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NCT05635617 Clinical Trial

SFDI in High Energy Lower Extremity Fracture

Trauma Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05635617
Other study ID # STUDY02001555
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 15, 2022
Est. completion date June 2025

Study information
Verified date November 2023
Source Dartmouth-Hitchcock Medical Center
Contact Holly B Symonds
Phone 603-653-9440
Email Holly.B.Symonds@hitchcock.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 2025
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years or older - High energy lower extremity fracture - Provision of informed consent Exclusion Criteria: - Upper extremity fracture - Metatarsal fractures

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Lower Extremity Surgery
Patients 18 years of age or older with high energy lower extremity fractures. Provision of informed consent.

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (2)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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