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

NCT06702852 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2025-05-23

No results posted yet for this study

Summary

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

Conditions

  • Ulcers

Interventions

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

Sponsors & Collaborators

  • WoundCentrics LLC

    collaborator UNKNOWN

  • Kent Imaging Inc

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2025-01-31
Completion
2025-02-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06702852 on ClinicalTrials.gov