Lower Limb Ischemia
Conditions
Keywords
Ischemia
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
Interventions
DRUGNeovasculgen®
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).
Sponsors
Artgen Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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® |
Countries
Russia
Outcome results
None listed