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

Phase

N/A

Condition

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT02538705

NeoFoot Pilot Study

Ages > 18
All Genders

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Any disease that can, in the opinion of the treating physician, affect the outcome ofthe 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

August 01, 2015

January 01, 2016

Study 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.

Connect with a study center

Human Stem Cell Institute
Moscow,
Russian Federation
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.