Venous Stasis Ulcers
Conditions
Keywords
leg ulcers, wounds, fish oil, lipid mediators, chronic venous stasis ulcers
Brief 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 (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
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.
Interventions
DIETARY_SUPPLEMENTFish Oil
EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels
Sponsors
National Institute of Nursing Research (NINR)
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| PMN counts and levels of PMN-derived proteases in CVLU wound fluid | 0, 28, 56 days |
Other
| Measure | Time frame |
|---|---|
| Re-epithelialization | 28, 56 days |
Countries
United States
Outcome results
None listed