Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

Not Applicable

Completed

• Conditions: Venous Stasis Ulcers
• Interventions: Dietary Supplement: Fish Oil

• Registration Number: NCT01754506
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Study Start: 2013-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPA+DHA	Fish Oil	EPA+DHA (fish oil)
Placebo	Fish Oil	mineral oil

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
PMN counts and levels of PMN-derived proteases in CVLU wound fluid	0, 28, 56 days

Trial Locations

Locations (1)

The Ohio State University College of Nursing; 🇺🇸 Columbus, Ohio, United States