ICG Fluorescence Imaging in Lower Extremity Amputation Patients

Trauma Injury Clinical Trial

Official title:

Indocyanine Green Fluorescence Guided Imaging in Lower Extremity Amputation Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250558
• Other study ID #: D20046
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Trauma Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Bone Blood Flow (TBBF)	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.	4 hours