Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

Study Overview
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Brief Summary
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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 (CVLU). If this systemic, nutrient intervention is found to alter the microenvironment of CVLU, the science of wound healing and care of patients with CVLU will be vastly improved.

Detailed Description
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The pathogenesis of CVLU involves high numbers of activated polymorphonuclear leukocytes (PMN) that are associated with persistent inflammation in the wound bed 5-9. We propose to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to assuage PMN activity and promote healing of CVLU. If this systemic, nutrient intervention is found to alter the microenvironment of CVLU, the science of wound healing and care of patients with CVLU will be vastly improved. The purpose of this study is to test three fundamental corollaries of our organizing hypothesis in a 2-group, double-blind, randomized, experimental design on CVLU patients. The findings from the proposed experiments will increase our understanding of lipid mediators that influence wound healing and PMN function, and may lead to an innovative approach to reduce the physical and emotional burdens of nonhealing or recurrent CVLU.

Official Title
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Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

Conditions
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Venous Stasis Ulcers

Intervention / Treatment
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* Dietary Supplement: Fish Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women ages 18-85 years having at least one existing CVLU between the ankle and knee for ≥ 3 months medical clearance to take 81mg/d of aspirin prescribed compression therapy; ambulatory ankle brachial pressure index (ABPI) of ≥ 0.8 target wound of ≥ 1 x 1 inches (6.25 cm2) can understand English and sign own consent Exclusion Criteria: allergy to fish or seafood exposed bone, tendon or fascia around target wound receiving warfarin or Plavix therapy immunologic related condition (e.g. Crohn's disease, systemic lupus erythematosus) chronic inflammatory skin diseases (e.g. pyoderma gangrenosum, psoriasis) requiring non-steroidal anti-inflammatory drugs > 2x a week nutritional supplements or corticosteroids chronic renal insufficiency already in a study related to CVLU.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPA+DHA<br>EPA+DHA (fish oil) | Dietary Supplement: Fish Oil<br>* EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels<br>|
| Placebo Comparator: Placebo<br>mineral oil | Dietary Supplement: Fish Oil<br>* EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid |  | 0, 28, 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PMN counts and levels of PMN-derived proteases in CVLU wound fluid |  | 0, 28, 56 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leg ulcers, wounds, fish oil, lipid mediators, chronic venous stasis ulcers