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

Not Applicable

Recruiting

• Conditions: Ulcers

• Registration Number: NCT06702852
• Lead Sponsor: Kent Imaging Inc

Brief Summary

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

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 Timeline

• Study Start: 2024-07-22
• Study First Submitted: 2024-10-03
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-01-31
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient health outcome	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

Secondary Outcome Measures

Name	Time	Method
Health Economic Impact	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

Trial Locations

Locations (1)

Christus Santa Rosa Wound Care and Hyperbaric Center; 🇺🇸 San Marcos, Texas, United States