NIRS Imaging for Ulcers

No longer recruiting at 2 trial locations
TI
NN
Overseen ByNajratun N Pinky, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kent Imaging Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Near Infrared Spectroscopy (NIRS) can predict the healing of chronic ulcers (long-lasting open sores) on the lower legs and other areas. Participants will receive either standard care or standard care plus NIRS imaging, which uses special light to examine the ulcers. Individuals with long-lasting leg ulcers or other non-healing sores receiving treatment at Christus Wound Care and Hyperbaric Medicine Departments are suitable candidates for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future ulcer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that NIRS imaging is safe for use in chronic ulcer assessment?

Research has shown that NIRS imaging can predict ulcer healing by assessing blood oxygen levels. This non-invasive technology does not involve entering the body, often making it safer. Studies indicate that patients generally tolerate NIRS imaging well. No major reports of negative effects have emerged from its use, suggesting that NIRS imaging is generally safe for patients with ulcers.12345

Why are researchers excited about this trial?

Researchers are excited about using NIRS imaging for ulcers because it offers a non-invasive way to assess tissue health, potentially allowing for earlier and more accurate detection of problem areas. Unlike standard care options, which often rely on visual inspection and subjective assessment, NIRS (Near-Infrared Spectroscopy) provides objective data by measuring oxygen levels in the tissue. This innovative approach could lead to more personalized treatment plans and better outcomes for patients, as it helps clinicians target the most at-risk areas with precision.

What evidence suggests that NIRS imaging is effective for chronic ulcers?

Research has shown that NIRS imaging, which participants in this trial may receive, can predict the healing of venous leg ulcers and diabetic foot ulcers by monitoring changes in blood oxygen levels. This non-invasive imaging technique does not involve any cutting or surgery. It measures tissue oxygen levels to assess the wound's healing potential. Studies have demonstrated that NIRS imaging provides reliable information on wound healing. Overall, NIRS imaging aids doctors in understanding and predicting the healing process of chronic ulcers.12678

Who Is on the Research Team?

ML

Marcus L Gitterle, MD

Principal Investigator

CHRISTUS Santa Rosa Hospital Wound Care and Hyperbaric Center - San Antonio, Westover Hills, San Marcos and New Braunfels

Are You a Good Fit for This Trial?

This trial is for current or incoming patients at Christus Wound Care and Hyperbaric Medicine Departments with lower extremity ulcers or other chronic non-healing ulcers. It's open to those treated between July and December 2024, regardless of the cause of their wounds.

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
I have chronic ulcers on my lower extremity, regardless of their cause.

Exclusion Criteria

Patients who are being treated at multiple research sites simultaneously

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard care with or without NIRS imaging for chronic ulcers

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NIRS imaging
Trial Overview The study tests if Near Infrared Spectroscopy (NIRS) can predict healing in chronic ulcers when used alongside standard care. NIRS imaging might help doctors understand how well an ulcer is healing.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kent Imaging Inc

Lead Sponsor

Trials
2
Recruited
350+

WoundCentrics LLC

Collaborator

Trials
1
Recruited
200+

Published Research Related to This Trial

Noninvasive optical technologies are being developed to enhance wound assessment by providing detailed information about skin characteristics that are not visible to the naked eye, such as blood flow and inflammation.
These technologies, including near infrared imaging and optical coherence tomography, show promise in improving the evaluation of wound severity and healing potential, but they still require further validation to confirm their effectiveness.
Noninvasive imaging technologies for cutaneous wound assessment: A review.Paul, DW., Ghassemi, P., Ramella-Roman, JC., et al.[2023]
The proposed automatic ulcer segmentation system, which utilizes both visual and near-infrared imaging, effectively measures the surface area of lower extremity ulcers and tracks their healing over time, aiding clinicians in selecting appropriate therapies.
In a study involving 18 ulcers from 17 elderly patients, the system demonstrated a maximum error rate of 33% for measuring red/granulation tissue, indicating its feasibility for clinical use despite some limitations in accurately defining ulcer boundaries for deeper black/necrotic tissue.
Lower extremity ulcer image segmentation of visual and near-infrared imagery.Bochko, V., Välisuo, P., Harju, T., et al.[2010]
The study involved 81 patients with hard-to-heal venous leg ulcers (VLU) and used near infrared spectroscopy (NIRS) to measure hemoglobin O2 saturation and wound dimensions, showing that NIRS can predict healing outcomes.
Adjunctive hyperbaric oxygen therapy (HBOT) significantly improved VLU healing compared to conventional treatment alone, particularly with a longer treatment schedule (once daily for 6 weeks), resulting in a higher complete healing rate (20% vs. 4.5% in HBOT twice daily for 3 weeks).
Potential markers of healing from near infrared spectroscopy imaging of venous leg ulcer. A randomized controlled clinical trial comparing conventional with hyperbaric oxygen treatment.Longobardi, P., Hartwig, V., Santarella, L., et al.[2021]

Citations

NIRS Imaging for Ulcers · Info for ParticipantsResearch shows that NIRS imaging can help predict the healing of venous leg ulcers and diabetic foot ulcers by measuring changes in blood oxygen levels and ...
Mathematical modeling and analysis for tissue curvature ...Near-infrared spectroscopy (NIRS) imaging modalities are used to provide noncontact measurements of tissue oxygenation in diabetic foot ulcers.
Effect of NIRS-assisted Assessment on Chronic Lower ...The objective of this study is to evaluate the clinical and economical effect of introduction of near-infrared spectroscopy (NIRS) in the diagnostic and ...
Assessing the Healing of Venous Leg Ulcers Using a ...The efficacy of using diffuse near infrared spectroscopy (NIRS) in predicting wound healing in diabetic foot ulcers was demonstrated by conducting a pilot ...
Non‐invasive techniques for wound assessment: A ...Near Infrared Spectroscopic Imaging (NIRSI) is a non-invasive optical imaging technique utilized to evaluate oxygen perfusion in skin and wounds ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/33370248/
Visualization of Wound Healing Progression With Near ...The aim of this retrospective study is to determine if near infrared spectroscopy (NIRS) can be used to evaluate wounds and adjacent soft tissues.
Clinical Applications of NIRS Imaging in Wound Care ...This roundtable report explores the clinical applications of NIRS imaging, from assessing tissue oxygenation to guiding debridement and ...
Development and Validation of a Smartphone-Based Near- ...A smartphone-based near-infrared (NIR) imaging device was developed to measure physiological changes in tissues across a wide area and without contact.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security