The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJSC NextGen
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Neovasculgen®
DrugThe 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
DrugPlacebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: The investigational therapy group (Neovasculgen)Experimental treatment 1 intervention
Group B: The placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number 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 studySecondary outcomes
1
Number of participants with partial ulcer defect healing through study completion, an average of 6 months
Time frame
Until the end of the studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov