Evaluating the effects of polypeptides in patients with peripheral atherosclerosis

Evaluation of the Efficacy and Safety of the Drug Based on Vascular Regulatory Polypeptides for the Treatment of Patients With Lower Extremity Atherosclerotic Arterial Occlusive Disease.

This study is testing if a new polypeptide drug called Slavinorm® can help improve blood flow and overall health in people with blocked arteries in their legs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Ryazan State Medical University (Academic / other)
• Locations: 1 site (Ryazan)
• Trial ID: NCT05933720 on ClinicalTrials.gov

What this trial studies

This study assesses the efficacy and safety of vascular polypeptides in patients with lower extremity atherosclerotic arterial occlusive disease. It involves 120 participants divided into four groups based on disease stage and treatment approach, including conservative therapy and surgical interventions. The study aims to measure the activity of various markers of endothelial dysfunction in the systemic circulation. Participants will be monitored for their response to treatment with and without the polypeptide drug Slavinorm®.

Who should consider this trial

Good fit: Ideal candidates are men and women over 18 years old diagnosed with lower extremity atherosclerotic arterial occlusive disease.

Not a fit: Patients under 18 years old or those with contraindications to the study treatments will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with peripheral arterial disease by enhancing the effectiveness of existing therapies.

How similar studies have performed: While the use of polypeptides in this context is relatively novel, similar studies have shown promise in improving vascular health.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Ryazan

• RyazanSMU — Ryazan, Russia (Recruiting)

Study contacts

• Study coordinator: Igor Aleksadrovich Suchkov

Conditions Peripheral Arterial Occlusive Disease; Peripheral Arterial Disease; bypass grafting; polypeptides