Overview

This trial is active, not recruiting.

Condition lower limb ischemia
Treatment neovasculgen®
Sponsor Human Stem Cell Institute, Russia
Start date September 2012
End date May 2015
Trial size 200 participants
Trial identifier NCT02369809, NVG-03

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®.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Single group prospective treatment
neovasculgen® Neovasculgen
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).

Primary Outcomes

Measure
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®.

Secondary Outcomes

Measure
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®

Eligibility Criteria

Male or female participants at least 40 years old.

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)

Additional Information

Official title Non-Interventional Post Marketing Surveillance Study to Evaluate Safety and Efficacy of Neovasculgen® in Patients With Stage IIA-III Chronic Lower Limb Ischemia (According to Pokrovsky-Fontaine Classification)
Description This is a prospective, observational, non-interventional, multicenter, post-marketing surveillance study to collect safety and efficacy information of Neovasculgen® in the real world patient population diagnosed with lower limb ischemia (Fontaine-Pokrovsky Stages IIa-III of Chronic Limb Ischemia). In addition to the conventional vascular therapy patients receive two local intramuscular injections of Neovasculgen® at a course dose of 2.4 mg according to the summary of product characteristics (SmPC).
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Human Stem Cell Institute, Russia.