Lipid Peroxidation and Options Antioxidant Therapy for Secondary Lymphedema of the Lower Extremities
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The level of Malondialdehyde
研究概览
简要总结
A single-center, open, prospective, randomized, controlled clinical trial will include 120 patients with lower limb lymphedema who undergo treatment in an office-based vascular lab at the Ryazan regional clinical cardiology dispensary, Ryazan, Russia. The patients will be recruited by the staff of the Department of cardiovascular, endovascular, operative surgery, and topographic anatomy, Ryazan state I.P. Pavlov medical university, Russia. The study will include patients who meet the inclusion criteria and do not meet the exclusion criteria. Patients will be divided into 4 groups, 30 subjects each. Group 1-patients with lower limb lymphedema who will receive conservative therapy with elastic compression and an antioxidant (Tocopherol-400 IU/day); Group 2-patients with lower limb lymphedema who will receive conservative therapy with Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)-1000mg/day) in addition to elastic compression; Group 3-patients with lower limb lymphedema who will be treated with elastic compression; Group 4- healthy volunteers with no history or clinical signs of venous or lymphatic disease; The duration of this study for each subject will be a maximum of 90 days. Pre-screening and screening will involve 200 subjects with a total of 120 subjects who will be randomized into the study. Peripheral blood samples will be collected to evaluate the activity of biochemical markers of endothelial function; the quality of life will also be assessed.
详细描述
Research methods:
- Physical examination;
- peripheral blood sampling (assessment of the concentration of the markers of endothelial dysfunction, including malondialdehyde (MDA), superoxide dismutase (SD), catalase( CAT), glutathione peroxidase (GP). MDA concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a General MDA assessment kit (manufacturer: USCN Life Science Inc. US-CEA597GE). CAT concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed with a kit for quantitative in vitro assessment of catalase (manufacturer: USCN Life Science Inc. US-SEC418Hu). GP concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a glutathione peroxidase quantification set (abfrontier supplier, Republic of Korea - LF- EK0110). SOD concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed using a total superoxide dismutase detection kit (supplier Cayman Chemical Company, US - 706002).
- Lower limb venous sonography with a linear 5-13 MHz probe;
- Patient questionnaire using a Russian-language version of the Quality of life questionnaire "SF-36 Health Status Survey"
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Secondary lymphedema of the lower extremities
- •Signed Informed Consent Form
排除标准
- •varicose veins of the lower extremities,
- •deep vein thrombosis,
- •post-thrombotic disease,
- •obliterating
- •atherosclerosis of the lower limb arteries,
- •pregnancy,
- •lactation,
- •acute violation of cerebral circulation in the anamnesis,
- •trophic lesions of the skin of the lower extremities,
- •diabetes mellitus
- •an infectious disease with a history of three months prior to inclusion in the study,
- •heart failure,
- •kidney failure,
- •pulmonary insufficiency.
研究组 & 干预措施
Tocopherol
patients with lower limb lymphedema who will receive conservative therapy with elastic compression and an antioxidant (Tocopherol-400 IU/day) - 90 days
干预措施: Tocopherol (Drug)
Micronised purified flavonoid fraction
patients with lower limb lymphedema who will receive conservative therapy with Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)-1000mg/day) in addition to elastic compression - 90 days
干预措施: Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) (Drug)
Elastic compression
patients with lower limb lymphedema who will be treated with elastic compression - 90 days
干预措施: Elastic compression (Other)
结局指标
主要结局
The level of Malondialdehyde
时间窗: 90 days
Biochemical indicator of the functional state of the endothelium. Malondialdehyde concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a General MDA assessment kit (manufacturer: USCN Life Science Inc. US-CEA597GE). Unit of measurement ng / ml
The malleolar volume of the limb
时间窗: 90 days
The circumference at the level of the narrowest part of the lower leg, measured in centimeters
The Level Of Catalase
时间窗: 90 days
Biochemical indicator of the functional state of the endothelium. Catalase concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed with a kit for quantitative in vitro assessment of catalase (manufacturer: USCN Life Science Inc. US-SEC418Hu). Unit of measurement ng / ml
The Level Of Superoxide Dismutase
时间窗: 90 days
Biochemical indicator of the functional state of the endothelium. Superoxide Dismutase concentration will be determined using a competitive enzyme immunoassay (ELISA), which will be performed using a total superoxide dismutase detection kit (supplier Cayman Chemical Company, US - 706002). Unit of measurement UI / ml
The Level Of Glutathione Peroxidase
时间窗: 90 days
Biochemical indicator of the functional state of the endothelium. Glutathione Peroxidase concentration will be determined with a competitive enzyme immunoassay (ELISA), which will be performed using a glutathione peroxidase quantification set (abfrontier supplier, Republic of Korea - LF- EK0110). Unit of measurement ng / ml
Quality of life indicators: questionnaire
时间窗: 90 days
Patient questionnaire using a Russian-language version of the Quality of life questionnaire "Short Form-36 Health Status Survey". 8 indicators. Indicator from 0 to 100. Higher scores mean a better outcome.
次要结局
未报告次要终点