NIRS Imaging for Ulcers

No longer recruiting at 2 trial locations

Overseen By Najratun N Pinky, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kent Imaging Inc

Disqualifiers: Multiple research sites

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

Who Is on the Research Team?

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?

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

The control group will receive the standard of care per the facility Standard Operating Procedures (SOP)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A new Bayesian approach using lasso-based regularizations has been developed to improve the accuracy of reconstructing brain activity images from functional near-infrared spectroscopy (fNIRS) data, addressing challenges in the optical inverse model.

This method has been validated through simulations and experimental datasets, showing accurate image reconstruction with a low false-positive rate during motor and sensory tasks, indicating its potential for reliable brain activity monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain space image reconstruction of functional near-infrared spectroscopy using a Bayesian adaptive fused sparse overlapping group lasso model. Zhai, X., Santosa, H., Krafty, RT., et al.[2023]

A feasibility study involving 60 patients (40 females and 20 males, aged 46 to 91) demonstrated that multi-spectral and hyper-spectral imaging techniques can effectively evaluate chronic leg ulcers, focusing on tissue oxygenation.

The study revealed significant variability in oxygenation levels within the ulcers and surrounding tissue, highlighting the potential of these non-invasive methods for objective assessment and improved treatment strategies for chronic wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ANALYSIS OF TISSUE OXYGENATION IN CHRONIC LEG ULCERS BY COMBINATION OF A MULTI-SPECTRAL CAMERA AND A HYPER-SPECTRAL PROBE. Zimmermann, P., Scheibe, A., Marotz, J., et al.[2018]

Optical topography (OT) using near infrared spectroscopy (NIRS) offers a noninvasive way to map brain activity, providing advantages over traditional fMRI, such as easier measurement of hemodynamic responses and the ability to differentiate between oxy- and deoxy-hemoglobin.

The new software tool, functional optical signal analysis (fOSA), enhances the analysis of NIRS data by integrating it with statistical parametric mapping (SPM), allowing for detailed statistical inference about brain activity distribution across different conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional optical signal analysis: a software tool for near-infrared spectroscopy data processing incorporating statistical parametric mapping. Koh, PH., Glaser, DE., Flandin, G., et al.[2019]

In a pilot study involving 16 chronic diabetic foot ulcers, diffuse near infrared spectroscopy (NIRS) effectively predicted wound healing by measuring subsurface oxyhemoglobin concentration, showing that healed wounds had a consistent reduction in hemoglobin levels prior to closure.

Wounds that did not heal or resulted in amputations maintained elevated hemoglobin concentrations, indicating that NIRS could provide a more comprehensive assessment of wound healing compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near infrared wound monitor helps clinical assessment of diabetic foot ulcers. Neidrauer, M., Zubkov, L., Weingarten, MS., et al.[2022]

Diffuse near-infrared spectroscopy (DNIRS) can accurately predict healing in diabetic foot ulcers within just 4 weeks, achieving an 82% positive predictive value, which is significantly higher than traditional wound size measurements.

By using DNIRS to monitor healing trends, clinicians could potentially discontinue ineffective treatments earlier, saving over $12,600 per patient, thus improving both patient outcomes and healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffuse near-infrared spectroscopy prediction of healing in diabetic foot ulcers: a human study and cost analysis. Weingarten, MS., Samuels, JA., Neidrauer, M., et al.[2012]

A new dynamic tissue phantom has been developed for optical topography (OT) systems, allowing for controlled and realistic simulation of changes in tissue properties, which is crucial for testing and calibrating these systems.

This phantom uses a modified liquid crystal display (LCD) to create localized and dynamic changes in attenuation, effectively mimicking the cerebral haemodynamic response during functional activation, enhancing the accuracy of OT measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a dynamic test phantom for optical topography. Koh, PH., Elwell, CE., Delpy, DT.[2016]

Near infrared spectroscopy (NIRS) is a promising clinical tool that uses light to assess tissue oxygen levels, which can help predict the viability of skin flaps and the potential for wound healing.

The article presents several case studies demonstrating how NIRS can monitor the progress of wound closure after applying biologic wound products, highlighting its practical applications in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near-Infrared Spectroscopy Imaging for Assessing Skin and Wound Oxygen Perfusion. Landsman, AS., Barnhart, D., Sowa, M.[2019]

A study involving 23 patients with chronic leg ulcers demonstrated that non-invasive optical remittance spectroscopy can provide additional insights into wound assessment compared to traditional scoring methods.

The study found that while the correlation between spectroscopic readings and clinical wound scores was moderate (maximum correlation coefficients around +/- 0.5), the technique showed promise with a 69% accuracy in predicting wound scores, suggesting it could be a useful tool for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact-free spectroscopy of leg ulcers: principle, technique, and calculation of spectroscopic wound scores. Schmidt, WD., Liebold, K., Fassler, D., et al.[2019]

Citations

1.

withpower.com

withpower.com/trial/phase-ulcer-6-2024-5fa08

NIRS Imaging for Ulcers · Info for Participants

Research 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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12448248/

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.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06702852

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 ...

4.

researchgate.net

researchgate.net/publication/321141539_Assessing_the_Healing_of_Venous_Leg_Ulcers_Using_a_Noncontact_Near-Infrared_Optical_Imaging_Approach

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 ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/iwj.70109

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.gov

pubmed.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.

7.

kentimaging.com

kentimaging.com/blo2g-articles/clinical-applications-of-near-infrared-spectroscopy-in-wound-care-roundtable-report

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 ...

8.

mdpi.com

mdpi.com/2072-666X/10/3/180

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.