Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers
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About
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.
Full description
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.
Enrollment
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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.
Trial design
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Interventional model
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41 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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