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Topically applied recombinant tissue plasminogen activator for the treatment of venous ulcers. Preliminary report
V Falanga1, P Carson, A Greenberg
1Department of Dermatology and Cutaneous Surgery, University of Miami, University of Miami School of Medicine, FL 33101, USA.
Background:
Increasing evidence suggests that fibrin deposition is an important pathogenic component of venous ulceration and that fibrin removal could accelerate ulcer healing.
Objective:
We sought to determine whether topical application of recombinant tissue plasminogen activator (tPA) compounded in 1% hyaluronate acid (HA) can be used safely in venous ulcers and whether it can accelerate healing.
Methods:
Twelve patients were randomized in a double-blind fashion in three sequential groups of four subjects each, so as to receive daily topical application of either placebo (HA alone, one patient) or tPA/HA (three patients) at escalating doses of 0.25, 0.5, and 1.0 mg/ml of tPA for 4 weeks.
Results:
No safety problems occurred, and we found a close direct correlation between mean ulcer reepithelialization, fibrin removal, and the dose of topically applied tPA (r = 0.991).
Conclusion:
In this first study to examine its usefulness, topically applied tPA appears to be a safe and promising agent for treating venous ulcers.