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

  • STATUS
    Recruiting
  • End date
    Oct 16, 2024
  • participants needed
    248
  • sponsor
    Ohio State University
Updated on 16 March 2021

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.

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.

Details
Condition Chronic Venous Leg Ulcers
Treatment Placebo, EPA+DHA
Clinical Study IdentifierNCT03576989
SponsorOhio State University
Last Modified on16 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 60 yrs?
Gender: Male or Female
Do you have Chronic Venous Leg Ulcers?
Is your age greater than or equal to 55 yrs?
Do you have any of these conditions: Do you have Chronic Venous Leg Ulcers??
Is your age greater than or equal to 55 yrs?
Do you have any of these conditions: Do you have Chronic Venous Leg Ulcers??
Is your age greater than or equal to 55 yrs?
Do you have any of these conditions: Do you have Chronic Venous Leg Ulcers??
Is your age greater than or equal to 55 yrs?
Do you have any of these conditions: Do you have Chronic Venous Leg Ulcers??
Is your age greater than or equal to 55 yrs?
Do you have any of these conditions: Do you have Chronic Venous Leg Ulcers??
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); nonsteroidal 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
Clear my responses

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