NCT05933720 Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.
| NCT ID | NCT05933720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ryazan State Medical University |
| Condition | Peripheral Arterial Occlusive Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-04-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Igor Suchkov
STUDY CHAIR
Ryazan State Medical University
Frequently Asked Questions
Who can join the NCT05933720 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Peripheral Arterial Occlusive Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05933720 currently recruiting?
Yes, NCT05933720 is actively recruiting participants. Contact the research team at suchkov_med@mail.ru for enrollment information.
Where is the NCT05933720 trial being conducted?
This trial is being conducted at Ryazan, Russia.
Who is sponsoring the NCT05933720 clinical trial?
NCT05933720 is sponsored by Ryazan State Medical University. The principal investigator is Igor Suchkov at Ryazan State Medical University. The trial plans to enroll 120 participants.