Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

Venous Stasis Ulcers Clinical Trial

Official title:

Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754506
• Other study ID #: 2011H0228
• Secondary ID: 1R21NR012803-01A
• Status: Completed
• Phase: N/A
• First received: December 13, 2012
• Last updated: October 14, 2015
• Start date: January 2013
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcers

Intervention

Dietary Supplement:
• Fish Oil
EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels

Locations

Country	Name	City	State
United States	The Ohio State University College of Nursing	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Re-epithelialization		28, 56 days	No
Primary	Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid		0, 28, 56 days	No
Secondary	PMN counts and levels of PMN-derived proteases in CVLU wound fluid		0, 28, 56 days	No