Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients (HSI)

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.

Study Overview

• Status: Withdrawn
• Conditions: Amputation; Osteomyelitis; Foot Ulcers

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75390
      • Parkland Health and Hospital System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of the investigator scheduled for foot surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of HSI images with patient outcomes	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.	1 year

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: 3M
• Investigators: Principal Investigator: Lawrence A Lavery, DPM, MPH, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): June 13, 2014
• Primary Completion (Anticipated): June 13, 2014
• Study Completion (Actual): June 13, 2015

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Hyperspectral imaging; Foot ulcers; Foot Surgery
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Leg Ulcer; Skin Ulcer; Foot Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Infectious; Foot Ulcer; Osteomyelitis
• Other Study ID Numbers: HSI in Foot Surgery