SFDI in High Energy Lower Extremity Fracture

Completed

• Conditions: Trauma Injury
• Interventions: Procedure: Lower Extremity Surgery

• Registration Number: NCT05635617
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-15
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-11-22
• Study First Posted: 2022-12-02
• Status Verified: 2024-07
• Primary Completion: 2025-03-24
• Study Completion: 2025-03-24
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lower extremity fracture	Lower Extremity Surgery	High energy lower extremity fractures

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States