RecruitingPhase 3NCT07391319

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"


Sponsor

JSC NextGen

Enrollment

144 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Neovasculgen® and a drug called Placebo for people with mellitus diabetes and ulcer foot. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeovasculgen®

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

DRUGPlacebo

Placebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days


Locations(1)

Botkin Hospital

Moscow, Russia

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NCT07391319


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