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

NCT07391319 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-02-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • JSC NextGen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07391319 on ClinicalTrials.gov