Trauma InjuryNCT04250558
ICG Fluorescence Imaging in Lower Extremity Amputation Patients
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 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure. 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 Amputation
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Consecutive patients 18 years of age or older who present to DHMC and are scheduled to undergo a lower extremity amputation (either below knee, through knee or above knee) will be considered for study enrollment.
Who may be able to join
- Patients 18 years of age or older
- Scheduled for a lower extremity amputation (either below knee, through knee or above knee)
- Provision of informed consent
Who cannot join
- Iodine allergy
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indocyanine Green Fluorescence Guided Imaging in Lower Extremity Amputation Patients
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure.
Read the detailed description
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure. The data collected in this study will inform the development of methodology and thresholds around providing surgeons with objective data regarding critically injured bone in the setting of musculoskeletal trauma and/or bone infection. This will improve our management of and decrease variation associated with management of these disabling conditions.
- Conditions
- Trauma Injury
- Being tested
- Lower Extremity Amputation
- Keywords
- Trauma, Amputation, 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 AmputationProcedure or surgery
patients 18 years of age or older who will have a planned lower leg (either below knee, through knee, or above knee) amputation surgery are scheduled to undergo a lower extremity amputation (either below knee, through knee or above knee), performed by a participating surgeon or delegate. Provision of informed consent.
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Bone Blood Flow (TBBF)-Post Osteotomy
Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputationas will be assessed by immunofluorescence based dynamic constrast enhanced fluorescence imaging.
Measured: 4 hours
Total Bone Blood Flow (TBBF)-Post Osteotomy+Stripping
Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputations will be assessed by immunofluorescence based dynamic contrast enhanced fluorescence imaging.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Feb 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- 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
- 17 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
- NCT04250558
- Sponsor's protocol ID
- D20046
- Status last verified
- May 2025
- First submitted
- 30 Jan 2020
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green Fluorescence Guided Imaging in Lower Extremity Amputation Patients
- ClinicalTrials.gov ID
- NCT04250558
- Acronym / sponsor ID
- D20046
- Conditions
- Trauma Injury
- Keywords
- Trauma, Amputation, Orthopaedic, Lower Extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 5 Jun 2025
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 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure.
Detailed description
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure. The data collected in this study will inform the development of methodology and thresholds around providing surgeons with objective data regarding critically injured bone in the setting of musculoskeletal trauma and/or bone infection. This will improve our management of and decrease variation associated with management of these disabling conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients 18 years of age or older who present to DHMC and are scheduled to undergo a lower extremity amputation (either below knee, through knee or above knee) will be considered for study enrollment.
Key inclusion criteria (3 listed)
- Patients 18 years of age or older
- Scheduled for a lower extremity amputation (either below knee, through knee or above knee)
- Provision of informed consent
Key exclusion criteria (2 listed)
- Iodine allergy
- Pregnant women
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 Amputationpatients 18 years of age or older who will have a planned lower leg (either below knee, through knee, or above knee) amputation surgery are scheduled to undergo a lower extremity amputation (either below knee, through knee or above knee), performed by a participating surgeon or delegate. Provision of informed consent. | Procedure or surgery | – |
Primary outcome
Total Bone Blood Flow (TBBF)-Post Osteotomy
Time frame: 4 hours
Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputationas will be assessed by immunofluorescence based dynamic constrast enhanced fluorescence imaging.
Total Bone Blood Flow (TBBF)-Post Osteotomy+Stripping
Time frame: 4 hours
Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputations will be assessed by immunofluorescence based dynamic contrast enhanced fluorescence imaging.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Trauma Injury
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
Recruiting
Craniomaxillofacial and Upper Extremity Allotransplantation
Face Injuries, Hand Injuries
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
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 5 Jun 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?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Bone Blood Flow (TBBF)-Post Osteotomy (time frame: 4 hours). The study lists 2 primary outcomes in all. 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 5 Jun 2025.