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

NCT04223089 | Completed FDA Device

• 1 other identifier: STUDY00144156
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Revascularization

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.

Diagnostic Test: Near Infrared Spectroscopy

Medical Management

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

Diagnostic Test: Near Infrared Spectroscopy

Interventions

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.

Medical Management; Revascularization

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective study will include up to 200 adult patients who present with non-healing lower extremity wounds to the University of Kansas Medical Center. Patients will be grouped into two study arms depending on the degree of tissue ischemia (above or below 40 mmHg) and required treatment (conservative wound care alone or revascularization). Relevant clinical information will be obtained from patients' medical records including demographics, clinical history, intervention details, surgical records, and imaging data. Wound healing will be assessed at presentation, at the time of revascularization (pre and post-operative), and every 6 weeks thereafter by clinical assessment, Wagner classification, TCOM PO2 measurements and NIRS PO2 measurements. TCOM will guide treatment decisions and management, which is the current standard of care.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Missouri, 66160, United States

Location

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Adam Alli, MD

  KUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: December 17, 2019
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)