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

NCT ID: NCT03576989

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2024-12-18

Brief Summary

The purpose of this study is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to promote healing of chronic venous leg ulcers (CVLUs) by reducing the chronic inflammation at wound sites that prevents healing progression. If this systemic, nutrient intervention is found to alter the microenvironment of CVLUs, the science of wound healing and care of patients with CVLUs will be vastly improved.

Detailed Description

The pathogenesis of CVLU involves high numbers of activated polymorphonuclear leukocytes (PMN) that are associated with persistent inflammation in the wound bed. The proposed research is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil (eicosapentaenoic acid - EPA + docosahexaenoic acid - DHA) to assuage PMN activity and promote healing. The study plans to include 248 successive eligible adults ≥ 55 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 (1.87 g/d of EPA + 1.0 g/d of DHA) or daily oral therapy with placebo. At 0, 4, 8 and 12 weeks, across the 2 groups, three specific aims will be pursued:

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 (neutrophils and monocytes).

Aim 2. Compare PMN activation (blood, CVLU fluid), and PMN-derived protease levels (CVLU fluid).

Aim 3. Compare reduction in wound area, controlling for key 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 time point).

Subaim 3b. Compare the symptom of pain at all time points and quality of life at first and last study visits across the 2 groups and 2 subgroups.

Conditions

Chronic Venous Leg Ulcers

Keywords

leg ulcer, fish oil, wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

EPA+DHA Group

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 Type: EXPERIMENTAL

EPA+DHA

Intervention Type: DIETARY_SUPPLEMENT

EPA+DHA are the n-3 polyunsaturated fatty acids contained in fish oil

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo contains mineral oil

Interventions

EPA+DHA

EPA+DHA are the n-3 polyunsaturated fatty acids contained in fish oil

Intervention Type: DIETARY_SUPPLEMENT

placebo

placebo contains mineral oil

Intervention Type: OTHER

Other Intervention Names

eicosapentaenoic acid + docosahexaenoic acid; fish oil; mineral oil

Eligibility Criteria

Inclusion Criteria

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;
• Ankle brachial pressure index (ABPI) between 0.7 and 1.2;
• Target wound area of 2-60 cm2 who can
• Read and understand English or Spanish, and
• Provide consent.

Exclusion Criteria

• Fish allergy;
• Corticosteroids or selective cyclooxygenase (COX)-2 inhibitors (e.g., Celebrex); non- steroidal anti-inflammatory drugs (NSAIDS) > 2x/week (exception: aspirin 81 mg/day);
• Autoimmune diseases;
• Chemotherapy within 6 months of Week 0;
• Diabetes if HbA1c > 12% or ulcer complicated by cellulitis, exposed tendon or bone.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jodi C McDaniel, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University, College of Nursing

Locations

The Ohio State University College of Nursing

Columbus, Ohio, United States

Countries

United States

References

McDaniel JC, Rausch J, Tan A. 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. 2020 Jan 16;21(1):93. doi: 10.1186/s13063-019-3970-7.

Reference Type: DERIVED

PMID: 31948466 (View on PubMed)

Other Identifiers

R01AG059981

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018H0261

Identifier Type: -

Identifier Source: org_study_id