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®.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
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).
Change in the measurement of pain-free walking distance (PWD) on treadmill
Time frame: 3 months and 6 months after the first injection of Neovasculgen®.
Number of adverse drug reactions (ADRs) and unexpected adverse drug reactions (UADRs)
Time frame: 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®
Time frame: 3 months and 6 months after the first injection of Neovasculgen®
Change in blood flow linear velocity (BFLV) after injection of Neovasculgen®
Time frame: 3 months and 6 months after the first injection of Neovasculgen®
Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen®
Time frame: 3 months and 6 months after the first injection of Neovasculgen®
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...and 20 more locations