N/A
Completed N=15
ICG Fluorescence Imaging in Lower Extremity Amputation Patients
Trauma Injury
Source: ClinicalTrials.gov NCT04250558 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Total Bone Blood Flow (TBBF)-Post Osteotomy — 4.9 mL/min/100g
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.
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 |
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. Informational only — not medical advice.