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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02538705
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : April 5, 2017
Sponsor:
Collaborators:
Ryazan State Medical University
Vidnoe District Hospital
Information provided by (Responsible Party):
Human Stem Cell Institute, Russia

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

Condition or disease Intervention/treatment Phase
Ulcers Related to Diabetic Foot Syndrome Drug: Neovasculgen Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Pl-vegf165 to Treat Diabetic Foot Syndrome
Actual Study Start Date : August 2015
Actual Primary Completion Date : January 1, 2016
Actual Study Completion Date : January 1, 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Neovasculgen Drug: Neovasculgen
Other Name: pl-vegf165


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538705


Locations
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Russian Federation
Human Stem Cell Institute
Moscow, Russian Federation
Sponsors and Collaborators
Human Stem Cell Institute, Russia
Ryazan State Medical University
Vidnoe District Hospital
More Information
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Responsible Party: Human Stem Cell Institute, Russia
ClinicalTrials.gov Identifier: NCT02538705    
Other Study ID Numbers: NeoFoot Pilot Study
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: August 2015
Keywords provided by Human Stem Cell Institute, Russia:
Diabetic foot syndrome
Ulcers
Additional relevant MeSH terms:
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Diabetic Foot
Syndrome
Disease
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
 Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies