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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Stem Cell Institute, Russia
• Collaborators: Ryazan State Medical University; Ryazan State Medical University named after academician I.P. Pavlov; Saint-Petersburg state hospital №14; Vidnoe District Hospital

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)