Objective This study evaluates the safety and efficacy of topical beta-adrenergic antagonists plus standard care compared to standard care alone as measured by time to complete re-epithelialization in the treatment of venous ulcer.
Methodology This is a randomized, parallel-group, placebo-controlled study. The sample is 40 healthy volunteers between 18 and 85 years of age who have a nonhealing venous ulcer with a surface area between 2 to 20 cm2. Participants are recruited and treated at the Northern California VA Dermatology Clinic. After 2 weeks of initial screening, study participants are randomized. The beta-adrenergic antagonist (BAA) treatment group receives topical timolol maleated ophthalmic solution in addition to standard care. The dosage used is 0.25 mg/3cm2 /day, which is comparable to the recommended ocular dosage. The placebo group receives saline solution in addition to standard care. Participants apply medication daily with protocol-specified standard care at home. Participants visit the clinic weekly for up to 12 weeks for determination of re-epithelialization. At each visit, wound tracing and photography of study ulcer are performed post-débridement. Following determination of 100% wound closure, subjects are seen for one follow-up visit 1 month after. Final evaluation of the durability of the wound closure of the study ulcer is made as assessed by the investigator, planimetry, and photography.
Findings The expected outcome of this clinical trial is an increased wound healing rate of 60% to 90% in the BAA treatment group and without significant increase in the placebo group.
Conclusion Venous ulcer accounts for 80% of leg ulcers in the US and is slow and difficult to heal. Our laboratory has demonstrated that beta-adrenergic agonists decrease the cell migration rate in in vitro and ex vivo assays and that beta-adrenergic antagonists increase wound healing in in vitro assays. Based on these findings, we hypothesize that beta-adrenergic antagonists will accelerate epithelial cell migration in vivo. This translational research study may help point to a more effective therapeutic approach for venous ulcer and thus significantly improve patients' quality of life as well as reduce the time and cost of venous ulcer management.
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