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New treatment option for Ulcer Foot
Official title The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial
ClinicalTrials.gov ID: NCT07391319
What this study is testing
What is Neovasculgen®?
Neovasculgen® is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for ulcer foot.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join if
- Age under 18.
- Chronic ischemia of the lower limbs of non-atherosclerotic (other than diabetes mellitus) origin: vasculitis, systemic connective tissue diseases...
- 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.
See the full eligibility criteria
- 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)
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.