Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Levels of eicosapentaenoic (EPA)+ docosahexaenoic (DHA)-derived lipid mediators and proinflammatory cytokines in blood and CVLU wound fluid
时间窗: 0, 28, 56 days
次要结局
- PMN counts and levels of PMN-derived proteases in CVLU wound fluid(0, 28, 56 days)
研究者
Jodi McDaniel
Associate Professor
Ohio State University