UlcersNCT06702852
Effect of NIRS-assisted Assessment on Chronic Lower Extremity and Other Chronic Non-healing Ulcers
A study testing NIRS imaging in addition to SOC in people with Ulcers, run by Kent Imaging Inc at 4 sites in United States.
Trial summary
Investigation of the predictive value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic non-healing Ulcers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcers
- What is being tested?
- NIRS imaging in addition to SOC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Jul 2024to 25 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are being treated at multiple research sites simultaneously.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Christus Santa Rosa Wound Care and Hyperbaric Center
New Braunfels, Texas, 78130
Christus Santa Rosa Wound Care and Hyperbaric Center
San Antonio, Texas, 78229
Christus Santa Rosa Wound Care and Hyperbaric Center
San Antonio, Texas, 78251
Christus Santa Rosa Wound Care and Hyperbaric Center
San Marcos, Texas, 78666
About this study
Official title: Investigation of the Predictive Value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic Non-healing Ulcers
Investigation of the predictive value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic non-healing Ulcers
Read the 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.
- Conditions
- Ulcers
- Being tested
- NIRS imaging in addition to SOC
- Keywords
- tissue oxygenation, Near infrared spectroscopy, lower extremity ulcers, ulcers, SnapshotNIR, NIRS, imaging, oxyhemoglobin, deoxyhemoglobin, hemoglobin, oxygen saturation, wound healing
- Medical subject headings
- Ulcer, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS imaging in addition to SOCDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will receive the standard of care per the facility Standard Operating Procedures (SOP) |
| Intervention | Experimental | 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 Receives: Device: NIRS imaging in addition to SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient health outcome
To evaluate the impact of the addition of NIRS to the SOP on patient health outcome by comparing between the control and interventional groups
Measured: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
Secondary outcomes (1)
Health Economic Impact
To evaluate the impact of the addition of NIRS to the SOP on treatment plans, interventions, and financial expenses by comparing between the control and interventional groups
Measured: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start22 Jul 2024
- Primary completion31 Jan 2025
- Study completion25 Feb 2025
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent Imaging Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WoundCentrics LLC
- Responsible party
- Sponsor
- Investigators
- Marcus L Gitterle, MD, Principal investigator, CHRISTUS Santa Rosa Hospital Wound Care and Hyperbaric Center - San Antonio, Westover Hills, San Marcos and New Braunfels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702852
- Sponsor's protocol ID
- MG-NIRS-03
- Status last verified
- May 2025
- First submitted
- 3 Oct 2024
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32530756Geskin 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.
PubMed 35741130Farber A. Chronic Limb-Threatening Ischemia. N Engl J Med. 2018 Jul 12;379(2):171-180. doi: 10.1056/NEJMcp1709326. No abstract available.
PubMed 29996085NCD 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.
PubMed 27061677
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Predictive Value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic Non-healing Ulcers
- ClinicalTrials.gov ID
- NCT06702852
- Acronym / sponsor ID
- MG-NIRS-03
- Conditions
- Ulcers
- Keywords
- tissue oxygenation, Near infrared spectroscopy, lower extremity ulcers, ulcers, SnapshotNIR, NIRS, imaging, oxyhemoglobin
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Kent Imaging IncIndustry (pharma, biotech, devices)
- Collaborators
- WoundCentrics LLC
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will receive the standard of care per the facility Standard Operating Procedures (SOP) |
| Intervention | Experimental | Device: NIRS imaging in addition to SOCThe intervention group will receive the standard of care per the facility Standard Operating Procedures (SOP) with the addition of NIRS imaging utilizing the SnapshotNIR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who are being treated at multiple research sites simultaneously.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS imaging in addition to SOCThe intervention group will receive the standard of care per the facility Standard Operating Procedures (SOP) with the addition of NIRS imaging utilizing the SnapshotNIR | Device | Intervention |
Primary outcome
Patient health outcome
Time frame: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
To evaluate the impact of the addition of NIRS to the SOP on patient health outcome by comparing between the control and interventional groups
1 secondary outcome
Health Economic Impact
Time frame: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 32530756Serena 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.
- Background: PubMed 35741130Geskin 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.
- Background: PubMed 29996085Farber A. Chronic Limb-Threatening Ischemia. N Engl J Med. 2018 Jul 12;379(2):171-180. doi: 10.1056/NEJMcp1709326. No abstract available.
- Background: PubMed 27061677NCD 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus L Gitterle, MD principal investigator
CHRISTUS Santa Rosa Hospital Wound Care and Hyperbaric Center - San Antonio, Westover Hills, San Marcos and New Braunfels
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS imaging in addition to SOC in people with Ulcers, run by Kent Imaging Inc at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient health outcome (time frame: From enrollment to closeout or 12 weeks from enrollment whichever is earlier). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06702852, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.