Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia
- Conditions
- Lower Limb Ischemia
- Interventions
- Drug: Neovasculgen®
- Registration Number
- NCT02369809
- Lead Sponsor
- Human Stem Cell Institute, Russia
- Brief Summary
Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in daily clinical practice and obtain information about the quality of life in patients treated with Neovasculgen®.
- Detailed Description
This is an open, controlled, prospective, comparative, multicentre study design. All patients received standard conservative therapy for chronic limb ischemia without cilostazol and prostaglandins and without surgical or endovascular vessel reconstruction. Surgical and endovascular vessel reconstruction was unsuitable for all of the patients
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- Male or female person aged 40 or older
- Subject with diagnosed lower limb ischemia (Fontaine-Pokrovsky Stages IIa-III of chronic limb ischemia)
- Signed informed consent
- Any disease that can, in the opinion of the treating physician, affect the outcome of the study
- Patients with addictive disorders or substance abuse
- Pregnancy or nursing
- All other exclusion criteria listed in the summary of product characteristics (SmPC)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard care Neovasculgen® - Neovasculgen® Neovasculgen® Single group prospective treatment
- Primary Outcome Measures
Name Time Method Change in the measurement of pain-free walking distance (PWD) on treadmill 3 months and 6 months after the first injection of Neovasculgen®.
- Secondary Outcome Measures
Name Time Method Number of adverse drug reactions (ADRs) and unexpected adverse drug reactions (UADRs) From the first injection of Neovasculgen® until six months after the secondary injection of Neovasculgen® Change in the ankle-brachial index (ABI) after injection of Neovasculgen® 3 months and 6 months after the first injection of Neovasculgen® Change in blood flow linear velocity (BFLV) after injection of Neovasculgen® 3 months and 6 months after the first injection of Neovasculgen® Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen® 3 months and 6 months after the first injection of Neovasculgen®
Trial Locations
- Locations (30)
State Institution of Health of the Tyumen region "Regional Clinical Hospital #1"
🇷🇺Tyumen, Khanty-Mansiysk District, Russian Federation
Voronezh State Medical Academy Named After N.N Burdenko
🇷🇺Voronezh, Voronezh Region, Russian Federation
"Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution
🇷🇺Barnaul, Altai Region, Russian Federation
State Institution of Health Amur Region "Amur Regional Clinical Hospital"
🇷🇺Blagoveshchensk, Amur Region, Russian Federation
State Institution of Health Irkutsk "Badge of Honor" Regional Hospital
🇷🇺Irkutsk, Irkutsk Region, Russian Federation
Regional State Budget Institution of Additional Professional Education "Institute of Institute for Advanced Studies of Health Professionals" of the Ministry of Health of the Khabarovsk Region
🇷🇺Khabarovsk, Khabarovsk Region, Russian Federation
Regional Clinical Hospital #1 Named after Prof. S.V.Ochapovskogo of the Ministry of Health of Krasnodar Region
🇷🇺Krasnodar, Krasnodar Region, Russian Federation
State Institution of Health of Novosibirsk Region "City Clinical Hospital #1"
🇷🇺Novosibirsk, Novosibirsk Region, Russian Federation
Federal State Institution "Research Institute of Clinical and Experimental Lymphology"
🇷🇺Novosibirsk, Novosibirsk Region, Russian Federation
Budget Health Care Institution of Omsk Region "Regional Hospital"
🇷🇺Omsk, Omsk Region, Russian Federation
Public Health Institution "Primorsky Regional Clinical Hospital #1",
🇷🇺Vladivostok, Primorsky Region, Russian Federation
State Educational Institution of Higher Professional Education "Rostov State Medical University"
🇷🇺Rostov-na-Donu, Rostovskaya, Russian Federation
St. Petersburg Research Institute of Emergency Care named after I.I. Dzhanelidze
🇷🇺Saint Petersburg, Saint Petersburg Region, Russian Federation
State Budgetary Healthcare Institution "Samara Regional Clinical Hospital Named after M.I. Kalinin "
🇷🇺Samara, Samara Region, Russian Federation
Budgetary State Institution Samara Region Hospital # 2 Named after V.V. Banykin
🇷🇺Togliatti, Samara Rigion, Russian Federation
Public Health Autonomous Institution "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
🇷🇺Kazan, Tatarstan, Russian Federation
Budgetary State Institution "Regional Hospital"
🇷🇺Tver, Tver Region, Russian Federation
Sverdlovsk Regional Clinical Hospital #1
🇷🇺Ekaterinburg, Sverdlovsk Region, Russian Federation
State Institution of Health "Salekhard District Hospital"
🇷🇺Salekhard, Yamal-Nenets, Russian Federation
State Health Care Institution "Regional Clinical Hospital"
🇷🇺Chita, Zabaikalskii Region, Russian Federation
State Institution of Health Yaroslavl Region "Clinical Hospital # 10"
🇷🇺Yaroslavl, Yaroslavl Region, Russian Federation
Municipal Budget Health Institution "City Clinical Hospital of Emergency Medical Care Named after N.C Karpovich "
🇷🇺Krasnoyarsk, Krasnoyarsk Region, Russian Federation
Federal State Institution "GBUZ MO MONIKI Named after M.F. Vladimirskogo "
🇷🇺Moscow, Moscow Region, Russian Federation
Republican Clinical Hospital
🇷🇺Yoshkar-Ola, Mari El Republic, Russian Federation
State Budgetary Healthcare Institution "Republican Clinical Hospital Named after N.A Semashko "
🇷🇺Ulan-Ude, Buryatiya, Russian Federation
Autonomous Healthcare Institution "Irkutsk Clinical Hospital #1 "
🇷🇺Irkutsk, Irkutsk Region, Russian Federation
Russian Academy Of Medical Sciences. Reserch Institute For Complex Problems Of Cardiovascular Diseases
🇷🇺Kemerovo, Kemerovskaya, Russian Federation
City Clinical Hospital # 21 Ufa
🇷🇺Ufa, Bashkortastan, Russian Federation
Municipal Budget Health Care Institution "City Clinical Hospital № 8". Chelyabinsk
🇷🇺Chelyabinsk, Chelyabinsk Region, Russian Federation
State Institution of Health of Kemerovo Region "Kemerovo Regional Hospital"
🇷🇺Kemerovo, Kemerovo Region, Russian Federation