Clinical trial NCT03787862: Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients
Official title: Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Foot Ulcers
Osteomyelitis
Amputation
Keywords: Foot ulcers
Foot Surgery
Hyperspectral imaging
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: KCI USA, Inc
First posted: 2018-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the investigator scheduled for foot surgery.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Correlation of HSI images with patient outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Lawrence A Lavery, DPM, MPH
role: PRINCIPAL_INVESTIGATOR
References: