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

University of Kansas

Status: Completed

Conditions: Wound Heal

Treatments: Diagnostic Test: Near Infrared Spectroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT04223089

STUDY00144156

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

76 participants in 2 patient groups

Revascularization

Description:

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.

Treatment:

Diagnostic Test: Near Infrared Spectroscopy

Medical Management

Description:

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

Treatment:

Diagnostic Test: Near Infrared Spectroscopy