Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Diabetic Foot
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|ClinicalTrials.gov Identifier: NCT02538705|
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ulcers Related to Diabetic Foot Syndrome||Drug: Neovasculgen||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Study of Pl-vegf165 to Treat Diabetic Foot Syndrome|
|Actual Study Start Date :||August 2015|
|Actual Primary Completion Date :||January 1, 2016|
|Actual Study Completion Date :||January 1, 2016|
Other Name: pl-vegf165
- Area of diabetic foot ulcers [ Time Frame: 180 days ]To determine the ability of pl-vegf165 to facilitate and accelerate diabetic foot ulcers healing
- Transcutaneous oxygen pressure [ Time Frame: 180 days ]To determine the ability of pl-vegf165 to improve blood circulation in affected extremity by angiogenesis inducing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538705
|Human Stem Cell Institute|
|Moscow, Russian Federation|