Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470087
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2024-05-31
Brief Title:
High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human AmnionChorion Membrane in Treatment of DFUs
Sponsor:
Adichunchanagiri Institute of Medical Sciences B G Nagara
Organization:
Adichunchanagiri Institute of Medical Sciences B G Nagara
Study Overview
Official Title:
A Randomized Controlled Clinical Trial Comparing High Purity Type-I Collagen-based Skin Substitute to Dehydrated Human AmnionChorion Membrane in the Treatment of Diabetic Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2024-10
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:
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and Standard of Care with Dehydrated Human AmnionChorion Membrane
Detailed Description:
The purpose of this randomized controlled clinical study is to collect and compare patient outcome data at 4 weeks using Type-I Collagen-based Skin Substitute in one half of the patients and Dehydrated Human AmnionChorion Membrane in the other half
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None