Clinical trial NCT06702852: Effect of NIRS-assisted Assessment on Chronic Lower Extremity and Other Chronic Non-healing Ulcers
Official title: Investigation of the Predictive Value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic Non-healing Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ulcers
Keywords: tissue oxygenation
Near infrared spectroscopy
lower extremity ulcers
ulcers
SnapshotNIR
NIRS
imaging
oxyhemoglobin
deoxyhemoglobin
hemoglobin
oxygen saturation
wound healing
Lead sponsor: Kent Imaging Inc
Sponsor class: INDUSTRY
Collaborators: name: WoundCentrics LLC
First posted: 2024-11-25
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient health outcome
timeFrame: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
Secondary outcomes:
measure: Health Economic Impact
timeFrame: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
Other outcomes:
Locations:
city: New Braunfels
country: United States
facility: Christus Santa Rosa Wound Care and Hyperbaric Center
state: Texas
city: San Antonio
country: United States
facility: Christus Santa Rosa Wound Care and Hyperbaric Center
state: Texas
city: San Antonio
country: United States
facility: Christus Santa Rosa Wound Care and Hyperbaric Center
state: Texas
city: San Marcos
country: United States
facility: Christus Santa Rosa Wound Care and Hyperbaric Center
state: Texas
Study officials:
affiliation: CHRISTUS Santa Rosa Hospital Wound Care and Hyperbaric Center - San Antonio, Westover Hills, San Marcos and New Braunfels
name: Marcus L Gitterle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serena TE, Yaakov R, Serena L, Mayhugh T, Harrell K. Comparing near infrared spectroscopy and transcutaneous oxygen measurement in hard-to-heal wounds: a pilot study. J Wound Care. 2020 Jun 1;29(Sup6):S4-S9. doi: 10.12968/jowc.2020.29.Sup6.S4.
citation: Geskin G, Mulock MD, Tomko NL, Dasta A, Gopalakrishnan S. Effects of Lower Limb Revascularization on the Microcirculation of the Foot: A Retrospective Cohort Study. Diagnostics (Basel). 2022 May 26;12(6):1320. doi: 10.3390/diagnostics12061320.
citation: Farber A. Chronic Limb-Threatening Ischemia. N Engl J Med. 2018 Jul 12;379(2):171-180. doi: 10.1056/NEJMcp1709326. No abstract available.
citation: NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet. 2016 Apr 9;387(10027):1513-1530. doi: 10.1016/S0140-6736(16)00618-8. Epub 2016 Apr 6.