Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 4:25 PM
Study NCT ID:
NCT04250558
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2020-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ICG Fluorescence Imaging in Lower Extremity Amputation Patients
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Study Overview
Official Title:
Indocyanine Green Fluorescence Guided Imaging in Lower Extremity Amputation Patients
Status:
COMPLETED
Status Verified Date:
2025-05
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 non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure.
Detailed Description:
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure. The data collected in this study will inform the development of methodology and thresholds around providing surgeons with objective data regarding critically injured bone in the setting of musculoskeletal trauma and/or bone infection. This will improve our management of and decrease variation associated with management of these disabling conditions.
Study Oversight
Has Oversight DMC:
True
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?: