Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05687656
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2022-12-02
Brief Title:
Sterilised Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers
Sponsor:
ConvaTec Inc
Organization:
ConvaTec Inc
Study Overview
Official Title:
A Prospective Multi-center Observational Study to Investigate the Safety and Effectiveness of Sterilized Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2024-04
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:
A Prospective Non-Randomized Multi-Center Observational Study
To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic non-healing diabetic foot ulcers DFUs
Eligible subjects will be treated with a weekly application of sterilized porcine placental ECM followed by standard of care wound therapy and offloading
To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic non-healing diabetic foot ulcers DFUs
Eligible subjects will be treated with a weekly application of sterilized porcine placental ECM followed by standard of care wound therapy and offloading
Detailed Description:
This is a prospective multi-center observational study The trial will include 30 completed subjects at three 3 experienced clinical centers in the United States The estimated enrollment period is 13 weeks After completing a screening the subjects will be enrolled and receive treatment followed for at least 12 weeks
It is expected that the majority of the subjects will be recruited from patients being seen in the Investigators practices No minors will be included in the study and it is anticipated that there will be a roughly equal representation of male and female subjects Further no subjects will be excluded because of race or ethnicity and all efforts will be made to adequately represent the study population in the area in which they are chosen
All subjects will be used for the analysis of efficacy and safety data
It is expected that the majority of the subjects will be recruited from patients being seen in the Investigators practices No minors will be included in the study and it is anticipated that there will be a roughly equal representation of male and female subjects Further no subjects will be excluded because of race or ethnicity and all efforts will be made to adequately represent the study population in the area in which they are chosen
All subjects will be used for the analysis of efficacy and safety data
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