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 :
Active, not recruiting
First Posted : January 10, 2020
Last Update Posted : May 23, 2022
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Condition or disease | Intervention/treatment |
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Wound Heal | Diagnostic Test: Near Infrared Spectroscopy |
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, 2022 |
Estimated Study Completion Date : | October 31, 2022 |

Group/Cohort | Intervention/treatment |
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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.
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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:
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
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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:
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. |
- 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.

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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 |
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)

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
United States, Missouri | |
University of Kansas Medical Center | |
Kansas City, Missouri, United States, 66160 |
Principal Investigator: | Adam Alli, MD | KUMC |
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: | May 23, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Wounds and Injuries |