N/A
N=15
ICG Fluorescence Imaging in Lower Extremity Amputation Patients
Trauma Injury
Bottom Line
View on ClinicalTrials.gov: NCT04250558 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Total Bone Blood Flow (TBBF)-Post Osteotomy — 4.9 mL/min/100g
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lower Extremity Amputation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Bone Blood Flow (TBBF)-Post Osteotomy |
4.9 | — |
| PRIMARY Total Bone Blood Flow (TBBF)-Post Osteotomy+Stripping |
0.8 | 0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Iodine allergy
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT04250558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.