Impact of omega-3 fatty acid oral therapy on healing of chronic venous leg ulcers in older adults: Study protocol for a randomized controlled single-center trial

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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.

Abstract

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.

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