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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223089
• Other study ID #: STUDY00144156
• Status: Completed
• Start date: December 17, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: May 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of NIRS measurements	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)