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

April 4, 2017 updated by: Human Stem Cell Institute, Russia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neovasculgen
Drug: Neovasculgen
Other Names:
  • pl-vegf165

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area of diabetic foot ulcers
Time Frame: 180 days
To determine the ability of pl-vegf165 to facilitate and accelerate diabetic foot ulcers healing
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcutaneous oxygen pressure
Time Frame: 180 days
To determine the ability of pl-vegf165 to improve blood circulation in affected extremity by angiogenesis inducing
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Human Stem Cell Institute, Russia

Collaborators

Ryazan State Medical University
Vidnoe District Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 30, 2015

First Submitted That Met QC Criteria

August 30, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeoFoot Pilot Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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