Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Diabetic Foot

Study Overview
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Brief Summary
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The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of ulcers related to diabetic foot syndrome

Detailed Description
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This is a open clinical trial assessing the therapeutic efficacy of pl-vegf165 (Neovasculgen) in treating ulcers related to diabetic foot syndrome. Each patient will undergo several intramuscular injections with a treatment dose of pl-vegf165 (Neovasculgen) in calf of affected extrimity. Study participants at the first study visit will complete study questionnaires, their foots will be assessed clinically for ulceration. After this initial assessment, the patients will undergo intramuscular injections of pl-vegf165 (Neovasculgen) in a calf altered with ulcers due to diabetic foot syndrome. At three month post-injection, the patient will complete study questionnaires, their foots will be assessed clinically for ulceration, and their foots will undergo non-invasive transcutaneous oximetry measurement. At six months post-injection, the patient will again complete study questionnaires, their foots will be assessed clinically for ulceration and will undergo non-invasive transcutaneous oximetry measurement.

Official Title
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Safety and Efficacy Study of Pl-vegf165 to Treat Diabetic Foot Syndrome

Conditions
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Ulcers Related to Diabetic Foot Syndrome

Intervention / Treatment
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* Drug: Neovasculgen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obtained voluntary informed consent for participation in the clinical study presence of diabetic foot syndrome presence at least one active ulcer at baseline Exclusion Criteria: Any disease that can, in the opinion of the treating physician, affect the outcome of the study Patients with addictive disorders or substance abuse Pregnancy or nursing All other exclusion criteria listed in the summary of product characteristics (SmPC)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neovasculgen<br> | Drug: Neovasculgen<br> <br> * Other names: pl-vegf165;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of diabetic foot ulcers | To determine the ability of pl-vegf165 to facilitate and accelerate diabetic foot ulcers healing | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcutaneous oxygen pressure | To determine the ability of pl-vegf165 to improve blood circulation in affected extremity by angiogenesis inducing | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot syndrome, Ulcers