Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.

Last updated: June 27, 2023
Sponsor: Ryazan State Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peripheral Arterial Occlusive Disease

Treatment

Femoral-popliteal bypass grafting with a synthetic graft above the knee

Polypeptides

Routine conservative treatment

Clinical Study ID

NCT05933720
10
  • Ages 18-80
  • All Genders

Study Summary

The study is aimed at assessing the role of the activity of markers of endothelial dysfunction (cytotoxic malonic aldehyde (MDA), angiotensin II, endothelial nitric oxide synthase (NO), endothelin-1, prostacyclin) in the systemic circulation in patients with lower extremity atherosclerotic arterial occlusive disease undergoing open reconstructive interventions.

Eligibility Criteria

Inclusion

Inclusion Criteria: men or women over 18 years of age with lower extremity atherosclerotic arterial occlusivedisease, confirmed with instrumental work-up methods (ultrasonography or angiography).

Exclusion

Exclusion Criteria: men or women under 18 years of age; history of anaphylaxis; hypersensitivity to any of thecomponents that make up the drug Slavinorm®, and proteins of animal origin; absolute andrelative contraindications to the treadmill test; failure to walk at a minimum speed of 3.2km/h (2 mph) at a minimum treadmill angle for at least 2 minutes during the stress testduring the screening phase; depression of the ST segment more than 1 mm in one or morestandard leads on the electrocardiogram; peripheral artery disease not associated withatherosclerosis; patients who underwent reconstructive surgery or invasive interventions onthe arteries of the lower extremities in history without a clinic of intermittentclaudication; angina pectoris III-IV functional class (FC) according to the CCSclassification; body mass index >35 kg/m2; acute or chronic renal (creatinine clearanceless than 30 ml / min) and / or liver failure [aspartate aminotransferase (AST), alanineaminotransferase (ALT) > 3 times the upper limit of normal]; chronic heart failure III-IVFC according to NYHA; acute coronary syndrome within 6 months. before the start of thescreening period; any clinically significant condition or comorbidity that, in the opinionof the Investigator, would preclude the patient from participating in the study.

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Femoral-popliteal bypass grafting with a synthetic graft above the knee
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
September 01, 2026

Study Description

The study will include 120 patients of similar age, gender, and ethnicity, they will be divided into four groups: Group I: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy; Group II: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®; Group III: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stageIII-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee); Group IV: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage III-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®, in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee).

Connect with a study center

  • RyazanSMU

    Ryazan,
    Russian Federation

    Active - Recruiting

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