Venous leg ulcers (VLUs) are one of the most prevalent types of chronic wounds. The aim of this study was to determine the safety and dose-response efficacy of the human synthetic peptide LL-37 in the treatment of hard-to-heal VLUs. This first-in-man trial included 34 participants with VLUs and comprised a 3-week, open-label, run-in period on placebo, followed by a 4-week randomized double-blind treatment phase with twice weekly applications of LL-37 (0.5, 1.6, or 3.2?mg/mL) or placebo, and a 4-week follow-up. The healing rate constants for 0.5 and 1.6?mg/mL of LL-37 were approximately six- and threefold higher than for placebo (p?=?0.003 for 0.5?mg/mL and p?=?0.088 for 1.6?mg/mL). Square-root transformed wound area data showed improved healing for the 0.5 and 1.6?mg/mL dose groups compared with pretreatment values (p?
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