NCT04250558

ICG Fluorescence Imaging in Lower Extremity Amputation Patients

Indocyanine Green Fluorescence Guided Imaging in Lower Extremity Amputation Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma Injury

Interventions

Type	Name	Description
PROCEDURE	Lower Extremity Amputation	patients 18 years of age or older who will have a planned lower leg (either below knee, through knee, or above knee) amputation surgery are scheduled to undergo a lower extremity amputation (either below knee, through knee or above knee), performed by a participating surgeon or delegate. Provision of informed consent.

Timeline

• Start date: 2020-02-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2020-01-31
• Last updated: 2025-06-05
• Results posted: 2025-06-05

Locations

1 site across 1 country: United States