Trial Outcomes & Findings for ICG Fluorescence Imaging in Lower Extremity Amputation Patients (NCT NCT04250558)

NCT ID: NCT04250558

Last Updated: 2025-06-05

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 17 participants
• Primary outcome timeframe: 4 hours
• Results posted on: 2025-06-05

Participant Flow

Participant milestones

Measure	Extremity Amputation Patients over 18 undergoing lower extremity amputation
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ICG Fluorescence Imaging in Lower Extremity Amputation Patients

Baseline characteristics by cohort

Measure	Extremity Amputation n=15 Participants Patients over 18 undergoing either below knee, through knee, or above knee lower extremity amputation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Total Bone Blood Flow	6.7 mL/min/100g n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Extremity Amputation n=15 Participants Patients over 18 undergoing either below knee, through knee, or above knee lower extremity amputation.
Total Bone Blood Flow (TBBF)-Post Osteotomy	4.9 mL/min/100g Interval 0.0 to 30.0

PRIMARY outcome

Timeframe: 4 hours

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.

Outcome measures

Measure	Extremity Amputation n=15 Participants Patients over 18 undergoing either below knee, through knee, or above knee lower extremity amputation.
Total Bone Blood Flow (TBBF)-Post Osteotomy+Stripping	0.8 mL/min/100g Interval 0.0 to 30.0

Adverse Events

Extremity Amputation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ida Leah Gitajn

Dartmouth Hitchcock Medical Center

Phone: (603) 650-5133

Email: ida.leah.gitajn@hitchcock.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place