Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients (HSI)
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|ClinicalTrials.gov Identifier: NCT03787862|
Recruitment Status : Withdrawn (PI No longer with the University)
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
To investigate novel advanced imaging techniques (hyperspectral imaging) that could enable clinicians to determine the degree and effectiveness of blood flow to tissues during surgery.
There are a number of disorders where blood flow is inadequate to provide nutrients and oxygen to tissues. Under some circumstances, surgery is required to either improve the blood flow or remove tissues that are poorly perfused. In other cases, occlusion of the blood supply to an organ is temporarily or permanently performed to minimize blood loss during a surgical procedure.
Additionally, there are disorders where the location of certain blood containing structures is important but not immediately obvious to surgeons during an operation. Knowledge of where those structures are is very important and could greatly improve the safety of various surgical procedures.
Patients of the investigator who are scheduled for foot surgery will be provided the opportunity to participate in this research. After giving informed consent, hyperspectral images will be obtained at various points during the surgical procedure.
As this technology is non-invasive, it is not expected to interfere with or change the procedure they are undergoing. Once the surgical procedure is complete, imaging will be saved to a disk for later evaluation.
100 subjects will participate in this study.
|Condition or disease|
|Foot Ulcers Osteomyelitis Amputation|
The hyperspectral imager will be turned on at various time points during surgery, to measure the spectral wavelengths of tissues. The surgery being performed will in no way be altered by the imaging device and post surgical follow-up of patients will be standard of care appropriate to the surgical procedure.
Patients will have HSI performed only during their surgery. They will not receive additional medications and will have no additional follow up. Participating in this study will not add extra appointments, procedures, or time requirements for the patient. The patient's medical record may be referenced for information after the surgery for up to one year. There are no costs to the patient for participation in this study.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients|
|Estimated Study Start Date :||June 13, 2014|
|Estimated Primary Completion Date :||June 13, 2014|
|Actual Study Completion Date :||June 13, 2015|
Hyperspectral Imaging (HSI)
Patients scheduled for foot surgery will be imaged using the HSI device. Data will be gathered from the electronic medical record for one year to determines the outcomes of the surgery, any complications, re-hosptializations, re-ulcerations or amputation.
- Correlation of HSI images with patient outcomes [ Time Frame: 1 year ]Patient video images will be correlated with individual outcomes. Patients undergoing similar procedures will then be compared in terms of surgical outcome and differences in hyperspectral imaging variables.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787862
|United States, Texas|
|Parkland Health and Hospital System|
|Dallas, Texas, United States, 75390|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Lawrence A Lavery, DPM, MPH||UT Southwestern Medical Center|