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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

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)

Awards & highlights

Study Summary

This trial will test whether a fish oil supplement can help heal chronic venous leg ulcers by reducing inflammation. If successful, this could improve the science of 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.Check my eligibility

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.See study design

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

Select...

I can read and understand either English or Spanish.

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in EPA+DHA-derived lipid mediators

Change in PMN-derived proteases

Change in inflammatory cytokines

+2 more

Secondary outcome measures

Change in symptom of pain

inflammatory cytokine gene expression

quality of life using the VEINES-QOL/Sym questionnaire

+1 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02256969

Eye Pain

100%

80%

60%

40%

20%

Study treatment Arm

Meibomian Gland Probing Plus Lubricant

Sham Meibomian Gland Probing Plus Lubricant

Meibomian Gland Probing Plus Blephamide

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

829 Previous Clinical Trials

505,495 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,016,815 Total Patients Enrolled

Jodi C McDaniel, PhDPrincipal InvestigatorOhio State University, College of Nursing

Media Library

Chronic Venous Leg Ulcers Clinical Trial 2023: EPA+DHA Highlights & Side Effects. Trial Name: NCT03576989 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there open slots in this experiment that patients can join?

"According to information on clinicaltrials.gov, the medical trial is currently seeking suitable participants. It was first announced in April 2019 and has been updated most recently at the end of March 2022."

Answered by AI

What is the cap for participants in this research project?

"Affirmative. According to information hosted on clinicaltrials.gov, this trial is actively recruiting participants as of March 29th 2022. The study was first posted back in April 15th 2019 and requires 248 volunteers from a single medical centre."

Answered by AI

What end-goal is this clinical experiment aiming to accomplish?

"Over a period of three months, this clinical trial will be assessing the progress in wound area reduction. Moreover, secondary outcomes include inflammatory cytokine gene expression from neutrophils and monocytes within blood samples, recurrence rate of chronic venous leg ulcers after healing is attained, as well as quality of life evaluation through the VEINES-QOL/Sym questionnaire."

Answered by AI

Recent research and studies

TrialsJournal

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

McDaniel, Jodi C., Jamie Rausch, and Alai Tan. 2020. “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”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-019-3970-7.

clinicaltrials.govStudy

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

2019. "Impact of Omega-3 Fatty Acid Oral Therapy on Healing of Chronic Venous Leg Ulcers in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03576989.