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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02538705

Enrollment

Registered

2015-09-02

Start date

2015-08-31

Completion date

2016-01-01

Last updated

2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcers Related to Diabetic Foot Syndrome

Keywords

Diabetic foot syndrome, Ulcers

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.

Interventions

DRUGNeovasculgen

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026