Neovasculgen for unilateral neuroischemic diabetic foot ulcers

"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"

This trial tests whether a single 2.4 mg course of Neovasculgen plus standard care can help adults with unilateral neuroischemic diabetic foot ulcers heal better and stay safe compared with a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: JSC NextGen (Academic / other)
• Locations: 1 site (Moscow)
• Trial ID: NCT07391319 on ClinicalTrials.gov

What this trial studies

This is a phase 3, randomized, double-blind, placebo-controlled multicenter trial comparing a 2.4 mg course of Neovasculgen plus standard drug therapy versus placebo in patients with unilateral neuroischemic diabetic foot syndrome. Eligible adults have type 1 or type 2 diabetes with a chronic non-healing foot ulcer (Wagner grade 1–2) and tissue oxygen tension of 20–45 mm Hg, and must tolerate offloading. The study measures efficacy and safety outcomes, focusing on ulcer healing and limb preservation while monitoring adverse events. Participants are randomized to receive either Neovasculgen or placebo in addition to their usual care and are followed per protocol at the study site(s).

Who should consider this trial

Good fit: Adults (18+) with type 1 or 2 diabetes who have a unilateral neuroischemic foot ulcer of Wagner grade 1–2, tissue oxygen 20–45 mm Hg, an ankle-brachial index between 0.25 and 1.3, and who can follow offloading and attend study visits are ideal candidates.

Not a fit: Patients with more severe wounds (Wagner >2), urgent indications for amputation, non-neuroischemic or non-atherosclerotic causes of limb ischemia, tissue oxygen outside 20–45 mm Hg, or who cannot travel to the study site are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the treatment could improve ulcer healing and reduce the risk of limb loss for people with neuroischemic diabetic foot.

How similar studies have performed: Prior smaller studies of Neovasculgen and other therapeutic angiogenesis approaches have shown promising signals in peripheral arterial disease, but large randomized phase 3 evidence specifically for diabetic foot ulcers remains limited.

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.

Where this trial is running

Moscow

• Botkin Hospital — Moscow, Russia (Recruiting)

Study contacts

• Study coordinator: Viktoria

Conditions Ulcer Foot; Mellitus Diabetes