"Unifuzol®" in Patients With Peripheral Arterial Disease

Inclusion criteria

• Signed Informed Consent
• Male and female patients 40-79 years old
• Patients with atherosclerosis of native arteries of the lower extremity vessels (ICD-10 code: I70.2)
• Clinical syndrome of chronic lower limb ischemia
• The symptom of intermittent claudication persisting for 6 months or more (before the start of screening), causing a stable restriction of physical activity to the maximum walking distance 100-299 m
• The ankle-brachial index (ABI) less than 0.9; in patients with diabetes mellitus ABI >1.2 is acceptable, provided the occlusion of the main arteries of the lower extremities is confirmed
• Patient consent to the use of adequate methods of contraception or full abstinence from sexual activity for the period of the study and within 30 days after its completion
• The difference between the maximum walking distance at the second and the first treadmill test at the screening (interval at least 3 days) does not exceed 25% from baseline, i.e. the first treadmill test
• Patients not receiving drugs for the treatment of atherosclerosis obliterans of the lower extremities or receiving them in constant doses for at least 6 weeks prior to screening.
• No contraindications for treadmill test

Exclusion criteria

• Intolerance or hypersensitivity to the components of the study drug.
• Intake of succinic acid, L-arginine, malic acid, fumaric acid, anticoagulants, or hormones (with the exception of insulin) within 6 weeks before the start of screening, or the use of these medications is scheduled within the patient's participation in the study
• Any severe disease or condition that may make it unsafe and/or impossible for the patient to participate in the study and/or lead to the inability of the patient to comply with the study procedures (including, but not limited to: renal failure, hepatic failure, blood diseases, psychiatric conditions, infections)
• History of malignancy (with the exception of basal cell skin cancer)
• Alcohol or drug abuse
• The presence of clinically significant decompensated cardiovascular diseases (unstable angina or stenocardia of functional class III and above, chronic heart failure III - IV class according to NYHA, uncontrolled arterial hypertension, acute cerebrovascular accident or acute myocardial infarction within 6 months prior to screening, unstable arrhythmias, deep venous thrombosis, stenosis of the internal carotid arteries >70%, aortic aneurysm)
• Decompensation of the peripheral circulation: rest pain, trophic ulcers, gangrene
• Any other diseases that affect the assessment of walking distance and limit patient's physical activity
• The level of glycated hemoglobin (HbA1c) >= 8%
• Planned reconstructive surgery on the limb vessels within 6 months from screening
• Amputation on one or both limbs or planned amputation within 6 months from screening
• Other circumstances impeding patient compliance with the schedule of procedures
• For patients applying or planning the use of NSAIDs: the inability to cancel the use of NSAIDs 12 hours before the treadmill test.
• The body mass index >35
• Contraindications for conducting the treadmill test
• Heart rate is more than 80% of the maximum frequency (the maximum frequency is defined as 220 - age) at the moment of pain in the legs.
• Depression of an ST segment or the occurrence of sustained (lasting more than 30 seconds) cardiac rhythm or conduction disturbances during a treadmill test.
• Drop of systolic blood pressure during the first 5 minutes after the completion of the treadmill test
• Participation in another clinical study
• Pregnancy or breastfeeding
• Any other diseases / conditions in the stage of decompensation
• Employees of the research center and their family members.