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

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ClinicalTrials.gov Identifier: NCT04360889
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Ryazan State Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lower Extremity Lymphedema Drug: Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) Drug: Tocopherol Other: Elastic compression Phase 4

Detailed Description:

Research methods:

  1. Physical examination;
  2. 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).
  3. Lower limb venous sonography with a linear 5-13 MHz probe;
  4. Patient questionnaire using a Russian-language version of the Quality of life questionnaire "SF-36 Health Status Survey"

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lipid Peroxidation and Options Antioxidant Therapy for Secondary Lymphedema of the Lower Extremities
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Tocopherol

Arm Intervention/treatment
Experimental: Tocopherol
patients with lower limb lymphedema who will receive conservative therapy with elastic compression and an antioxidant (Tocopherol-400 IU/day) - 90 days
Drug: Tocopherol
patients with lower limb lymphedema receiving conservative therapy (elastic compression, to which are added preparations with antioxidant endotheliotropic activity (Tocopherol-400 IU/day)

Experimental: 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
Drug: Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)
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

Elastic compression
patients with lower limb lymphedema who will be treated with elastic compression - 90 days
Other: Elastic compression
patients with lower limb lymphedema receiving conservative therapy that includes only the use of elastic compression

No Intervention: Healthy volunteers
healthy volunteers with no history or clinical signs of venous or lymphatic disease - 90 days



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360889


Contacts
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Contact: Denis A. Maksaev +79156005484 denma1804@yandex.ru

Locations
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Russian Federation
Ryazan State Medical University Recruiting
Ryazan', Russian Federation, 390026
Contact: Denis A. Maksaev    +79156005484    denma1804@yandex.ru   
Sponsors and Collaborators
Ryazan State Medical University
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Responsible Party: Ryazan State Medical University
ClinicalTrials.gov Identifier: NCT04360889    
Other Study ID Numbers: MDA-1
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryazan State Medical University:
endothelial dysfunction
secondary lymphedema of the lower extremities
antioxidants
micronized purified flavonoid fraction
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances