Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients

Amputation Clinical Trial

— HSI  

Official title:

Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03787862
• Other study ID #: HSI in Foot Surgery
• Status: Withdrawn
• Start date: June 13, 2014
• Est. completion date: June 13, 2015

Study information

• Verified date: December 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 13, 2015
• Est. primary completion date: June 13, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation
• Foot Ulcer
• Foot Ulcers
• Osteomyelitis

Locations

Country	Name	City	State
United States	Parkland Health and Hospital System	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	KCI USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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