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

Intervention Effects on Plasma Levels of Lipid Mediator of Inflammation HEPE5

时间窗: 0, 4, 8 and 12 weeks

Intervention effects on plasma levels of lipid mediator of inflammation HEPE5 measured in pg/mL at Weeks 4, 8 and 12. 5-HEPE (5-hydroxy-eicosapentaenoic acid) is an eicosanoid derived from eicosapentaenoic acid (EPA) via the 5-lipoxygenase pathway. It functions as an anti-inflammatory lipid mediator, in part through the generation of reactive oxygen species. Plasma levels of 5-HEPE (also known as HEPE5) were measured using liquid chromatography-mass spectrometry.

Intervention Effects on Plasma Levels of Lipid Mediator of Inflammation HEPE11

时间窗: 0, 4, 8 and 12 weeks

Intervention effects on plasma levels of lipid mediator of inflammation HEPE11 measured in pg/mL at Weeks 4, 8 and 12. 11-HEPE (11-hydroxy-5Z,8Z,12E,14Z,17Z-eicosapentaenoic acid) is a monohydroxy fatty acid derived from eicosapentaenoic acid (EPA). In research, it is commonly studied as a lipid mediator (eicosanoid) associated with anti-inflammatory processes. Plasma levels of 11-HEPE (also known as HEPE11) were quantified using liquid chromatography-mass spectrometry.

Intervention Effects on Plasma Levels of Lipid Mediator of Inflammation HEPE12

时间窗: 0, 4, 8 and 12 weeks

Intervention effects on plasma levels of lipid mediator of inflammation HEPE12 at Weeks 4, 8 and 12. 12-HEPE (12-hydroxyeicosapentaenoic acid) is an omega-3 fatty acid metabolite formed from eicosapentaenoic acid (EPA) via the 12-lipoxygenase pathway. It functions as a signaling lipid that helps mediate the beneficial effects of EPA and exhibits potent anti-inflammatory properties. Plasma levels of 12-HEPE (HEPE12) were quantified using liquid chromatography-mass spectrometry.

Intervention Effects on Plasma Levels of Lipid Mediator of Inflammation HEPE15

时间窗: 0, 4, 8 and 12 weeks

Intervention effects on plasma levels of lipid mediator of inflammation HEPE15 measured in pg/mL at Weeks 4, 8 and 12. 15-HEPE (15-hydroxyeicosapentaenoic acid) is an anti-inflammatory metabolite produced from the omega-3 fatty acid eicosapentaenoic acid (EPA) via the 15-lipoxygenase pathway. It functions as a pro-resolving lipid mediator, contributing to the resolution of inflammation. Plasma levels of 15-HEPE (HEPE15) were quantified using liquid chromatography-mass spectrometry.

Intervention Effects on Plasma Levels of Lipid Mediator of Inflammation HEPE18

时间窗: 0, 4, 8 and 12 weeks

Intervention effects on plasma levels of lipid mediator of inflammation HEPE18 measured in pg/mL at Weeks 4, 8 and 12. 18-HEPE (18-hydroxyeicosapentaenoic acid) is an anti-inflammatory metabolite of the omega-3 fatty acid eicosapentaenoic acid (EPA) and serves as a precursor for E-series resolvins. E-series resolvins actively terminate inflammatory responses, promote the resolution of inflammation, and support tissue repair. They exert potent anti-inflammatory effects by limiting neutrophil infiltration and suppressing pro-inflammatory cytokine production. Plasma levels of 18-HEPE (HEPE18) were quantified using liquid chromatography-mass spectrometry.

Comparison of Intervention and Control Groups in IL-1β Levels (Log pg/mL)

时间窗: 0, 4, 8 and 12 weeks

Plasma levels of IL-1β were quantified using a commercially available V-PLEX Human Biomarker Plex Kit (Meso Scale Diagnostics). Reported values reflect the group plasma IL-1β levels expressed as log-transformed concentrations (pg/mL). The IL-1β data are presented on a logarithmic (log) scale to normalize the distribution of cytokine concentrations, which are typically right-skewed. Because log-transformed values are used, negative means can occur when the original (raw) cytokine concentrations are less than 1 (in the units of measurement, pg/mL). Thus, the negative values at baseline do not indicate 'negative' cytokine levels, but rather low concentrations on the original scale. Across time points, less negative (i.e., higher) log values indicate higher cytokine concentrations, whereas more negative values indicate lower concentrations. Therefore, changes in the mean log values over time reflect relative increases or decreases in IL-1β levels.

