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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-22

Study Completion Date

2025-02-25

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

The control group will receive the standard of care per the facility Standard Operating Procedures (SOP)

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

NIRS imaging in addition to SOC

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.