ICG Fluorescence Imaging in Lower Extremity Amputation Patients

Completed

• Conditions: Trauma Injury

• Registration Number: NCT04250558
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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 Timeline

• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-01-31
• Study Start: 2020-02-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Patients 18 years of age or older
2. Scheduled for a lower extremity amputation (either below knee, through knee or above knee)
3. Provision of informed consent

Exclusion Criteria

1. Iodine allergy
2. Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Bone Blood Flow (TBBF)	4 hours	Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputationas will be assessed by immunofluorescence based dynamic constrast enhanced fluorescence imaging.

Trial Locations

Locations (1)

Dartmouth-Hitchcock; 🇺🇸 Lebanon, New Hampshire, United States