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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
144
The diluted drug will be administered by 5-10 injections intramuscularly twice with an interval of 14 days, in the course dosage mode - 2.4 mg
Placebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days
Botkin Hospital
Moscow, Russia
RECRUITINGNumber of participants who achieved complete healing of the ulcer defect through study completion, an average of 6 months
Time frame: Until the end of the study
Number of participants with partial ulcer defect healing through study completion, an average of 6 months
Time frame: Until the end of the study
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