ICG Fluorescence Imaging in Lower Extremity Amputation Patients

NCT04250558 | Completed Results DMC

• 1 other identifier: D20046
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Injury

Keywords

Trauma; Amputation; Orthopaedic; Lower Extremity

Outcome Measures

Primary Outcomes (2)

• Total Bone Blood Flow (TBBF)-Post Osteotomy

  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

• Total Bone Blood Flow (TBBF)-Post Osteotomy+Stripping

  Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputations will be assessed by immunofluorescence based dynamic contrast enhanced fluorescence imaging.

  4 hours

Interventions

Lower Extremity Amputation PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients 18 years of age or older who present to DHMC and are scheduled to undergo a lower extremity amputation (either below knee, through knee or above knee) will be considered for study enrollment.

You may qualify if:

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

You may not qualify if:

• Iodine allergy
• Pregnant women

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Accidental Injuries; Wounds and Injuries

Results Point of Contact

• Title: Dr. Ida Leah Gitajn
• Organization: Dartmouth Hitchcock Medical Center

ida.leah.gitajn@hitchcock.org

(603) 650-5133

Study Officials

• Ida L Gitajn, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: January 31, 2020
• Study Start: February 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)