Neovasculgen for unilateral neuroischemic diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• Botkin Hospital
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: Viktoria
• Email: dorozhkova.viktoria@mail.ru
• Phone: +79602952607

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.