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The present study is a multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of the drug Unifuzol® (L-arginine) in patients with obliterating atherosclerosis of the lower extremities. The study recruits patients 40-79 years old with a confirmed diagnosis of chronic ischemia of the lower limb and a stable symptom of intermittent claudication that occurs when walking a distance of 100-299 meters. L-arginine improves microcirculation due to activation of nitrogen monoxide production and stimulates capillary blood flow, thus can probably improve the quality of life of patients with intermittent claudication. The criterion for treatment efficacy will be an increase in the maximum walking distance measures before and on the next day after the end of treatment course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unifuzol® 1.4% 500 ml | Experimental | Patients receive the infusion of investigational drug L-arginine 1.4% 500 ml IV daily for 10 days |
|
| Unifuzol® 1.4% 250 ml | Experimental | Patients receive the infusion of L-arginine 1.4% 250 ml + placebo 250 ml IV daily for 10 days |
|
| Placebo 500 ml | Placebo Comparator | Patients receive the infusion of placebo solution for intravenous infusions 500 ml IV daily for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-arginine 1.4% 500 ml | Drug | Infusion of L-arginine 1.4% solution by 500 ml (2 vials 250 ml each) IV daily for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum walking distance | The change in the maximum walking distance on the next day (day 11) after the completion of treatment course and on day 30 in comparison with the initial value. The change will be expressed as the ratio of the natural logarithms of the maximum walking distance on day 11 and to the baseline value (day 1). | day 11, day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail S Bogomolov, MD, PhD | St. Petersburg State Medical University n.a. I.P.Pavlov | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Clinical Hospital | Barnaul | Russia | ||||
| Kursk City Clinical Emergency Hospital |
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| L-arginine 1.4% 250 ml + placebo 250 ml | Drug | Infusion of L-arginine 1.4% solution 250 ml IV daily for 10 days and placebo infusion by 250 ml IV daily for 10 days. |
|
|
| Placebo solution | Drug | Infusion of Ringer's solution by 500 ml (2 vials 250 ml each) IV daily for 10 days |
|
|
| Kursk |
| Russia |
| City Clinical Hospital № 15 named O.M. Filatov | Moscow | Russia |
| Medical and sanitary Department of the Ministry of Internal Affairs of the Russian Federation in Moscow | Moscow | Russia |
| City Clinical Hospital №2 of the Novosibirsk Region | Novosibirsk | Russia |
| National Medical Research Center named after Academician E.N. Meshalkin | Novosibirsk | Russia |
| State Novosibirsk Regional Clinical Hospital | Novosibirsk | Russia |
| Multidisciplinary center of modern medicine "Euromed" | Omsk | Russia |
| Orenburg Regional Clinical Hospital | Orenburg | Russia |
| Rostov State Medical University | Rostov-on-Don | Russia |
| Ryazan Regional Clinical Cardiological dispensary | Ryazan | Russia |
| City General Hospital №2 | Saint Petersburg | Russia |
| City Hospital №38 named after N.A. Semashko | Saint Petersburg | Russia |
| Consultative and diagnostic center No. 85 | Saint Petersburg | Russia |
| Road Clinical Hospital of the Russian Railways Open Joint-Stock Company | Saint Petersburg | Russia |
| St. Petersburg State Medical University n.a. I.P.Pavlov | Saint Petersburg | Russia |
| Regional Clinical Cardiology Dispensary | Saratov | Russia |
| Clinical hospital №10 of the Yaroslavl region | Yaroslavl | Russia |
| Regional Clinical Hospital of the Yaroslavl region | Yaroslavl | Russia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D001157 | Arterial Occlusive Diseases |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001120 | Arginine |
| D000077331 | Ringer's Solution |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D000601 | Amino Acids, Essential |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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