NCT05635617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
Last Updated

May 1, 2025

Status Verified

July 1, 2024

Enrollment Period

2.6 years

First QC Date

August 23, 2022

Last Update Submit

April 29, 2025

Conditions

Trauma Injury

Keywords

TraumaOrthopaedicLower Extremity

Outcome Measures

Primary Outcomes (1)

  • Feasibility and acceptability of the SFDI Imaging

    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

Study Arms (1)

Lower extremity fracture

High energy lower extremity fractures

Procedure: Lower Extremity Surgery

Interventions

Lower Extremity SurgeryPROCEDURE

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

Lower extremity fracture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Upper extremity fracture
  • Metatarsal fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Accidental InjuriesWounds and Injuries

Study Officials

  • Ida L Gitajn, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section Chief, Orthopaedics

Study Record Dates

First Submitted

August 23, 2022

First Posted

December 2, 2022

Study Start

August 15, 2022

Primary Completion

March 24, 2025

Study Completion

March 24, 2025

Last Updated

May 1, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)