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

NCT07391319 | Recruiting Phase 3

• 1 other identifier: FootDiabEndocrin-05-2024
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcer Foot; Mellitus Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with partial ulcer defect healing through study completion, an average of 6 months

  Until the end of the study

Study Arms (2)

The investigational therapy group (Neovasculgen)

EXPERIMENTAL

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 placebo group

PLACEBO COMPARATOR

Placebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days

Drug: Placebo

Interventions

Neovasculgen® DRUG

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

The investigational therapy group (Neovasculgen)

Placebo DRUG

Placebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days

The placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Oxygen tension in the tissues directly adjacent to the ulcer defect area, from 20 to 45 mm Hg.
• Patients with no urgent indications for limb amputation.
• Acceptable ankle- brachial index range of 1.3-0.25.
• Patient's willingness to comply with the requirements for examination and treatment.
• Availability of written informed consent from the patient.
• Patient's consent to follow the regimen of unloading the affected area throughout the study (for patients with plantar ulcer location)

You may not qualify if:

• 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.
• Severe neuroosteoarthropathic deformity of the foot or other deformity that has a significant impact on the healing process.
• Ischemia, threatening limb loss.
• Presence of clinical signs of an infectious process in the ulcer area that is not controlled by the ongoing antibacterial therapy.
• Presence of purulent-destructive lesions of the foot (abscess, phlegmon, osteomyelitis, etc.).
• Skin changes associated with venous pathology.
• Proliferative and terminal stages of diabetic retinopathy.
• The level of glycated hemoglobin at the entrance to the study is more than 11%.
• Diabetic ketoacidosis or diabetic precoma.
• 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.
• 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.
• Planned major surgery in the next 6 months.

Sponsors & Collaborators

• JSC NextGen: lead

Study Sites (1)

Botkin Hospital

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Foot Ulcer; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Viktoria

CONTACT

+79602952607; dorozhkova.viktoria@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 5, 2026
• Study Start: February 11, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)