Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia

Study Overview
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Brief Summary
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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
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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

Official Title
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International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease

Conditions
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Lower Limb Ischemia

Intervention / Treatment
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* Drug: Neovasculgen®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neovasculgen®<br>Single group prospective treatment | Drug: Neovasculgen®<br>* Treatment according to routine clinical practice at the discretion of the treating physician. Patients receive two local intramuscular injections of Neovasculgen® at a course dose of 2.4 mg according to the summary of product characteristics (SmPC).<br>* Other names: Neovasculgen;|
| Active Comparator: standard care<br> | Drug: Neovasculgen®<br>* Treatment according to routine clinical practice at the discretion of the treating physician. Patients receive two local intramuscular injections of Neovasculgen® at a course dose of 2.4 mg according to the summary of product characteristics (SmPC).<br>* Other names: Neovasculgen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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® | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemia