Study of the Safety and Effectiveness of Vascular Polypeptide Drug and Surgical Bypass for Lower Leg Artery Disease

What this Trial Is About

Researchers are evaluating the role of markers of endothelial dysfunction in the blood of patients with lower extremity atherosclerotic arterial occlusive disease who are undergoing open reconstructive interventions. The study aims to assess these markers in different stages of the disease and compare various treatment approaches, including conservative therapy and surgical methods. The research will involve 120 patients divided into four groups based on disease severity and treatment type, focusing on understanding how these markers relate to disease progression and treatment outcomes. Participants will be assigned to one of four groups those receiving routine conservative treatment those receiving conservative treatment plus a drug based on vascular polypeptides called Slavinorm4 those undergoing femoral-popliteal bypass grafting surgery combined with conservative treatment and those receiving both surgery and the polypeptide drug treatment. The polypeptide treatment involves intramuscular injections of 5 mg, given twice weekly for a total of 10 injections. Surgical treatment consists of bypass grafting with a synthetic graft above the knee. Throughout the study, participants will be monitored for outcomes such as thrombosis of lower arteries or bypass grafts, disease progression, and restenosis over one year. Secondary measures include limb loss, changes in pain-free walking distance, and ankle-brachial index improvements. Researchers will use instrumental methods like ultrasonography or angiography for diagnosis and follow-up. The study lasts up to one year with assessments of clinical status, walking ability, and vascular function to evaluate the safety and efficacy of the treatments.

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