NCT04223089

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Heal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-17
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2020-01-10
• Last updated: 2023-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study