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Accuracy of TCOM vs NIRS in Predicting Wound Outcomes in Patients Treated With or Without Revascularization

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ClinicalTrials.gov Identifier: NCT04223089
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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Brief Summary:
The primary purpose of this project is to compare the accuracy of transcutaneous oxygen monitoring and near infrared spectroscopy in assessing cutaneous oxygen levels in chronic wounds of patients following revascularization procedures as well as those with conservatively managed chronic wounds. This study will also compare the efficiency and practicality of both methods in guiding treatment decisions and management of these wounds.

Condition or disease Intervention/treatment
Wound Heal Diagnostic Test: Near Infrared Spectroscopy

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy of Transcutaneous Oxygen Monitoring (TCOM) vs Near Infrared Spectroscopy (NIRS) in Predicting Wound Outcomes in Patients Treated With or Without Revascularization
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Revascularization
This group will include patients whose cutaneous oxygen partial pressure (PO2) around the wound of interest measures less than 40 mmHg and therefore require revascularization.
 Diagnostic Test: Near Infrared Spectroscopy

The Kent Camera is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of the following in superficial tissue:

  • oxygen saturation (StO2),
  • relative oxyhemoglobin level (HbO2), and
  • relative deoxyhemoglobin (Hb) level

The Kent Camera displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions. The Kent Camera is indicated for use to determine oxygenation levels in superficial tissues.
Medical Management
This group will include patients whose cutaneous PO2 around the wound of interest measures greater than 40 mmHg and will be managed conservatively in wound clinic
 Diagnostic Test: Near Infrared Spectroscopy

The Kent Camera is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of the following in superficial tissue:

  • oxygen saturation (StO2),
  • relative oxyhemoglobin level (HbO2), and
  • relative deoxyhemoglobin (Hb) level

The Kent Camera displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions. The Kent Camera is indicated for use to determine oxygenation levels in superficial tissues.


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of NIRS measurements [ Time Frame: From presentation to wound healing or amputation (approximately 6 months at most) ]
    To determine the accuracy of near infrared spectroscopy when compared to transcutaneous oxygen monitoring in assessing cutaneous oxygen levels and guiding treatment in patients with revascularized tissues or conservatively managed chronic wounds.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This prospective study will include up to 200 adult patients who present with non-healing lower extremity wounds to the University of Kansas Medical Center. Patients will be grouped into two study arms depending on the degree of tissue ischemia (above or below 40 mmHg) and required treatment (conservative wound care alone or revascularization). Relevant clinical information will be obtained from patients' medical records including demographics, clinical history, intervention details, surgical records, and imaging data. Wound healing will be assessed at presentation, at the time of revascularization (pre and post-operative), and every 6 weeks thereafter by clinical assessment, Wagner classification, TCOM PO2 measurements and NIRS PO2 measurements. TCOM will guide treatment decisions and management, which is the current standard of care.
Criteria

Inclusion Criteria:

  • Are between the ages of 18-85
  • Presented with a non-healing lower extremity wound and have a Wagner classification for wound healing of grade 1 or 2

Exclusion Criteria:

  • Wagner grade 3-5
  • Congestive heart failure (CHF) with a left ventrical ejection fraction (LVEF) < 30%
  • Have had a below the knee drug eluting stent placed (paclitaxel is chemo, can make wounds worse)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04223089


Contacts
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Contact: Carissa Walter, MPH 913-945-7450 cwalter2@kumc.edu
Contact: Peyton Ackerman, BA 913-945-7369 ext 5-7369 packerman@kumc.edu

Locations
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United States, Missouri
University of Kansas Medical Center Recruiting
Kansas City, Missouri, United States, 66160
Contact: Carissa Walter, MPH    913-945-7450 ext 5-7450    cwalter2@kumc.edu   
Contact: Peyton Ackerman, BA    913-945-7369 ext 5-7369    packerman@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Adam Alli, MD KUMC
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04223089    
Other Study ID Numbers: STUDY00144156
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Wounds and Injuries