Accuracy of TCOM vs 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.

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Key information

Conditions

Wound Heal

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Missouri, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Near infrared spectroscopy

Diagnostic Test

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

Accuracy of Transcutaneous Oxygen Monitoring (TCOM) vs Near Infrared Spectroscopy (NIRS) in Predicting Wound Outcomes in Patients Treated With or Without Revascularization

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Jan 10, 2020
Registry last updated: May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed