Venous Stasis Ulcers Clinical Trial
Official title:
Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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