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"

The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial (NCT07391319) is a Phase 3 interventional studying Ulcer Foot and Mellitus Diabetes, sponsored by JSC NextGen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Ulcer Foot, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 144 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ulcer Foot subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male and female patients aged 18 years and above inclusive (at the time of study entry) with neuroischemic form of diabetic foot syndrome. 2. Type 1 or type 2 diabetes mellitus. 3. Prolonged non-healing ulcerative defect on the background of standard therapy (at least 1 month), limited to the foot. 4. Depth of ulcer defect according to Wagner Scale- 1 or 2 degrees. 5. Oxygen tension in the tissues directly adjacent to the ulcer defect area, from 20 to 45 mm Hg. 6. Patients with no urgent indications for limb amputation. 7. Acceptable ankle- brachial index range of 1.3-0.25. 8. Patient's willingness to comply with the requirements for examination and treatment. 9. Availability of written willing to sign a consent form from the patient. 10. Patient's consent to follow the regimen of unloading the affected area throughout the study (for patients with plantar ulcer location) Who Should NOT Join This Trial: 1. Age under 18. 2. Chronic ischemia of the lower limbs of non-atherosclerotic (other than diabetes mellitus) origin: vasculitis, systemic connective tissue diseases, Buerger's disease, congenital anomalies and vascular injuries, embolism. 3. Calcaneal localization of the ulcer. 4. Neuropathic form of diabetic foot syndrome. 5. Severe neuroosteoarthropathic deformity of the foot or other deformity that has a significant impact on the healing process. 6. Ischemia, threatening limb loss. 7. Presence of clinical signs of an infectious process in the ulcer area that is not controlled by the ongoing antibacterial therapy. 8. Presence of purulent-destructive lesions of the foot (abscess, phlegmon, osteomyelitis, etc.). 9. Skin changes associated with venous pathology. 10. Proliferative and terminal stages of diabetic retinopathy. 11. The level of glycated hemoglobin at the entrance to the study is more than 11%. 12. Diabetic ketoacidosis or diabetic precoma. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Male and female patients aged 18 years and above inclusive (at the time of study entry) with neuroischemic form of diabetic foot syndrome. 2. Type 1 or type 2 diabetes mellitus. 3. Prolonged non-healing ulcerative defect on the background of standard therapy (at least 1 month), limited to the foot. 4. Depth of ulcer defect according to Wagner Scale- 1 or 2 degrees. 5. Oxygen tension in the tissues directly adjacent to the ulcer defect area, from 20 to 45 mm Hg. 6. Patients with no urgent indications for limb amputation. 7. Acceptable ankle- brachial index range of 1.3-0.25. 8. Patient's willingness to comply with the requirements for examination and treatment. 9. Availability of written informed consent from the patient. 10. Patient's consent to follow the regimen of unloading the affected area throughout the study (for patients with plantar ulcer location) Exclusion Criteria: 1. Age under 18. 2. Chronic ischemia of the lower limbs of non-atherosclerotic (other than diabetes mellitus) origin: vasculitis, systemic connective tissue diseases, Buerger's disease, congenital anomalies and vascular injuries, embolism. 3. Calcaneal localization of the ulcer. 4. Neuropathic form of diabetic foot syndrome. 5. Severe neuroosteoarthropathic deformity of the foot or other deformity that has a significant impact on the healing process. 6. Ischemia, threatening limb loss. 7. Presence of clinical signs of an infectious process in the ulcer area that is not controlled by the ongoing antibacterial therapy. 8. Presence of purulent-destructive lesions of the foot (abscess, phlegmon, osteomyelitis, etc.). 9. Skin changes associated with venous pathology. 10. Proliferative and terminal stages of diabetic retinopathy. 11. The level of glycated hemoglobin at the entrance to the study is more than 11%. 12. Diabetic ketoacidosis or diabetic precoma. 13. Systemic use of glucocorticosteroids and/or other immunosuppressive drugs within the last 30 days before inclusion in the study. 14. Recent (less than 1 month) surgery or endovascular intervention on the arteries of the lower extremities or recent (less than 1 month) deep vein thrombosis of the lower extremities. 15. Recent (less than 3 months) cases of acute myocardial infarction, unstable angina, coronary artery bypass grafting or stenting of the coronary arteries, stroke or transient ischemic attacks. 16. Planned major surgery in the next 6 months. 17. Severe concomitant disease with life expectancy less than one year. 18. Infectious diseases, septic conditions, HIV infection. 19. Diagnosis of cancer within the last 5 years. 20. Pregnancy, breastfeeding period. 21. Positive pregnancy test in women of reproductive age. 22. Alcohol or drug addiction. 23. Any other disease (including mental) or clinical condition that, in the opinion of the researcher, may affect the patient's ability to participate in the study.

Treatments Being Tested

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Botkin Hospital

Moscow, Russia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07391319), the sponsor (JSC NextGen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07391319 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07391319?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07391319?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07391319. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07391319. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.