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

Completed

• Conditions: Wound Heal
• Interventions: Diagnostic Test: Near Infrared Spectroscopy

• Registration Number: NCT04223089
• Lead Sponsor: University of Kansas Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-17
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medical Management	Near Infrared Spectroscopy	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
Revascularization	Near Infrared Spectroscopy	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of NIRS measurements	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Missouri, United States