Ulcer FootPhase 3NCT07391319
The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial
A Phase 3 study testing Neovasculgen® in people with Ulcer Foot and Mellitus Diabetes, run by JSC NextGen at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer Foot, Mellitus Diabetes
- What is being tested?
- Neovasculgen®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteRussia
- Study dates
- 11 Feb 2025to 31 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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.
- Systemic use of glucocorticosteroids and/or other immunosuppressive drugs within the last 30 days before inclusion in the study.
- 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.
- Severe concomitant disease with life expectancy less than one year.
- Infectious diseases, septic conditions, HIV infection.
- Diagnosis of cancer within the last 5 years.
- Pregnancy, breastfeeding period.
- Positive pregnancy test in women of reproductive age.
- Alcohol or drug addiction.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Botkin Hospital
Moscow
Surgeon, +79602952607, dorozhkova.viktoria@mail.ru
About this study
Official title: "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.
- Conditions
- Ulcer Foot, Mellitus Diabetes
- Being tested
- Neovasculgen®, Placebo
- Medical subject headings
- Foot Ulcer, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDrug
Placebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Neovasculgen® |
| The placebo group | Placebo comparator | Placebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who achieved complete healing of the ulcer defect through study completion, an average of 6 months
Measured: 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
Measured: Until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start11 Feb 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcer FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JSC NextGen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391319
- Sponsor's protocol ID
- FootDiabEndocrin-05-2024
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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"
- ClinicalTrials.gov ID
- NCT07391319
- Acronym / sponsor ID
- FootDiabEndocrin-05-2024
- Conditions
- Ulcer Foot, Mellitus Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- JSC NextGenUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The investigational therapy group (Neovasculgen) | Experimental | 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. |
| The placebo group | Placebo comparator | Drug: PlaceboPlacebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | The investigational therapy group (Neovasculgen) |
| PlaceboPlacebo will be administered by 5-10 injections intramuscularly twice with an interval of 14 days | Drug | The placebo group |
Primary outcome
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 study
1 secondary outcome
Number of participants with partial ulcer defect healing through study completion, an average of 6 months
Time frame: Until the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neovasculgen® in people with Ulcer Foot and Mellitus Diabetes, run by JSC NextGen at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viktoria (+79602952607, dorozhkova.viktoria@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.