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

Inclusion criteria

• Male and female patients aged 18 years and above inclusive (at the time of study entry) with neuroischemic form of diabetic foot syndrome.
• Type 1 or type 2 diabetes mellitus.
• Prolonged non-healing ulcerative defect on the background of standard therapy (at least 1 month), limited to the foot.
• Depth of ulcer defect according to Wagner Scale- 1 or 2 degrees.
• Oxygen tension in the tissues directly adjacent to the ulcer defect area, from 20 to 45 mm Hg.
• Patients with no urgent indications for limb amputation.
• Acceptable ankle- brachial index range of 1.3-0.25.
• Patient's willingness to comply with the requirements for examination and treatment.
• Availability of written informed consent from the patient.
• Patient's consent to follow the regimen of unloading the affected area throughout the study (for patients with plantar ulcer location)

Exclusion criteria

• Age under 18.
• 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.
• Calcaneal localization of the ulcer.
• Neuropathic form of diabetic foot syndrome.
• Severe neuroosteoarthropathic deformity of the foot or other deformity that has a significant impact on the healing process.
• Ischemia, threatening limb loss.
• Presence of clinical signs of an infectious process in the ulcer area that is not controlled by the ongoing antibacterial therapy.
• Presence of purulent-destructive lesions of the foot (abscess, phlegmon, osteomyelitis, etc.).
• Skin changes associated with venous pathology.
• Proliferative and terminal stages of diabetic retinopathy.
• The level of glycated hemoglobin at the entrance to the study is more than 11%.
• Diabetic ketoacidosis or diabetic precoma.
• Systemic use of glucocorticosteroids and/or other immunosuppressive drugs within the last 30 days before inclusion in the study.
• 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.
• 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.
• Planned major surgery in the next 6 months.
• Severe concomitant disease with life expectancy less than one year.
• Infectious diseases, septic conditions, HIV infection.
• Diagnosis of cancer within the last 5 years.
• Pregnancy, breastfeeding period.
• Positive pregnancy test in women of reproductive age.
• Alcohol or drug addiction.
• 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.