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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Recruitment Status : Withdrawn (PI No longer with the University)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
Sponsor:
Collaborator:
KCI USA, Inc.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

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

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of the investigator scheduled for foot surgery.
Criteria

Inclusion Criteria:

  • Male and female patients
  • 18 years or older undergoing foot surgery
  • Speak and read English or Spanish.
  • Able to provide written informed consent.

Exclusion Criteria:

  • Patients unable to give written informed consent
  • Patients who cannot speak and read English or Spanish will be excluded.

Information from the National Library of Medicine

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


Locations
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United States, Texas
Parkland Health and Hospital System
Dallas, Texas, United States, 75390
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
KCI USA, Inc.
Investigators
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Principal Investigator: Lawrence A Lavery, DPM, MPH UT Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03787862     History of Changes
Other Study ID Numbers: HSI in Foot Surgery
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

Keywords provided by University of Texas Southwestern Medical Center:
Foot ulcers
Foot Surgery
Hyperspectral imaging

Additional relevant MeSH terms:
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Osteomyelitis
Foot Ulcer
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases