Omega-3 Supplements for Leg Ulcers

Overseen By Sandra Solove, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Corticosteroids, COX-2 inhibitors, NSAIDs

Disqualifiers: Fish allergy, Autoimmune diseases, Diabetes, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

296 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for the trial?

You may need to stop certain medications. The trial excludes people taking corticosteroids, COX-2 inhibitors, and NSAIDs more than twice a week, except for aspirin 81 mg/day.

Will I have to stop taking my current medications?

The trial requires that you stop taking corticosteroids, COX-2 inhibitors, and NSAIDs more than twice a week, except for aspirin at 81 mg per day.

What data supports the idea that Omega-3 Supplements for Leg Ulcers is an effective treatment?

The available research shows that Omega-3 supplements, specifically EPA and DHA from fish oil, can be effective in treating leg ulcers. In a study, patients who took these supplements showed a significant reduction in wound size, with a 57% reduction by Day 28 and a 76% reduction by Day 56, compared to a 35% and 59% reduction in the control group. This suggests that Omega-3 supplements help reduce inflammation and promote healing in leg ulcers. Additionally, fish skin grafts containing Omega-3 have been shown to speed up healing and result in more fully healed wounds compared to standard treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Omega-3 Supplements for Leg Ulcers?

Research shows that omega-3 fatty acids, like those in fish oil, can help reduce inflammation and promote healing in chronic wounds, such as leg ulcers. In a study, patients taking EPA and DHA (components of fish oil) showed significant reductions in wound size and inflammation markers compared to those who did not receive the treatment. ^{1 2 3 4 5}

What safety data exists for omega-3 supplements in treating leg ulcers?

The studies reviewed indicate that omega-3 fatty acids, specifically EPA and DHA from fish oil, have been tested for their effects on chronic venous leg ulcers and other chronic wounds. These studies suggest that omega-3 supplements can reduce inflammation and promote wound healing without reporting significant adverse effects. However, specific safety data or adverse events related to omega-3 supplementation in these trials are not detailed in the provided abstracts. ^{1 2 3 4 5}

Is it safe to use omega-3 supplements for leg ulcers?

Omega-3 supplements, like those found in fish oil, are generally considered safe for humans and have been used in various studies to help with wound healing, including leg ulcers. They have anti-inflammatory properties and can aid in reducing inflammation, which is beneficial for healing chronic wounds. ^{1 2 3 4 5}

Is the treatment EPA+DHA a promising treatment for leg ulcers?

Yes, EPA+DHA, which are components of fish oil, show promise as a treatment for leg ulcers. Studies indicate that they help reduce inflammation and promote healing by decreasing harmful cell activity in the wound area, leading to significant reductions in wound size. ^{1 3 4 6 7}

How is the treatment with omega-3 supplements for leg ulcers different from other treatments?

Omega-3 supplements, containing EPA and DHA from fish oil, are unique because they are taken orally and work by reducing inflammation in the wound area, which helps heal chronic venous leg ulcers more effectively than standard topical treatments that often only provide short-term relief. ^{1 3 4 6 7}

Research Team

Jodi C McDaniel, PhD, RN

Principal Investigator

Ohio State University, College of Nursing

Eligibility Criteria

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.

Inclusion Criteria

Ability to provide consent

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

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

Exclusion Criteria

You are allergic to fish.

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

I have not had chemotherapy in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of daily oral therapy with either EPA+DHA or placebo

12 weeks

Visits at 0, 4, 8, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including recurrence of ulcers and quality of life

3 months

1 visit (in-person) at 3 months post-treatment

Open-label extension (optional)

Participants with healed leg ulcers by Week 12 may continue with EPA+DHA therapy for an additional 3 months

3 months

Treatment Details

Interventions

• EPA+DHA
• placebo

Trial Overview 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.

Participant Groups

Group I: EPA+DHA Group Experimental Treatment 1 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 Group Placebo Group 1 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)

EPA+DHA is already approved in United States, European Union for the following indications:

Approved in United States as Fish Oil for:

• Dietary Supplement

Approved in European Union as Fish Oil for:

• Dietary Supplement

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

This trial is testing an oral therapy with fish oil components (EPA and DHA) on 248 adults aged 55 and older with chronic venous leg ulcers (CVLUs) to see if it can reduce inflammation and promote healing over 12 weeks.

If successful, this therapy could provide a new treatment option for CVLUs by targeting excessive activation of immune cells that keep these wounds in a chronic state, potentially improving healing outcomes and quality of life for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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, JC., Rausch, J., Tan, A.[2020]

In a 12-week study involving 60 subjects with diabetic foot ulcers, supplementation with 1000mg of omega-3 fatty acids from flaxseed oil significantly reduced ulcer size compared to a placebo, indicating improved wound healing.

The omega-3 supplementation also led to notable improvements in metabolic markers, including decreased insulin levels and insulin resistance, as well as increased antioxidant capacity, suggesting that it may enhance healing indirectly through better metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and metabolic response to flaxseed oil omega-3 fatty acids supplementation in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial. Soleimani, Z., Hashemdokht, F., Bahmani, F., et al.[2022]

In a study involving 40 critically ill patients with pressure ulcers, those who received a fish oil- and micronutrient-enriched formula showed significant improvements in immune function, indicated by increased levels of specific adhesion molecules on immune cells.

Patients on the study formula did not experience worsening of their pressure ulcers over time, while the control group did, suggesting that the enriched formula may help prevent the deterioration of pressure ulcers through its effects on immune response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral n-3 fatty acids and micronutrients enhance percentage of positive neutrophil and lymphocyte adhesion molecules: a potential mediator of pressure ulcer healing in critically ill patients. Theilla, M., Schwartz, B., Zimra, Y., et al.[2012]

Oral therapy with EPA and DHA significantly reduced activated polymorphonuclear leukocytes (PMNs) in chronic venous leg ulcers (CVLUs), indicating a potential mechanism for enhancing healing by modulating inflammation.

Patients receiving EPA and DHA showed greater reductions in wound area (76% by Day 56) compared to the placebo group (59%), suggesting that these bioactive components can improve healing outcomes when added to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EPA + DHA supplementation reduces PMN activation in microenvironment of chronic venous leg ulcers: A randomized, double-blind, controlled study. McDaniel, JC., Szalacha, L., Sales, M., et al.[2022]

Acellular fish skin grafts from Atlantic cod, rich in omega-3 fatty acids like EPA and DHA, have shown increased efficacy in treating chronic, non-healing wounds such as diabetic foot ulcers, leading to faster healing rates compared to standard treatments.

The unique lipid profile of fish skin grafts not only promotes wound closure but also provides barrier protection against bacteria and modulates the inflammatory response, enhancing overall wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fish Skin Grafts with Omega-3 for Treatment of Chronic Wounds: Exploring the Role of Omega-3 Fatty Acids in Wound Healing and A Review of Clinical Healing Outcomes. Seth, N., Chopra, D., Lev-Tov, H.[2022]

Omega-3-acid ethyl esters were found to be highly effective in treating refractory pressure ulcers and stasis dermatitis, as demonstrated in two case studies involving a 21-year-old female and a 76-year-old male, with complete healing observed in 10 and 12 weeks respectively.

This report suggests that oral administration of omega-3-acid ethyl esters could be a promising alternative treatment for patients who do not respond to traditional topical therapies for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New therapy using omega-3-Acid ethyl esters for decubitus ulcers and stasis dermatitis: a case report. Nagai, K., Matsumaru, K., Hirai, I., et al.[2020]

Older adults with chronic venous leg ulcers (CVLUs) consumed significantly lower levels of vitamin C and higher levels of sodium, sugar, and saturated fat compared to recommended dietary allowances, which may negatively impact their wound healing.

The study suggests that a multidisciplinary approach, including regular dietary assessments and personalized dietary interventions, could enhance wound healing and overall health in this population of older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional profile of older adults with chronic venous leg ulcers: a pilot study. McDaniel, JC., Kemmner, KG., Rusnak, S.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical and metabolic response to flaxseed oil omega-3 fatty acids supplementation in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Enteral n-3 fatty acids and micronutrients enhance percentage of positive neutrophil and lymphocyte adhesion molecules: a potential mediator of pressure ulcer healing in critically ill patients. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

EPA + DHA supplementation reduces PMN activation in microenvironment of chronic venous leg ulcers: A randomized, double-blind, controlled study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Fish Skin Grafts with Omega-3 for Treatment of Chronic Wounds: Exploring the Role of Omega-3 Fatty Acids in Wound Healing and A Review of Clinical Healing Outcomes. [2022]

6. Estonia pubmed.ncbi.nlm.nih.gov

New therapy using omega-3-Acid ethyl esters for decubitus ulcers and stasis dermatitis: a case report. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Nutritional profile of older adults with chronic venous leg ulcers: a pilot study. [2018]