Venous Stasis UlcersNCT01754506
Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers
A study testing Fish Oil in people with Venous Stasis Ulcers, run by Ohio State University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Venous Stasis Ulcers
- What is being tested?
- Fish Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- nutritional supplements or corticosteroids
- chronic renal insufficiency
- already in a study related to CVLU.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Nursing
Columbus, Ohio, 43210
About this study
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.
Read the 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.
- Conditions
- Venous Stasis Ulcers
- Being tested
- Fish Oil
- Keywords
- leg ulcers, wounds, fish oil, lipid mediators, chronic venous stasis ulcers
- Medical subject headings
- Varicose Ulcer, Leg Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels
| Study group | Role | What they receive |
|---|---|---|
| EPA+DHA | Experimental | EPA+DHA (fish oil) Receives: Dietary Supplement: Fish Oil |
| Placebo | Placebo comparator | mineral oil Receives: Dietary Supplement: Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid
Measured: 0, 28, 56 days
Secondary outcomes (1)
PMN counts and levels of PMN-derived proteases in CVLU wound fluid
Measured: 0, 28, 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Stasis UlcersStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Jodi McDaniel, Ohio State University
- Investigators
- Jodi C McDaniel, PhD, RN, Principal investigator, The Ohio State University College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754506
- Sponsor's protocol ID
- 2011H0228
- Other IDs
- 1R21NR012803-01A1
- Status last verified
- Oct 2015
- First submitted
- 13 Dec 2012
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32319144
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT01754506
- Acronym / sponsor ID
- 2011H0228
- Conditions
- Venous Stasis Ulcers
- Keywords
- leg ulcers, wounds, fish oil, lipid mediators, chronic venous stasis ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPA+DHA | Experimental | Dietary Supplement: Fish OilEPA+DHA (fish oil) |
| Placebo | Placebo comparator | Dietary Supplement: Fish Oilmineral oil |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish OilEPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels | Dietary supplement | EPA+DHA, Placebo |
Primary outcome
Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid
Time frame: 0, 28, 56 days
1 secondary outcome
PMN counts and levels of PMN-derived proteases in CVLU wound fluid
Time frame: 0, 28, 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Derived from this study: PubMed 32319144McDaniel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jodi C McDaniel, PhD, RN principal investigator
The Ohio State University College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil in people with Venous Stasis Ulcers, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid (time frame: 0, 28, 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01754506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.