Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-31 @ 4:43 AM
Study NCT ID:
NCT01270633
Status:
TERMINATED
Last Update Posted:
2017-12-02
First Post:
2011-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
Sponsor:
Integra LifeSciences Corporation
Organization:
Study Overview
Official Title:
A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Decision
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 compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.
Detailed Description:
Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.
Study Oversight
Has Oversight DMC:
False
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?: