TerminatedNot Applicable

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

Stopped: The study was terminated due to significant protocol deviations in the execution of the study that compromised data integrity. These deviations were unrelated to the safety or performance of the investigational device.

United States221 participantsStarted 2024-07-22

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Patient health outcome

Timeframe: From enrollment to closeout or 12 weeks from enrollment whichever is earlier

Trial details

NCT IDNCT06702852

SponsorKent Imaging Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-31

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