Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572839
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Amnio-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Multicenter Trial Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 randomized controlled study evaluates the adjuvant use of Amnio-Maxx in patients with diabetic foot ulcers
Detailed Description:
This is a multicenter randomized open-label clinical study in patients with Wagner grade 1 and 2 DFUs Diabetic patients presenting with chronic nonhealing ulcers will be screened for eligibility At least 50 of the eligible population will be drawn from patients 65 years of age All patients will complete a 2-week run-in period prior to treatment allocation to Amnio-Maxx and standard of care SOC or SOC alone Patients will be seen at weekly intervals 3 days for the 12 weeks treatment period If additional dressing changes are required between the scheduled visits the occurrence of these visits will be recorded Primary efficacy endpoints include percentage change in ulcer size at 12 weeks along with the proportion of participants achieving complete wound closure Additionally pain and safety will be assessed as secondary endpoints
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