SFDI in High Energy Lower Extremity Fracture

April 29, 2025 updated by: Ida Leah Gitajn, Dartmouth-Hitchcock Medical Center

Spatial Frequency Domain Imaging-based Perfusion Imaging to Assess Soft Tissue Injury 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years of age or older who present to DHMC (Lebanon) with high energy lower leg trauma.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Upper extremity fracture
  • Metatarsal fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lower extremity fracture
High energy lower extremity fractures
Procedure: Lower Extremity Surgery
Patients 18 years of age or older with high energy lower extremity fractures. Provision of informed consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 minutes or less

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Dartmouth College

Investigators

  • Principal Investigator: Ida L Gitajn, MD, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

March 24, 2025

Study Completion (Actual)

March 24, 2025

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY02001555

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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