Effect of NIRS-assisted Assessment on Chronic Lower Extremity and Other Chronic Non-healing Ulcers

May 20, 2025 updated by: Kent Imaging Inc

Investigation of the Predictive Value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic Non-healing Ulcers

Investigation of the predictive value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic non-healing Ulcers

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to evaluate the clinical and economical effect of introduction of near-infrared spectroscopy (NIRS) in the diagnostic and treatment protocol of patients with lower extremity (LE) ulcers as well as other chronic non-healing ulcers, and to determine a positive and/or negative predictive value or range of values for NIRS correlating to patient progress and outcomes.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • New Braunfels, Texas, United States, 78130
        • Christus Santa Rosa Wound Care and Hyperbaric Center
      • San Antonio, Texas, United States, 78229
        • Christus Santa Rosa Wound Care and Hyperbaric Center
      • San Antonio, Texas, United States, 78251
        • Christus Santa Rosa Wound Care and Hyperbaric Center
      • San Marcos, Texas, United States, 78666
        • Christus Santa Rosa Wound Care and Hyperbaric Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Current patients or patients admitted to Christus Wound Care and Hyperbaric Medicine Departments between July 1, 2024, and December 31, 2024, for the treatment of lower extremity ulcers and other chronic non-healing ulcers.
  • Lower extremity ulcers and chronic non-healing ulcers will be included in the study regardless of the wound/ulcer etiology. Patients may become eligible for the study at any point during their course of treatment.

Exclusion Criteria:

  • Patients who are being treated at multiple research sites simultaneously.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The control group will receive the standard of care per the facility Standard Operating Procedures (SOP)
Experimental: Intervention
The intervention group will receive the standard of care per the facility Standard Operating Procedures (SOP) with the addition of NIRS imaging utilizing the SnapshotNIR
Device: NIRS imaging in addition to SOC
The intervention group will receive the standard of care per the facility Standard Operating Procedures (SOP) with the addition of NIRS imaging utilizing the SnapshotNIR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient health outcome
Time Frame: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
To evaluate the impact of the addition of NIRS to the SOP on patient health outcome by comparing between the control and interventional groups
From enrollment to closeout or 12 weeks from enrollment whichever is earlier

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Economic Impact
Time Frame: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
To evaluate the impact of the addition of NIRS to the SOP on treatment plans, interventions, and financial expenses by comparing between the control and interventional groups
From enrollment to closeout or 12 weeks from enrollment whichever is earlier

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kent Imaging Inc

Collaborators

WoundCentrics LLC

Investigators

  • Principal Investigator: Marcus L Gitterle, MD, CHRISTUS Santa Rosa Hospital Wound Care and Hyperbaric Center - San Antonio, Westover Hills, San Marcos and New Braunfels

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

February 25, 2025

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Actual)

November 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG-NIRS-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcers

Clinical Trials on NIRS imaging in addition to SOC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe