An interventional study of Fish Oil in Venous Stasis Ulcers, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-10-16.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
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.
378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's enrollment of 41 is below the median of 64 across 325 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
EPA+DHA (fish oil)
Dietary Supplement: Fish Oil
mineral oil
Dietary Supplement: Fish Oil
EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels
Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid
Time frame: 0, 28, 56 days
PMN counts and levels of PMN-derived proteases in CVLU wound fluid
Time frame: 0, 28, 56 days
Re-epithelialization
Time frame: 28, 56 days
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ohio State University