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

Not Applicable

Completed

• Conditions: Ulcers Related to Diabetic Foot Syndrome
• Interventions: Drug: Neovasculgen

• Registration Number: NCT02538705
• Lead Sponsor: Human Stem Cell Institute, Russia

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

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 Timeline

• Status Verified: 2015-08
• Study Start: 2015-08
• Study First Submitted: 2015-08-30
• Study First Submitted QC: 2015-08-30
• Study First Posted: 2015-09-02
• Primary Completion: 2016-01-01
• Study Completion: 2016-01-01
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neovasculgen	Neovasculgen	-

Primary Outcome Measures

Name	Time	Method
Area of diabetic foot ulcers	180 days	To determine the ability of pl-vegf165 to facilitate and accelerate diabetic foot ulcers healing

Secondary Outcome Measures

Name	Time	Method
Transcutaneous oxygen pressure	180 days	To determine the ability of pl-vegf165 to improve blood circulation in affected extremity by angiogenesis inducing

Trial Locations

Locations (1)

Human Stem Cell Institute; 🇷🇺 Moscow, Russian Federation