Jodi C McDaniel 1, Jamie Rausch 2, Alai Tan
Main idea: This trial will provide new evidence about the effectiveness of EPA (eicosapentaenoic acid) + DHA (docosahexaenoic acid) oral therapy to target and reduce excessive PMN activation systemically and locally in patients with chronic venous leg ulcers.
Background: Chronic venous leg ulcers cause significant infirmity for an estimated 9.7 million people annually. Advanced therapies are needed because standard topical therapies are often ineffective or yield only short-term wound healing. We are testing a new oral therapy containing the bioactive elements of fish oil.
Methods: This double-blind RCT will include 248 eligible adults 55 years of age with CVLUs receiving standard care at a large Midwest outpatient wound clinic. Participants are randomized to two groups: 12 weeks of daily oral therapy with EPA + DHA or daily therapy with placebo. At 0, 4, 8, and 12 weeks, across the two groups, we are pursuing three specific aims: Aim 1. Compare levels of EPA+DHA-derived lipid mediators, and inflammatory cytokines in blood and wound fluid; Aim 2. Compare PMN activation and PMN-derived protease levels in wound fluid.