Testing Fish Oil Derivatives In Healing Of Chronic Venous... | NCT01754506

Studies
Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

NCT01754506

Sponsor

Ohio State University

Status

Completed

Last Update Posted

Oct 16, 2015Estimated

Enrollment

41Actual

Phase

Not Applicable

Conditions

Venous Stasis Ulcers

Interventions

Fish Oil

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R21NR012803-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Dec 13, 2012

First Submission Date that Met QC Criteria

Dec 18, 2012

First Posted Date

Dec 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2015

Last Update Posted Date

Oct 16, 2015Estimated

Name	Class
National Institute of Nursing Research (NINR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EPA+DHA	Experimental	EPA+DHA (fish oil)	Dietary Supplement: Fish Oil
Placebo	Placebo Comparator	mineral oil	Dietary Supplement: Fish Oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fish Oil	Dietary Supplement	EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels	EPA+DHA Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid		0, 28, 56 days

Secondary Outcomes

Measure	Description	Time Frame
PMN counts and levels of PMN-derived proteases in CVLU wound fluid		0, 28, 56 days

Other Outcomes

Measure	Description	Time Frame
Re-epithelialization		28, 56 days

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jodi C McDaniel, PhD, RN	The Ohio State University College of Nursing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University College of Nursing		Columbus	Ohio	43210	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32319144	Derived	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.

ID	Term
D014647	Varicose Ulcer
D007871	Leg Ulcer
D014947	Wounds and Injuries

ID	Term
D014648	Varicose Veins
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012883	Skin Ulcer

ID	Term
D009821	Oils
D008055	Lipids