Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers
2 other identifiers
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2012
CompletedFirst Posted
Study publicly available on registry
December 21, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 16, 2015
October 1, 2015
2.5 years
December 13, 2012
October 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid
0, 28, 56 days
Secondary Outcomes (1)
PMN counts and levels of PMN-derived proteases in CVLU wound fluid
0, 28, 56 days
Other Outcomes (1)
Re-epithelialization
28, 56 days
Study Arms (2)
EPA+DHA
EXPERIMENTALEPA+DHA (fish oil)
Placebo
PLACEBO COMPARATORmineral oil
Interventions
EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University College of Nursing
Columbus, Ohio, 43210, United States
Related Publications (1)
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.
PMID: 32319144DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jodi C McDaniel, PhD, RN
The Ohio State University College of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 13, 2012
First Posted
December 21, 2012
Study Start
January 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
October 16, 2015
Record last verified: 2015-10