Accuracy of TCOM vs NIRS in Predicting Wound Outcomes in Patients Treated With or Without Revascularization
May 9, 2023 updated by: University of Kansas Medical Center
Accuracy of Transcutaneous Oxygen Monitoring (TCOM) vs Near Infrared Spectroscopy (NIRS) in Predicting Wound Outcomes in Patients Treated With or Without Revascularization
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
76
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Kansas City, Missouri, United States, 66160
- University of Kansas Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
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.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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:
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
|
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:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From presentation to wound healing or amputation (approximately 6 months at most)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Adam Alli, MD, KUMC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 17, 2019
Primary Completion (Actual)
October 31, 2022
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
January 7, 2020
First Submitted That Met QC Criteria
January 7, 2020
First Posted (Actual)
January 10, 2020
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 9, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00144156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.