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Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01754506
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : October 16, 2015
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Jodi McDaniel, Ohio State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Venous Stasis Ulcers Dietary Supplement: Fish Oil Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers
Study Start Date : January 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arms and Interventions
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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


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

Secondary Outcome Measures :
  1. PMN counts and levels of PMN-derived proteases in CVLU wound fluid [ Time Frame: 0, 28, 56 days ]

Other Outcome Measures:
  1. Re-epithelialization [ Time Frame: 28, 56 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754506


Locations
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United States, Ohio
The Ohio State University College of Nursing
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Jodi C McDaniel, PhD, RN The Ohio State University College of Nursing
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jodi McDaniel, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01754506    
Other Study ID Numbers: 2011H0228
1R21NR012803-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Keywords provided by Jodi McDaniel, Ohio State University:
leg ulcers
wounds
fish oil
lipid mediators
chronic venous stasis ulcers
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
 Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases