Lipid Peroxidation and Options Antioxidant Therapy for Secondary Lymphedema of the Lower Extremities
Status:
Recruiting
Trial end date:
2022-08-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Ryazan State Medical University
Treatments:
alpha-Tocopherol Tocopherols Tocotrienols Vitamin E