NIRS Imaging for Ulcers

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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment NIRS imaging for ulcers?

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 wound size over time. This method has been shown to have a high accuracy in predicting healing outcomes, making it a valuable tool for clinicians in monitoring and selecting effective treatments for ulcers. ^{1 2 3 4 5}

Is NIRS imaging safe for use in humans?

NIRS imaging, which includes techniques like Near Infrared Spectroscopy and Optical Topography, is generally considered safe for humans as it is non-invasive and uses light to assess tissue characteristics without causing harm. ^{4 6 7 8 9}

How does the NIRS imaging treatment for ulcers differ from other treatments?

NIRS imaging for ulcers is unique because it uses near-infrared light to assess tissue oxygen levels, helping predict wound healing and monitor progress, unlike traditional treatments that may not provide such detailed insights into tissue health. ^{1 5 9 10 11}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Lower extremity ulcer image segmentation of visual and near-infrared imagery. [2010]

2. United States 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Contact-free spectroscopy of leg ulcers: principle, technique, and calculation of spectroscopic wound scores. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Diffuse near-infrared spectroscopy prediction of healing in diabetic foot ulcers: a human study and cost analysis. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

Near infrared wound monitor helps clinical assessment of diabetic foot ulcers. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Noninvasive imaging technologies for cutaneous wound assessment: A review. [2023]

7. Georgia (Republic) 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. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Development of a dynamic test phantom for optical topography. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Near-Infrared Spectroscopy Imaging for Assessing Skin and Wound Oxygen Perfusion. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Functional optical signal analysis: a software tool for near-infrared spectroscopy data processing incorporating statistical parametric mapping. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Brain space image reconstruction of functional near-infrared spectroscopy using a Bayesian adaptive fused sparse overlapping group lasso model. [2023]