Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:31 AM
Study NCT ID:
NCT06103812
Status:
UNKNOWN
Last Update Posted:
2023-10-27
First Post:
2023-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Performance and Safety of Hyalo4 Skin in Acute and Chronic Wounds
Sponsor:
Fidia Farmaceutici s.p.a.
Organization:
Study Overview
Official Title:
Prospective, Multicentric, Observational Clinical Investigation to Evaluate the Performance and Safety of Hyalo4 Skin Gel in Management of Acute and Chronic Wounds.
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
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:
Evaluate the performance and safety of the use of Hyalo4 Skin Gel in terms of wound management
Detailed Description:
Ths clinical investigation study is to evaluate the performance and safety of Hyalo4 Skin Gel in the management of acute or chronic wounds of different etiology, according to the indication for use, the prescriptions of the clinicians and the standard procedures of the sites.
A maximum of 7 Visits will be performed, with the first 4 visits performed over a 4-weeks period for each patient and the last visit after 8 weeks from the first visit.
The schedule treatment will consist of daily medication changes, according to the instruction for use and the clinical practice.
A maximum of 7 Visits will be performed, with the first 4 visits performed over a 4-weeks period for each patient and the last visit after 8 weeks from the first visit.
The schedule treatment will consist of daily medication changes, according to the instruction for use and the clinical practice.
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?: