What side effects are associated with this type of intervention?

Common treatments for Chronic Venous Leg Ulcers (CVLUs) include omega-3 fatty acids, which can cause gastrointestinal issues such as diarrhea, nausea, and a fishy aftertaste. Compression therapy, another standard treatment, may lead to discomfort and skin irritation. Wound dressings can sometimes cause allergic reactions or infections if not properly managed. Systemic treatments like antibiotics can result in side effects ranging from mild gastrointestinal disturbances to severe allergic reactions.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Chronic Venous Leg Ulcers that directly involve fish oil bioactive components or similar nutrient-based anti-inflammatory therapies. Current FDA-approved treatments for CVLUs typically include compression therapy, wound dressings, and medications to manage infection and inflammation. The study of fish oil bioactive components aims to explore a novel approach by reducing chronic inflammation at wound sites, which could potentially complement existing treatments if proven effective.

What other types of research exist?

Promising novel alternatives to fish oil bioactive components for reducing chronic inflammation in CVLUs patients include: 1) Curcumin, which has demonstrated anti-inflammatory properties in various clinical studies; 2) Antioxidants such as Vitamin E, which have shown potential in reducing inflammation and promoting healing; 3) Omega-6 fatty acids, which have been studied for their role in managing inflammation; and 4) Acupuncture, which has shown some efficacy in managing symptoms of chronic conditions. Patients should discuss these options with their healthcare provider to determine the best course of treatment.

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Omega-3 Fatty Acid

Omega-3 Supplements for Leg Ulcers

N/A

Recruiting

Led By Jodi C McDaniel, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to read and understand English or Spanish

Women and men ≥ 55 years of age with a CVLU between the ankle and knee that has been present for at least 4 weeks, but not longer than 12 months, prescribed compression therapy with 1-4 layer bandaging

Must not have

Diabetes if HbA1c > 12% or ulcer complicated by cellulitis, exposed tendon or bone

Chemotherapy within 6 months of Week 0

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 12 weeks ((and at 3 month timepoint beyond week 12 in participants in extended study - with healed leg ulcers by week 12)

Summary

This trial tests if a pill with fish oil nutrients can help heal stubborn leg wounds in adults aged 55 and older. These wounds are hard to heal because of ongoing inflammation. The fish oil nutrients aim to reduce this inflammation, helping the wounds to heal better. Fish oil has been studied for its anti-inflammatory properties and potential benefits in wound healing.

Who is the study for?

This trial is for men and women aged 55 or older with chronic venous leg ulcers between the ankle and knee, present for 4 weeks to 12 months. Participants must have a wound area of 2-60 cm2, understand English or Spanish, have certain blood flow levels in their legs (ABPI of 0.7-1.2), be on prescribed compression therapy, and able to consent. Excluded are those taking certain anti-inflammatory drugs more than twice a week (except low-dose aspirin), with fish allergies, autoimmune diseases, poorly controlled diabetes or recent chemotherapy.

What is being tested?

The study tests if oral Omega-3 fatty acids (EPA+DHA from fish oil) can help heal chronic leg ulcers by reducing inflammation at the wound site compared to a placebo. The goal is to see if this nutrient intervention changes the healing environment of these wounds.

What are the potential side effects?

While not specified here, common side effects of Omega-3 supplements may include an upset stomach, nausea, diarrhea and fishy aftertaste; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can read and understand either English or Spanish.

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I am 55 or older with a leg ulcer between my ankle and knee, present for 1-12 months, and prescribed compression therapy.

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My wound is between 2 and 60 square centimeters in size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My diabetes is severe with HbA1c over 12% or I have a serious foot ulcer.

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I have not had chemotherapy in the last 6 months.

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I use corticosteroids, COX-2 inhibitors, or NSAIDs more than twice a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 4, 8 and 12 weeks (and at 3 month timepoint beyond week 12 in participants in extended study - with healed leg ulcers by week 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 4, 8 and 12 weeks (and at 3 month timepoint beyond week 12 in participants in extended study - with healed leg ulcers by week 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 4, 8 and 12 weeks (and at 3 month timepoint beyond week 12 in participants in extended study - with healed leg ulcers by week 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in EPA+DHA-derived lipid mediators

Change in PMN-derived proteases

Change in inflammatory cytokines

+2 more

Secondary study objectives

Change in symptom of pain

inflammatory cytokine gene expression

quality of life using the VEINES-QOL/Sym questionnaire

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EPA+DHA GroupExperimental Treatment1 Intervention

12 weeks of daily oral therapy with EPA+DHA (three opaque softgels to provide a total daily intake of 1.87 g of EPA + 1.0 g of DHA)

Group II: Placebo GroupPlacebo Group1 Intervention

12 weeks of daily oral therapy with placebo (three opaque softgels to provide a total daily intake of 2.5 mL of mineral oil)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EPA+DHA

2017

N/A

~50

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Venous Leg Ulcers (CVLUs) often focus on reducing chronic inflammation, which is a significant barrier to wound healing. Fish oil bioactive components, such as omega-3 fatty acids, are being studied for their anti-inflammatory properties. These components work by modulating inflammatory pathways, thereby reducing the chronic inflammation that can prevent ulcer healing. This is particularly important for CVLU patients, as reducing inflammation can improve the wound microenvironment, facilitating better healing and potentially reducing the duration and severity of ulcers.