Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304837
Status:
COMPLETED
Last Update Posted:
2010-10-19
First Post:
2006-03-16
Brief Title:
VEGF Gene Transfer for Critical Limb Ischemia
Sponsor:
Losordo Douglas MD
Organization:
Losordo Douglas MD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor VEGF or placebo in patients with moderate to high-risk Critical Limb Ischemia a condition in which there is poor blood circulation in the leg This trial will assess whether VEGF improves rest pain andor heals ulcers in the legs of patients with peripheral artery disease blockages in leg arteries
VEGF is DNA or genetic material that will be injected into the leg muscles on three separate occasions each 2 weeks apart Once the DNA is in the leg it directs the cells of the artery wall to increase its production of VEGF which has been shown to cause new blood vessels to grow This experimental therapy is designed to grow new blood vessels around blockages in the leg arteries
The total length of participation in this study is approximately 1 year and will require approximately 8 clinic visits within that year Following enrollment in the study testing may be done for cancer screening blood work physical exams vascular testing and eye exams There is no charge for any testing or office visits required by the study
This study has been approved by the Food and Drug Administration FDA
VEGF is DNA or genetic material that will be injected into the leg muscles on three separate occasions each 2 weeks apart Once the DNA is in the leg it directs the cells of the artery wall to increase its production of VEGF which has been shown to cause new blood vessels to grow This experimental therapy is designed to grow new blood vessels around blockages in the leg arteries
The total length of participation in this study is approximately 1 year and will require approximately 8 clinic visits within that year Following enrollment in the study testing may be done for cancer screening blood work physical exams vascular testing and eye exams There is no charge for any testing or office visits required by the study
This study has been approved by the Food and Drug Administration FDA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None