Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04537520
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2020-08-25
Brief Title:
Interventional Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Diabetic Foot Wounds
Sponsor:
Centre dEtudes et de Recherche pour lIntensification du Traitement du Diabète
Organization:
Centre dEtudes et de Recherche pour lIntensification du Traitement du Diabète
Study Overview
Official Title:
Interventional Multi-Center Post Market Randomized Controlled Open-Label Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Hard to Heal Diabetic Foot Wounds
Status:
COMPLETED
Status Verified Date:
2023-02
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:
KereFish
Brief Summary:
The KereFish study is a randomized controlled study to study the efficacy of Kerecis Omega3 Wound on deep diabetic ulcers This study is probably the first in his field in this one the Kerecis Omega3 Wound dies are used on the types of wounds for which they are ultimately intended This study aims to document the cost benefits of earlier closure of severe diabetic wounds or the change of the deep and chronic wound into a smaller and shallower ulcer and to radically alter its prognosis The study carried out in France uses the pre-existing home nursing system with the transmission of photographs to the reference centre The study was largely designed to ensure transparency of the financial calculations involved
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None