Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618612
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial PCMP and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Prospective Randomized Controlled Modified Platform Trial Assessing the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial PCMP and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
Status:
RECRUITING
Status Verified Date:
2024-09
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:
PREPARE
Brief Summary:
This prospective multi-center randomized controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial PCMP and Standard of Care versus Standard of Care Alone in subjects with chronic DFUs
Detailed Description:
At least 170 subjects with a chronic DFU will be randomized 1411 to the SOC group PuraPly AM SOC or PuraPly XT SOC
Following screening and randomization subjects shall be seen weekly for up to 12 weeks For subjects that heal a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure
Following screening and randomization subjects shall be seen weekly for up to 12 weeks For subjects that heal a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure
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