SFDI in High Energy Lower Extremity Fracture

Spatial Frequency Domain Imaging-based Perfusion Imaging to Assess Soft Tissue Injury in High Energy Lower Extremity Fracture

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05635617

Enrollment

Registered

2022-12-02

Start date

2022-08-15

Completion date

2025-03-24

Last updated

2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma Injury

Keywords

Trauma, Orthopaedic, Lower Extremity

Brief summary

This is a non-randomized prospective study of 20 patients with high energy lower extremity fractures evaluating feasibility and acceptability of SFDI, a real-time optical imaging technology.

Interventions

PROCEDURELower Extremity Surgery

Patients 18 years of age or older with high energy lower extremity fractures. Provision of informed consent.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 18 years or older * High energy lower extremity fracture * Provision of informed consent

Exclusion criteria

* Upper extremity fracture * Metatarsal fractures

Design outcomes

Primary

Measure	Time frame	Description
Feasibility and acceptability of the SFDI Imaging	4 minutes or less	The long-term objective for this research is to determine whether objective measures of perfusion through SFDI can be a predictive tool used in the ED, clinic or the operating room to determining when high-energy lower extremity fractures can safely undergo surgical fixation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026