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