ICG Fluorescence Imaging in Lower Extremity Amputation Patients

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04250558
• Collaborator: Dartmouth College (Other)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Injury	Procedure: Lower Extremity Amputation

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 Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Indocyanine Green Fluorescence Guided Imaging in Lower Extremity Amputation Patients
• Actual Study Start Date: Feb 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jan 31, 2023

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcock	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center
• Dartmouth College

Investigators

• Principal Investigator: Ida L Gitajn, MD, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ida Leah Gitajn, Staff Physician, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT04250558
• Other Study ID Numbers: D20046
• First Posted: Jan 31, 2020
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ida Leah Gitajn, Staff Physician, Dartmouth-Hitchcock Medical Center: Trauma; Amputation; Orthopaedic; Lower Extremity

Study Results

No Results Posted as of Aug 24, 2022