First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers
Clinical Summary
View sourceWhat was studied
First-in-human, prospective, open-label, multi-centre, dose-escalation study of topical tarumase for enzymatic debridement in venous leg ulcer patients (n=43), applied three times weekly for up to 4 weeks (12 applications), assessing systemic safety, local tolerability, and early signals of debridement and healing.
Key findings
Tarumase was well tolerated with no indications of systemic absorption, no antibody generation, and no systemic coagulation effects; locally, no pain on application, no itching, and no increases in erythema, oedema, exudate, or bleeding were observed, with only a few treatment-emergent adverse events. Higher concentrations showed trends toward faster and improved debridement—especially in ulcers with significant baseline slough—and trends toward faster healing (more granulation tissue, increased linear healing, reduced surface area) over 4 weeks.
Study limitations
Open-label, first-in-human dose-escalation with a small sample (n=43) and no control group. Efficacy findings are described as trends without quantitative outcomes.
Clinical implications
In venous leg ulcers, short-term topical tarumase appears locally and systemically well tolerated over 4 weeks, with early signals of dose-related debridement and healing benefits. Use remains investigational pending controlled trials.
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