Abstract:
: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.
journal_name
Ann N Y Acad Scijournal_title
Annals of the New York Academy of Sciencesauthors
Guarnera G,DeRosa A,Camerini R,8 European sites.doi
10.1111/j.1749-6632.2010.05490.xsubject
Has Abstractpub_date
2010-04-01 00:00:00pages
207-12eissn
0077-8923issn
1749-6632pii
NYAS5490journal_volume
1194pub_type
杂志文章,多中心研究,随机对照试验abstract::Recent immunologic studies have provided important new information about the nature of AHF deficiency diseases and the structure and synthesis of this protein. They provide, moreover, a considerably improved ability to identify the carrier state in hemophilia A. Additional progress may be possible in the identificatio...
journal_title:Annals of the New York Academy of Sciences
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