Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598241
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Mirragen Diabetic Foot Ulcer Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Post-market Non-interventional Prospective Observational Study of Standard of Care of the Commercially Available Borate-base Bioactive Glass Fiber Matrix BBGFM in Treatment of Outpatient Diabetic Foot Ulcer With Chronic Osteomyelitis
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This study is being done to collect data from treatment of patients who have diabetes with non-healing foot wounds and are being treated with a resorbable and biocompatible borate-based bioactive glass fiber matrix A borate-based bioactive glass fiber matrix is used to cover the ulcer for wound management The primary objective of this study is to evaluate the safety and efficacy of the borate-based bioactive glass fiber matrix in the treatment of diabetic foot ulcers in a real-world setting The secondary objective is to evaluate the clinical and financial benefits in terms of quality of healing pain and treatment cost
Detailed Description:
While participants are taking part in this study they will be asked to attend approximately 12 weekly visits or until the ulcer has healed After the ulcer has healed there will be two follow up visits for confirmation these visits are two weeks apart Visits with the researchers andor study staff will last for 16 weeks or less Participants will continue and complete regular follow-up visit with their treating doctor while participating in this study
The purpose of this study is to collect information about the product safety and efficacy of real-world scenarios on treating diabetic foot ulcers The data that will be collected will help understand long-term risk and benefit from a real-world population
The purpose of this study is to collect information about the product safety and efficacy of real-world scenarios on treating diabetic foot ulcers The data that will be collected will help understand long-term risk and benefit from a real-world population
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