Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Research methods:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocopherol | Experimental | patients with lower limb lymphedema who will receive conservative therapy with elastic compression and an antioxidant (Tocopherol-400 IU/day) - 90 days |
|
| Micronised purified flavonoid fraction | Experimental | 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 |
|
| Elastic compression | Other | patients with lower limb lymphedema who will be treated with elastic compression - 90 days |
|
| Healthy volunteers | No Intervention | healthy volunteers with no history or clinical signs of venous or lymphatic disease - 90 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) | Drug | Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) is prescribed at a dose of 1000 mg / day Tocopherol is prescribed at a dose of 400 ME/ day |
| Measure | Description | Time Frame |
|---|---|---|
| The malleolar volume of the limb | The circumference at the level of the narrowest part of the lower leg, measured in centimeters | 90 days |
| The Level Of Catalase | 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 | 90 days |
| The Level Of Superoxide Dismutase | 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 | 90 days |
| The Level Of Glutathione Peroxidase | 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 | 90 days |
| The level of Malondialdehyde | 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 | 90 days |
| Quality of life indicators: questionnaire |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryazan State Medical University | Ryazan | 390026 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tocopherol | Drug | patients with lower limb lymphedema receiving conservative therapy (elastic compression, to which are added preparations with antioxidant endotheliotropic activity (Tocopherol-400 IU/day) |
|
| Elastic compression | Other | patients with lower limb lymphedema receiving conservative therapy that includes only the use of elastic compression |
|
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. |
| 90 days |
| ID | Term |
|---|---|
| D006569 | Hesperidin |
| D024505 | Tocopherols |
| ID | Term |
|---|---|
| D044950 | Flavanones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014810 | Vitamin E |
Not provided
Not provided