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Completed

NCT Number: NCT02538705

Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Diabetic Foot

The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of ulcers related to diabetic foot syndrome

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Key information

Conditions

Ulcers Related to Diabetic Foot Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Stem Cell Institute

Moscow, Russia

About this study

This is a open clinical trial assessing the therapeutic efficacy of pl-vegf165 (Neovasculgen) in treating ulcers related to diabetic foot syndrome. Each patient will undergo several intramuscular injections with a treatment dose of pl-vegf165 (Neovasculgen) in calf of affected extrimity.

Study participants at the first study visit will complete study questionnaires, their foots will be assessed clinically for ulceration. After this initial assessment, the patients will undergo intramuscular injections of pl-vegf165 (Neovasculgen) in a calf altered with ulcers due to diabetic foot syndrome.

At three month post-injection, the patient will complete study questionnaires, their foots will be assessed clinically for ulceration, and their foots will undergo non-invasive transcutaneous oximetry measurement. At six months post-injection, the patient will again complete study questionnaires, their foots will be assessed clinically for ulceration and will undergo non-invasive transcutaneous oximetry measurement.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • obtained voluntary informed consent for participation in the clinical study
  • presence of diabetic foot syndrome
  • presence at least one active ulcer at baseline

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

Other names: pl-vegf165

Primary outcomes

  1. Area of diabetic foot ulcers

    Time frame: 180 days

    To determine the ability of pl-vegf165 to facilitate and accelerate diabetic foot ulcers healing

Secondary outcomes

  1. Transcutaneous oxygen pressure

    Time frame: 180 days

    To determine the ability of pl-vegf165 to improve blood circulation in affected extremity by angiogenesis inducing

Sponsors and collaborators

Lead sponsor

Artgen Biotech

Other

Collaborators

  • Ryazan State Medical University
  • Vidnoe District Hospital

Registry information

Official study title

Safety and Efficacy Study of Pl-vegf165 to Treat Diabetic Foot Syndrome

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 2, 2015
Registry last updated
Apr 5, 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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