Efficiency, Safety and Portability of Neovasculgen (Neovasculgen)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03068585|
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Drug: Neovasculgen (Cambiogeneplasmid)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3 Study of Efficiency, Safety and Portability of Gene Therapy Drug Neovasculgen (DNA Encoding the 165-amino-acid Isoform of Human Vascular Endothelial Growth Factor (pCMV - VEGF165) for Peripheral Arterial Disease Complex Treatment|
|Actual Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 1, 2011|
|Actual Study Completion Date :||July 1, 2011|
DNA encoding the 165-amino-acid isoform of human vascular endothelial growth factor (pCMV - VEGF165)
Drug: Neovasculgen (Cambiogeneplasmid)
Other Name: Neovasculgen
No Intervention: Control
- Pain-free walking distance. [ Time Frame: 6 months ]The PWD was determined using a treadmill test with reduced initial speed (1 km/h), as the majority of elderly patients were unable to perform Gardner test or its equivalents.
- Ankle-brachial index [ Time Frame: 6 months ]The ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). Compared to the arm, lower blood pressure in the leg is an indication of blocked arteries due to peripheral artery disease (PAD).
- Transcutaneous oximetry [ Time Frame: 6 months ]Transcutaneous oximetry, tcpO2 or TCOM, is a local, non-invasive measurement reflecting the amount of O2 that has diffused from the capillaries, through the epidermis.
- quality of life [ Time Frame: 6 months ]SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.
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): NCT03068585
|Russian National Surgery Center by Petrovsky|
|Moscow, Central Russia, Russian Federation, 119991|
|Ryazansky State Medical University|
|Ryazan, Central Russia, Russian Federation, 390026|
|Yaroslavl State Medical Academy|
|Yaroslavl, Central Russia, Russian Federation, 150000|