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NCT Number: NCT04360889

Lipid Peroxidation and Options Antioxidant Therapy for Secondary Lymphedema of the Lower Extremities

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.

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Key information

Conditions

Lower Extremity Lymphedema

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ryazan State Medical University

Ryazan, 390026, Russia

About this study

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"

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Secondary lymphedema of the lower extremities
  • Signed Informed Consent Form

Exclusion criteria

  • varicose veins of the lower extremities,
  • deep vein thrombosis,
  • post-thrombotic disease,
  • obliterating
  • atherosclerosis of the lower limb arteries,
  • pregnancy,
  • lactation,
  • cancer,
  • 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.

Treatment and study plan

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

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

Primary outcomes

  1. The malleolar volume of the limb

    Time frame: 90 days

    The circumference at the level of the narrowest part of the lower leg, measured in centimeters

  2. The Level Of Catalase

    Time frame: 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

  3. The Level Of Superoxide Dismutase

    Time frame: 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

  4. The Level Of Glutathione Peroxidase

    Time frame: 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

  5. The level of Malondialdehyde

    Time frame: 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

  6. Quality of life indicators: questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ryazan State Medical University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2020
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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