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

"Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Study of the Efficacy and Safety of the Drug Neovasculgen® Lyophilisate for the Preparation of a Solution for Intramuscular Administration 1.2 mg", Manufacturer Federal State Budgetary Institution "NMITs of Hematology" of the Ministry of Health of the Russian Federation, Russia in Patients With Diabetic Foot Syndrome"

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 Overview

• Status: Recruiting
• Conditions: Ulcer Foot; Mellitus Diabetes
• Intervention / Treatment: Drug: Neovasculgen®; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Viktoria; Phone Number: +79602952607; Email: dorozhkova.viktoria@mail.ru

Study Locations

• Russia
  • Moscow, Russia
    • Recruiting
    • Botkin Hospital
    • Contact: Surgeon; Phone Number: +79602952607; Email: dorozhkova.viktoria@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 than diabetes mellitus) origin: vasculitis, systemic connective tissue diseases, Buerger's disease, congenital anomalies and vascular injuries, embolism.
3. Calcaneal localization of the ulcer.
4. Neuropathic form of diabetic foot syndrome.
5. Severe neuroosteoarthropathic deformity of the foot or other deformity that has a significant impact on the healing process.
6. Ischemia, threatening limb loss.
7. Presence of clinical signs of an infectious process in the ulcer area that is not controlled by the ongoing antibacterial therapy.
8. Presence of purulent-destructive lesions of the foot (abscess, phlegmon, osteomyelitis, etc.).
9. Skin changes associated with venous pathology.
10. Proliferative and terminal stages of diabetic retinopathy.
11. The level of glycated hemoglobin at the entrance to the study is more than 11%.
12. Diabetic ketoacidosis or diabetic precoma.
13. Systemic use of glucocorticosteroids and/or other immunosuppressive drugs within the last 30 days before inclusion in the study.
14. 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.
15. 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.
16. Planned major surgery in the next 6 months.
17. Severe concomitant disease with life expectancy less than one year.
18. Infectious diseases, septic conditions, HIV infection.
19. Diagnosis of cancer within the last 5 years.
20. Pregnancy, breastfeeding period.
21. Positive pregnancy test in women of reproductive age.
22. Alcohol or drug addiction.
23. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The investigational therapy group (Neovasculgen); 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.	Drug: Neovasculgen®; 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 Comparator: The placebo group; Placebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days	Drug: Placebo; Placebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants who achieved complete healing of the ulcer defect through study completion, an average of 6 months	Until the end of the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with partial ulcer defect healing through study completion, an average of 6 months	Until the end of the study

Collaborators and Investigators

• Sponsor: JSC NextGen

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Skin Diseases; Skin Ulcer; Leg Ulcer; Foot Diseases; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Foot Ulcer
• Other Study ID Numbers: FootDiabEndocrin-05-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No