Clinical trial NCT01754506: 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
Overall status: COMPLETED
Phase: NA
Conditions: Venous Stasis Ulcers
Keywords: leg ulcers
wounds
fish oil
lipid mediators
chronic venous stasis ulcers
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2012-12-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid
timeFrame: 0, 28, 56 days
Secondary outcomes:
measure: PMN counts and levels of PMN-derived proteases in CVLU wound fluid
timeFrame: 0, 28, 56 days
Other outcomes:
measure: Re-epithelialization
timeFrame: 28, 56 days
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Nursing
state: Ohio
Study officials:
affiliation: The Ohio State University College of Nursing
name: Jodi C McDaniel, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.