# Impact of Omega-3 Fatty Acid Oral Therapy on Healing of Chronic Venous Leg Ulcers in Older Adults

> **NIH NIH R01** · OHIO STATE UNIVERSITY · 2020 · $562,689

## Abstract

The proposed research addresses a mission of the National Institute on Aging – to develop understanding and
improve health outcomes of chronic wounds in aging. The goals of the proposed project are to enhance
knowledge of chronic venous leg ulcers (CVLUs) and provide evidence-based guidance in the treatment of
CVLUs, wounds that cause substantial morbidity, disability, hospitalization, and even mortality among older
adults. New therapies for CVLUs are needed because standard topical therapies are often ineffective or yield
only short-term healing. Congruent with PA-16-230, Non-healing Ulcerative Wounds in Aging, the project’s
interdisciplinary team plans to test an oral nutrient therapy containing the bioactive elements of fish oil to
stimulate healing and prevent recurrence of CVLUs. CVLU pathobiology involves venous hypertension and high
numbers of activated polymorphonuclear leukocytes (PMNs) in venous circulation and the ulcer
microenvironment, where they secrete excessive amounts of proteases that keep ulcers chronically inflamed.
Collective data from the team’s previous work support the organizing hypothesis that increasing intake of
eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) with oral supplementation will expedite CVLU
healing and prevent recurrence by raising levels of EPA+DHA-derived lipid mediators and lowering levels of
proinflammatory cytokines, thereby reducing PMN activation systemically and in ulcer microenvironments. The
collective outcomes are also expected to relieve CVLU-related pain and improve quality of life (QoL). The
randomized, double-blind study proposes to include 248 successive eligible adults ≥ 60 years of age with CVLUs
who continue to receive standard care at two university out-patient wound clinics. Participants will be randomized
to 2 groups: 12 weeks of daily oral therapy with EPA+DHA (2.5 g/d of EPA + 0.5 g/d of DHA) or daily oral therapy
with placebo. At 0, 4, 8 and 12 weeks, across the 2 groups, the team will pursue three specific aims: Aim 1.
Compare levels of EPA+DHA-derived lipid mediators, and inflammatory cytokines in blood and CVLU fluid;
Subaim 1a. Compare inflammatory cytokine gene expression by PMNs in blood; Aim 2. Compare PMN
activation in blood and CVLU fluid, and PMN-derived protease levels in CVLU fluid; Aim 3. Compare reduction
in wound area, controlling for factors known to affect healing, and determine relationships with lipid mediators,
cytokines and PMN activation. Subaim 3a. Compare frequency of CVLU recurrence and levels of study variables
in blood between 2 subgroups within the EPA+DHA group with healed CVLUs (after 3 additional months of
EPA+DHA therapy versus placebo therapy beyond Week 12). Subaim 3b. Compare the symptom of pain at all
time points and QoL at first and last time points across the 2 groups and 2 subgroups. The findings are expected
to lead to a new low-risk adjunct oral therapy to target and reduce excessive PMN activation in CVLU patients.
As such, the t...

## Key facts

- **NIH application ID:** 9906154
- **Project number:** 5R01AG059981-03
- **Recipient organization:** OHIO STATE UNIVERSITY
- **Principal Investigator:** Jodi Christine McDaniel
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $562,689
- **Award type:** 5
- **Project period:** 2018-09-30 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9906154

## Citation

> US National Institutes of Health, RePORTER application 9906154, Impact of Omega-3 Fatty Acid Oral Therapy on Healing of Chronic Venous Leg Ulcers in Older Adults (5R01AG059981-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9906154. Licensed CC0.

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