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Completed

NCT Number: NCT02369809

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

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®.

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Key information

Conditions

Lower Limb Ischemia Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

"Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution, Barnaul, Altayskiy Kray, Russia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neovasculgen®

Drug

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).

Other names: Neovasculgen

Primary outcomes

  1. 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

  1. 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®

  2. Change in the ankle-brachial index (ABI) after injection of Neovasculgen®

    Time frame: 3 months and 6 months after the first injection of Neovasculgen®

  3. Change in blood flow linear velocity (BFLV) after injection of Neovasculgen®

    Time frame: 3 months and 6 months after the first injection of Neovasculgen®

  4. Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen®

    Time frame: 3 months and 6 months after the first injection of Neovasculgen®

Sponsors and collaborators

Lead sponsor

Artgen Biotech

Other

Registry information

Official study title

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

Acronym: NVG-LIGHT

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2015
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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