ICG Fluorescence Imaging in Lower Extremity Amputation Patients

Overview

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.

Full Title of Study: “Indocyanine Green Fluorescence Guided Imaging in Lower Extremity Amputation Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Total Bone Blood Flow (TBBF)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dartmouth-Hitchcock Medical Center
  • Collaborator
    • Dartmouth College
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ida Leah Gitajn, Staff Physician – Dartmouth-Hitchcock Medical Center
  • Overall Official(s)
    • ida l gitajm, MD, Principal Investigator, Dartmouth-Hitchcock Medical Center
  • Overall Contact(s)
    • Amy E Hall, MS, 6036533306, amy.e.hall@hitchcock.org

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