Impact of Omega-3 Fatty Acid Oral Therapy on Healing of Chronic Venous Leg Ulcers in Older Adults

NCT03576989 | Completed DMC

• 2 other identifiers: 2018H0261R01AG059981
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 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 (CVLUs) by reducing the chronic inflammation at wound sites that prevents healing progression. If this systemic, nutrient intervention is found to alter the microenvironment of CVLUs, the science of wound healing and care of patients with CVLUs will be vastly improved.

Conditions

Chronic Venous Leg Ulcers

Keywords

leg ulcer, fish oil, wounds

Outcome Measures

Primary Outcomes (5)

• Change in EPA+DHA-derived lipid mediators

  plasma and wound fluid levels of EPA+DHA-derived lipid mediators of inflammation

  0, 4, 8 and 12 weeks

• Change in inflammatory cytokines

  plasma and wound fluid levels of pro- and anti-inflammatory cytokines

  0, 4, 8 and 12 weeks

• Change in polymorphonuclear leukocyte (PMN) activation

  blood and wound fluid levels of PMN activation

  0, 4, 8 and 12 weeks

• Change in PMN-derived proteases

  wound fluid levels of PMN-derived proteases

  0, 4, 8 and 12 weeks

• Change in reduction in wound area

  reduction in wound area measured in cm2

  0, 4, 8 and 12 weeks

Secondary Outcomes (4)

• inflammatory cytokine gene expression

  0, 4, 8 and 12 weeks

• recurrence of chronic venous leg ulcers

  3 months beyond Week 12 time point in participants whose leg ulcers have healed by Week 12

• Change in symptom of pain

  0, 4, 8 and 12 weeks (and at 3 month timepoint beyond Week 12 in participants in extended study - with healed leg ulcers by Week 12)

• quality of life using the VEINES-QOL/Sym questionnaire

  0, 12 weeks ((and at 3 month timepoint beyond Week 12 in participants in extended study - with healed leg ulcers by Week 12)

Study Arms (2)

EPA+DHA Group

EXPERIMENTAL

12 weeks of daily oral therapy with EPA+DHA (three opaque softgels to provide a total daily intake of 1.87 g of EPA + 1.0 g of DHA)

Dietary Supplement: EPA+DHA

Placebo Group

PLACEBO COMPARATOR

12 weeks of daily oral therapy with placebo (three opaque softgels to provide a total daily intake of 2.5 mL of mineral oil)

Other: placebo

Interventions

EPA+DHA DIETARY_SUPPLEMENT

EPA+DHA are the n-3 polyunsaturated fatty acids contained in fish oil

Also known as: eicosapentaenoic acid + docosahexaenoic acid, fish oil

EPA+DHA Group

placebo OTHER

placebo contains mineral oil

Also known as: mineral oil

Placebo Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men ≥ 55 years of age with:
• A CVLU between the ankle and knee that has been present for at least 4 weeks, but not longer than 12 months, prescribed compression therapy with 1-4 layer bandaging;
• Ankle brachial pressure index (ABPI) between 0.7 and 1.2;
• Target wound area of 2-60 cm2 who can
• Read and understand English or Spanish, and
• Provide consent.

You may not qualify if:

• Fish allergy;
• Corticosteroids or selective cyclooxygenase (COX)-2 inhibitors (e.g., Celebrex); non- steroidal anti-inflammatory drugs (NSAIDS) \> 2x/week (exception: aspirin 81 mg/day);
• Autoimmune diseases;
• Chemotherapy within 6 months of Week 0;
• Diabetes if HbA1c \> 12% or ulcer complicated by cellulitis, exposed tendon or bone.

Sponsors & Collaborators

• Ohio State University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• McDaniel JC, Rausch J, Tan A. Impact of omega-3 fatty acid oral therapy on healing of chronic venous leg ulcers in older adults: Study protocol for a randomized controlled single-center trial. Trials. 2020 Jan 16;21(1):93. doi: 10.1186/s13063-019-3970-7.

  PMID: 31948466 DERIVED

MeSH Terms

Conditions

Leg Ulcer; Wounds and Injuries

Interventions

Eicosapentaenoic Acid; Docosahexaenoic Acids; Fish Oils; Mineral Oil

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Petrolatum; Hydrocarbons; Organic Chemicals

Study Officials

• Jodi C McDaniel, PhD

  Ohio State University, College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Investigators, participants and care providers blinded as to treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2-group randomized, double-blind, repeated measures design

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 5, 2018
• Study Start: April 15, 2019
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)