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

NCT04360889 | Completed Phase 4

• 1 other identifier: MDA-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Lymphedema

Keywords

endothelial dysfunction; secondary lymphedema of the lower extremities; antioxidants; micronized purified flavonoid fraction

Outcome Measures

Primary Outcomes (6)

• 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

  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

Study Arms (4)

Tocopherol

EXPERIMENTAL

patients with lower limb lymphedema who will receive conservative therapy with elastic compression and an antioxidant (Tocopherol-400 IU/day) - 90 days

Drug: Tocopherol

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

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

Elastic compression

OTHER

patients with lower limb lymphedema who will be treated with elastic compression - 90 days

Other: Elastic compression

Healthy volunteers

NO INTERVENTION

healthy volunteers with no history or clinical signs of venous or lymphatic disease - 90 days

Interventions

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

Micronised purified flavonoid fraction

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)

Tocopherol

Elastic compression OTHER

patients with lower limb lymphedema receiving conservative therapy that includes only the use of elastic compression

Elastic compression

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• heart failure,
• kidney failure,
• pulmonary insufficiency.

Sponsors & Collaborators

• Ryazan State Medical University: lead

Study Sites (1)

Ryazan State Medical University

Ryazan, 390026, Russia

Location

MeSH Terms

Interventions

Hesperidin; Tocopherols

Intervention Hierarchy (Ancestors)

Flavanones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates; Vitamin E

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 24, 2020
• Study Start: September 1, 2019
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)