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Clinical trial

A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs

NCT07046767 is registered in ClinicalTrials.gov with Capsicure, LLC as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs
Lead sponsor
Capsicure, LLC
Phase
Not applicable
Overall status
Recruiting
Start date
October 1, 2025
Completion date
July 20, 2026
Enrollment
165 (estimated)
Sites
7

Conditions

As the registry lists them; a condition with its own page is linked.

diabetic foot ulcer (dfu), venous leg ulcer, wound; foot