NCT07391319

The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial

"Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Study of the Efficacy and Safety of the Drug Neovasculgen® Lyophilisate for the Preparation of a Solution for Intramuscular Administration 1.2 mg", Manufacturer Federal State Budgetary Institution "NMITs of Hematology" of the Ministry of Health of the Russian Federation, Russia in Patients With Diabetic Foot Syndrome"

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: JSC NextGen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to evaluate the efficacy and safety of Neovasculgen® in a course dose of 2.4 mg in combination with standard drug therapy in patients with unilateral neuroischemic form of diabetic foot syndrome.

Conditions

• Ulcer Foot
• Mellitus Diabetes

Interventions

Type	Name	Description
DRUG	Neovasculgen®	The diluted drug will be administered by 5-10 injections intramuscularly twice with an interval of 14 days, in the course dosage mode - 2.4 mg
DRUG	Placebo	Placebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days

Timeline

• Start date: 2025-02-11
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: Russia