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

Ulcers Related to Diabetic Foot Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538705
• Other study ID #: NeoFoot Pilot Study
• Status: Completed
• Phase: N/A
• First received: August 30, 2015
• Last updated: April 4, 2017
• Start date: August 2015
• Est. completion date: January 1, 2016

Study information

• Verified date: August 2015
• Source: Human Stem Cell Institute, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 1, 2016
• Est. primary completion date: January 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Foot
• Syndrome
• Ulcers Related to Diabetic Foot Syndrome

Intervention

Drug:
• Neovasculgen

Locations

Country	Name	City	State
Russian Federation	Human Stem Cell Institute	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
Human Stem Cell Institute, Russia	Ryazan State Medical University named after academician I.P. Pavlov, Vidnoe District Hospital

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area of diabetic foot ulcers	To determine the ability of pl-vegf165 to facilitate and accelerate diabetic foot ulcers healing	180 days
Secondary	Transcutaneous oxygen pressure	To determine the ability of pl-vegf165 to improve blood circulation in affected extremity by angiogenesis inducing	180 days