NCT07391319 The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial
| NCT ID | NCT07391319 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | JSC NextGen |
| Condition | Ulcer Foot |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 144 participants in total. It began in 2025-02-11 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07391319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ulcer Foot. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07391319 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 144 participants.
Is NCT07391319 currently recruiting?
Yes, NCT07391319 is actively recruiting participants. Contact the research team at dorozhkova.viktoria@mail.ru for enrollment information.
Where is the NCT07391319 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07391319 clinical trial?
NCT07391319 is sponsored by JSC NextGen. The trial plans to enroll 144 participants.