Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients

NCT03787862 | Withdrawn

• 1 other identifier: HSI in Foot Surgery
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Foot Ulcers; Osteomyelitis; Amputation

Keywords

Foot ulcers; Foot Surgery; Hyperspectral imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the investigator scheduled for foot surgery.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• KCI USA, Inc: collaborator

Study Sites (2)

Parkland Health and Hospital System

Dallas, Texas, 75390, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Foot Ulcer; Osteomyelitis

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Lawrence A Lavery, DPM, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: December 26, 2018
• Study Start: June 13, 2014
• Primary Completion: June 13, 2014
• Study Completion: June 13, 2015
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

US (2)