Comparison of Intervention and Control Groups in IL-6 Levels (Log pg/mL)

时间窗: 0, 4, 8 and 12 weeks

Plasma levels of IL-6 were quantified using a commercially available V-PLEX Human Biomarker Plex Kit (Meso Scale Diagnostics). Reported values reflect the group plasma IL-6 levels expressed as log-transformed concentrations (pg/mL). The data are presented on a logarithmic (log) scale to normalize the distribution of cytokine concentrations, which are typically right-skewed. Because log-transformed values are used, negative means can occur when the original (raw) cytokine concentrations are less than 1 (in the units of measurement, pg/mL). Thus, the negative values at baseline do not indicate 'negative' cytokine levels, but rather low concentrations on the original scale. Across time points, less negative (i.e., higher) log values indicate higher cytokine concentrations, whereas more negative values indicate lower concentrations. Therefore, changes in the mean log values over time reflect relative increases or decreases in IL-6 levels.

1. Comparison of Intervention and Control Groups in TNF-α Levels (Log pg/mL)

时间窗: 0, 4, 8 and 12 weeks

Plasma levels of TNF-α were quantified using a commercially available V-PLEX Human Biomarker Plex Kit (Meso Scale Diagnostics). Reported values reflect the group plasma TNF-α levels expressed as log-transformed concentrations (pg/mL). The data are presented on a logarithmic (log) scale to normalize the distribution of cytokine concentrations, which are typically right-skewed. Because log-transformed values are used, negative means can occur when the original (raw) cytokine concentrations are less than 1 (in the units of measurement, pg/mL). Thus, the negative values at baseline do not indicate 'negative' cytokine levels, but rather low concentrations on the original scale. Across time points, less negative (i.e., higher) log values indicate higher cytokine concentrations, whereas more negative values indicate lower concentrations. Therefore, changes in the mean log values over time reflect relative increases or decreases in TNF-α levels.

Comparison of Intervention and Control Groups in IFN-γ Levels (Log pg/mL)

时间窗: 0, 4, 8 and 12 weeks

Plasma levels of IFN-γ were quantified using a commercially available V-PLEX Human Biomarker Plex Kit (Meso Scale Diagnostics). Reported values reflect the group plasma IFN-γ levels expressed as log-transformed concentrations (pg/mL). The data are presented on a logarithmic (log) scale to normalize the distribution of cytokine concentrations, which are typically right-skewed. Because log-transformed values are used, negative means can occur when the original (raw) cytokine concentrations are less than 1 (in the units of measurement, pg/mL). Thus, the negative values at baseline do not indicate 'negative' cytokine levels, but rather low concentrations on the original scale. Across time points, less negative (i.e., higher) log values indicate higher cytokine concentrations, whereas more negative values indicate lower concentrations. Therefore, changes in the mean log values over time reflect relative increases or decreases in IFN-γ levels.

Intervention Effects on Polymorphonuclear Leukocyte (PMN) Activation (Log Cells/µL)

时间窗: 0, 4, 8 and 12 weeks

Reported values reflect PMN activation in plasma, expressed as log-transformed concentrations (cells/µL) at Weeks 4, 8, and 12.

Intervention Effects on Polymorphonuclear Leukocyte (PMN) - Derived Matrix Metalloproteinase-8 (MMP-8) Levels (Log pg/mg) in Wound Fluid

时间窗: 0, 4, 8 and 12 weeks

MMP-8, also known as neutrophil collagenase, is an enzyme that degrades collagen types I, II, and III and contributes to tissue remodeling and inflammatory processes. Wound fluid levels of MMP-8 were quantified using the MMP-8, neutrophil collagenase, Biotrak enzyme-linked immunosorbent assay kit (GE Healthcare Bio-Sciences Corp., Piscataway,NJ). Reported values reflect wound fluid MMP-8 levels, expressed as log-transformed concentrations (pg/mg) at Weeks 0, 4, 8, and 12.

Intervention Effects on Polymorphonuclear Leukocyte (PMN) - Derived Human Neutrophil Elastase (HNE, ELA2) Levels (Log pg/mg) in Wound Fluid

时间窗: 0, 4, 8 and 12 weeks

HNE is a potent serine protease stored in neutrophil granules that plays a key role in degrading bacteria and host tissue during inflammatory responses. Wound fluid levels of HNE were quantified using the InnuozymeTM Human Neutrophil Elastase Immunocapture Activity Assay Kit (Calbiochem, EMD Biosciences Inc., San Diego, CA). Reported values reflect wound fluid HNE levels, expressed as log-transformed concentrations (pg/mg) at Weeks 0, 4, 8 and 12.

Comparison of Intervention vs. Control Groups in the Percent Change in Wound Area Relative to Baseline

时间窗: 0, 4, 8 and 12 weeks

Percentage Area Reduction (PAR) is a valuable, widely used metric for evaluating and comparing the effectiveness of wound healing interventions in research. PAR was calculated at each follow-up time point (Weeks 4, 8, and 12) relative to the baseline. It represents the percentage change in wound size (area in cm2) from baseline, computed as: "PAR"=("Baseline Area" -"Follow-up Area" )/"Baseline Area" ×100 Positive PAR values indicate a reduction in wound area (i.e., healing), whereas negative values indicate an increase in wound size compared to baseline (i.e., the wound has enlarged).