Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568627
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-04
Brief Title:
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU VALUE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Prospective Randomized Double Blind Placebo Controlled Adaptive Design Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of Venous Leg Ulcers VALUE
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:
VALUE
Brief Summary:
The main objective of this study is
To assess the efficacy and safety of EscharEx EX-03 5 formulation compared to placebo controlin debridement and wound bed preparation of Venous Leg Ulcers VLU
To assess the efficacy and safety of EscharEx EX-03 5 formulation compared to placebo controlin debridement and wound bed preparation of Venous Leg Ulcers VLU
Detailed Description:
At least 216 eligible adult patients with VLU with a surface area between 2 cm2 and 25 cm2 and wound age between 4 weeks and 12 months will be randomized The patients will be treated with IMP either EX-03 5 or placebo in a double blinded manner
Total duration of the study is up to 27 weeks
1 Screening period 2 visits 7 days apart
2 Daily Visits Period - Debridement with IMP up to 8 daily site visits within up to 2 weeks
3 Weekly Visits Period - wound management up to 11 visits within up to 10 weeks optional wound closure confirmation up to 2 weeks Wound will be managed in a standardized manner
4 Monthly Visits Period - Wound Closure Durability Period of 12 weeks starting after wound closure confirmation 3 visits within 12 weeks per formed only for wound closed during weekly visits period
Total duration of the study is up to 27 weeks
1 Screening period 2 visits 7 days apart
2 Daily Visits Period - Debridement with IMP up to 8 daily site visits within up to 2 weeks
3 Weekly Visits Period - wound management up to 11 visits within up to 10 weeks optional wound closure confirmation up to 2 weeks Wound will be managed in a standardized manner
4 Monthly Visits Period - Wound Closure Durability Period of 12 weeks starting after wound closure confirmation 3 visits within 12 weeks per formed only for wound closed during weekly visits period
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