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Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

This study is currently recruiting participants.
Verified May 2013 by Ohio State University
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Jodi McDaniel, Ohio State University
ClinicalTrials.gov Identifier:
NCT01754506
First received: December 13, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Venous Stasis Ulcers
 Dietary Supplement: Fish Oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

Resource links provided by NLM:

Drug Information available for: Fish oil
U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in CVLU wound fluid [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PMN counts and levels of PMN-derived proteases in CVLU wound fluid [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Increases in re-epithelialization [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754506

Contacts
Contact: Jodi C McDaniel, PhD, RN 614-292-1345 jmcdaniel@con.ohio-state.edu
Contact: Paula S Smailes, MSN, RN 614-292-0151 psmailes@con.ohio-state.edu

Locations
United States, Ohio
The Ohio State University College of Nursing Recruiting
Columbus, Ohio, United States, 43210
Contact: Paula S Smailes, MSN, RN     614-292-0151     psmailes@con.ohio-state.edu    
Principal Investigator: Jodi C McDaniel, PhD, RN            
Sponsors and Collaborators
Ohio State University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Jodi C McDaniel, PhD, RN The Ohio State University College of Nursing
  More Information

No publications provided

Responsible Party: Jodi McDaniel, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01754506     History of Changes
Other Study ID Numbers: 2011H0228, 1R21NR012803-01A1
Study First Received: December 13, 2012
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
leg ulcers
wounds
fish oil
lipid mediators
chronic venous stasis ulcers

Additional relevant MeSH terms:
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Ulcer
 Skin Ulcer
Phlebitis
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Varicose Veins
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013