Trauma InjuryNCT05635617
SFDI in High Energy Lower Extremity Fracture
An observational study of Trauma Injury, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Lower Extremity Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 24 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years of age or older who present to DHMC (Lebanon) with high energy lower leg trauma.
Who may be able to join
- Age 18 years or older
- High energy lower extremity fracture
- Provision of informed consent
Who cannot join
- Upper extremity fracture
- Metatarsal fractures
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: 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.
- Conditions
- Trauma Injury
- Being tested
- Lower Extremity Surgery
- Keywords
- Trauma, Orthopaedic, Lower Extremity
- Medical subject headings
- Accidental Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Extremity SurgeryProcedure or surgery
Patients 18 years of age or older with high energy lower extremity fractures. Provision of informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Lower extremity fracture | High energy lower extremity fractures Receives: Procedure: Lower Extremity Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 minutes or less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start15 Aug 2022
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Principal investigator, Ida Leah Gitajn, Dartmouth-Hitchcock Medical Center
- Investigators
- Ida L Gitajn, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635617
- Sponsor's protocol ID
- STUDY02001555
- Status last verified
- Jul 2024
- First submitted
- 23 Aug 2022
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Frequency Domain Imaging-based Perfusion Imaging to Assess Soft Tissue Injury in High Energy Lower Extremity Fracture
- ClinicalTrials.gov ID
- NCT05635617
- Acronym / sponsor ID
- STUDY02001555
- Conditions
- Trauma Injury
- Keywords
- Trauma, Orthopaedic, Lower Extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower extremity fracture | – | Procedure: Lower Extremity SurgeryHigh energy lower extremity fractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age or older who present to DHMC (Lebanon) with high energy lower leg trauma.
Key inclusion criteria (3 listed)
- Age 18 years or older
- High energy lower extremity fracture
- Provision of informed consent
Key exclusion criteria (2 listed)
- Upper extremity fracture
- Metatarsal fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower Extremity SurgeryPatients 18 years of age or older with high energy lower extremity fractures. Provision of informed consent. | Procedure or surgery | Lower extremity fracture |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ida L Gitajn, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of the SFDI Imaging (time frame: 4 minutes or less). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.