Overview

This trial has been completed.

Condition lower limb ischemia
Treatment neovasculgen®
Phase phase 4
Sponsor Human Stem Cell Institute, Russia
Start date September 2012
End date January 2017
Trial size 210 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

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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).
(Active Comparator)
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 International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease
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
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Human Stem Cell Institute, Russia.