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Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients

NCT ID: NCT03787862

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-13

Study Completion Date

2015-06-13

Brief Summary

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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

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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.

Conditions

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Foot Ulcers Osteomyelitis Amputation

Keywords

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Foot ulcers Foot Surgery Hyperspectral imaging

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KCI USA, Inc

INDUSTRY

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lawrence A Lavery, DPM, MPH

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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Parkland Health and Hospital System

Dallas, Texas, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSI in Foot Surgery

Identifier Type: -

Identifier Source: org_study_id