Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01475786
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2011-11-15
Brief Title:
Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy
Sponsor:
Helixmith Co Ltd
Organization:
Helixmith Co Ltd
Study Overview
Official Title:
A Phase II Double-Blind Randomized Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of Engensis VM202 in Subjects With Painful Diabetic Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if Engensis VM202 is safe and effective in treating painful diabetic neuropathy
Detailed Description:
Peripheral neuropathy is a serious complication of diabetes This form of neuropathy carries a high risk of pain trophic changes and autonomic dysfunction There is currently no effective treatment for diabetic neuropathy and good glycemic control is the only way to minimize the risk of occurrence Clearly it would be desirable to prevent impede or reverse the disrupting and often life-threatening manifestations of peripheral neuropathy by stimulating growth or regeneration of peripheral nerve axons
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