poland; D012449:Safety; D013947:Thymosin / Q000494:pharmacology / Q000627:therapeutic use*; D014647:Varicose Ulcer / Q000188:drug therapy*; D014945:Wound Healing / Q000187:drug effects* / Q000502:physiology; D000099201:Thymosin beta(4)
D006728:Hormones; D007155:Immunologic Factors; D010919:Placebos; D013947:Thymosin; D000099201:Thymosin beta(4)