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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower Extremity Amputation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ida L Gitajn, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock | Lebanon | New Hampshire | 03756 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Extremity Amputation | Patients over 18 undergoing lower extremity amputation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Extremity Amputation | Patients over 18 undergoing either below knee, through knee, or above knee lower extremity amputation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | mL/min/100g | 4 hours |
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0-30 minutes post infusion
Per clinicaltrials.gov defintions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extremity Amputation | Patients over 18 undergoing either below knee, through knee, or above knee lower extremity amputation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ida Leah Gitajn | Dartmouth Hitchcock Medical Center | (603) 650-5133 | ida.leah.gitajn@hitchcock.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2022 | May 13, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| D014947 | Wounds and Injuries |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Total Bone Blood Flow | measured as mL/min/100g | Median | Full Range | mL/min/100g |
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| Primary | 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. | Posted | Median | Full Range | mL/min/100g | 4 hours |
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| 15 |
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| 15 |
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