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Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

Primary Purpose

Venous Stasis Ulcers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fish Oil
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Stasis Ulcers focused on measuring leg ulcers, wounds, fish oil, lipid mediators, chronic venous stasis ulcers

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ohio State University College of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EPA+DHA

Placebo

Arm Description

EPA+DHA (fish oil)

mineral oil

Outcomes

Primary Outcome Measures

Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid

Secondary Outcome Measures

PMN counts and levels of PMN-derived proteases in CVLU wound fluid

Full Information

First Posted
December 13, 2012
Last Updated
October 14, 2015
Sponsor
Ohio State University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01754506
Brief Title
Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers
Official Title
Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Stasis Ulcers
Keywords
leg ulcers, wounds, fish oil, lipid mediators, chronic venous stasis ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPA+DHA
Arm Type
Experimental
Arm Description
EPA+DHA (fish oil)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
mineral oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil
Intervention Description
EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
PMN counts and levels of PMN-derived proteases in CVLU wound fluid
Time Frame
0, 28, 56 days
Other Pre-specified Outcome Measures:
Title
Re-epithelialization
Time Frame
28, 56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jodi C McDaniel, PhD, RN
Organizational Affiliation
The Ohio State University College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University College of Nursing
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32319144
Citation
McDaniel JC. Dietary supplement use by older adults with chronic venous leg ulcers: A retrospective, descriptive study. Wound Repair Regen. 2020 Jul;28(4):561-572. doi: 10.1111/wrr.12821. Epub 2020 May 4.
Results Reference
derived

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Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

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