Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444906
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-30
Brief Title:
A Two-Part Randomized Study of Dermacyte Amniotic Wound Care Matrix
Sponsor:
Merakris Therapeutics
Organization:
Merakris Therapeutics
Study Overview
Official Title:
A Two-Part Randomized Study of Dermacyte Amniotic Wound Care Matrix for the Treatment of Diabetic Foot Ulcers DFU
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 is a multi-center prospective two-part controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or SOC
Detailed Description:
This is a multi-center prospective two-part controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or standard of care SOC
Part 1 of the study will enroll 20 participants to determine the percentage of participants with a complete ulcer closure following treatment with Dermacyte Matrix at Week 12
In Part 2 of the study approximately 65 participants will be randomized 11 to receive Dermacyte Matrix or SOC for 12 weeks The final sample size for Part 2 may be adjusted based on the effect size observed in Part 1 of the study
For the purposes of this study SOC therapy will consist of debridement of nonviable tissue saline-moistened non-occlusive dressing weight off-loading to decrease pressure on extremity aggressive treatment of infection and arterial revascularization if indicated
Part 1 of the study will enroll 20 participants to determine the percentage of participants with a complete ulcer closure following treatment with Dermacyte Matrix at Week 12
In Part 2 of the study approximately 65 participants will be randomized 11 to receive Dermacyte Matrix or SOC for 12 weeks The final sample size for Part 2 may be adjusted based on the effect size observed in Part 1 of the study
For the purposes of this study SOC therapy will consist of debridement of nonviable tissue saline-moistened non-occlusive dressing weight off-loading to decrease pressure on extremity aggressive treatment of infection and arterial revascularization if indicated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None