Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

October 14, 2015 updated by: Jodi McDaniel, Ohio State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University College of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EPA+DHA
EPA+DHA (fish oil)
Dietary supplement: Fish Oil
EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels
Placebo Comparator: Placebo
mineral oil
Dietary supplement: Fish Oil
EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid
Time Frame: 0, 28, 56 days
0, 28, 56 days

Secondary Outcome Measures

Outcome Measure
Time Frame
PMN counts and levels of PMN-derived proteases in CVLU wound fluid
Time Frame: 0, 28, 56 days
0, 28, 56 days

Other Outcome Measures

Outcome Measure
Time Frame
Re-epithelialization
Time Frame: 28, 56 days
28, 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Jodi C McDaniel, PhD, RN, The Ohio State University College of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 13, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011H0228
  • 1R21NR012803-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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