Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455475
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-05
Brief Title:
Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
Sponsor:
Capsicure LLC
Organization:
Capsicure LLC
Study Overview
Official Title:
A Randomized Controlled Multicenter Trial Examining the Effect of Derm-Maxx ADM 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:
False
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 Derm-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 Derm-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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None