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RECRUITING
NCT07391319
PHASE3

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

Sponsor: JSC NextGen

View on ClinicalTrials.gov

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.

Official title: "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"

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2025-02-11

Completion Date

2027-03-31

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

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

Locations (1)

Botkin Hospital

Moscow, Russia