Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640985
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-center Prospective Case Series Study to Determine the Efficacy and Safety of EDX110 in Hard-to-heal Wounds Resulting from Venous Insufficiency or Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds
Detailed Description:
Prospective single-center non-blinded non-randomized post-market study to determine the efficacy of EDX110 dressing system in diabetic foot ulcers DFUs and venous leg ulcers VLUs
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