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Completed

NCT Number: NCT05635617

SFDI in High Energy Lower Extremity Fracture

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.

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Key information

Conditions

Trauma Injury Accidental Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Upper extremity fracture
  • Metatarsal fractures

Treatment and study plan

Lower Extremity Surgery

Procedure

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

Primary outcomes

  1. Feasibility and acceptability of the SFDI Imaging

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2022
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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