Actively Recruiting
The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial
Led by JSC NextGen · Updated on 2026-02-05
144
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 years and above inclusive with neuroischemic diabetic foot syndrome
- Diagnosis of type 1 or type 2 diabetes mellitus
- Presence of a non-healing ulcerative defect on the foot lasting at least 1 month despite standard therapy
- Ulcer depth of Wagner Scale 1 or 2 degrees
- Oxygen tension near the ulcer between 20 and 45 mm Hg
- No urgent need for limb amputation
- Ankle-brachial index between 0.25 and 1.3
- Willingness to comply with examination and treatment requirements
- Signed informed consent
- Agreement to unload the affected area throughout the study if the ulcer is on the plantar surface
You will not qualify if you...
- Age under 18 years
- Chronic lower limb ischemia from non-atherosclerotic causes such as vasculitis, connective tissue diseases, Buerger's disease, congenital anomalies, vascular injuries, or embolism
- Ulcer located on the heel (calcaneal)
- Neuropathic diabetic foot syndrome
- Severe foot deformities affecting healing
- Ischemia threatening limb loss
- Uncontrolled infection in the ulcer area
- Purulent-destructive foot lesions like abscess, phlegmon, or osteomyelitis
- Skin changes due to venous pathology
- Proliferative or terminal diabetic retinopathy
- Glycated hemoglobin level above 11% at study entry
- Diabetic ketoacidosis or precoma
- Use of systemic glucocorticosteroids or immunosuppressants within 30 days before study
- Recent surgery or vascular intervention on lower extremities within 1 month
- Recent deep vein thrombosis of lower extremities within 1 month
- Recent acute myocardial infarction, unstable angina, coronary artery bypass or stenting, stroke, or transient ischemic attacks within 3 months
- Planned major surgery within 6 months
- Severe illness with life expectancy less than one year
- Infectious diseases including HIV
- Cancer diagnosis within last 5 years
- Pregnancy or breastfeeding
- Positive pregnancy test in women of childbearing age
- Alcohol or drug addiction
- Any other disease or condition that may affect participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Botkin Hospital
Moscow, Russia
Actively Recruiting
Research Team
V
Viktoria
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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