Peripheral Arterial DiseaseNCT06237621
Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment
An observational study of Peripheral Arterial Disease, run by Kent Imaging Inc at 1 site in United States.
Trial summary
The objective of this trial is to determine if Near-infrared spectroscopy (NIRS) can accurately evaluate the degree of Peripheral Arterial Disease (PAD) during a Provocative Elevation Maneuver of the Lower Extremity (PEMLE) test, as compared to routine clinical assessments. Read more about this study
- Who is it for?
- Ages 35 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- SnapshotNIR imaging
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be enrolled through the PI's clinic population. Healthy volunteers will be recruited from the clinic staff population and other volunteers recruited from healthy clinic visitors. Subjects who are identified for study participation will be screened for all eligibility requirements. Those meeting eligibility criteria for the study will have the study explained to them by the study staff. An Informed Consent Form will be provided to sign, prior to undergoing any study procedures. Subjects will be encouraged to ask questions of the study staff. There is no cap on the number of subjects that can be screened. Additional subjects will continue to be recruited as needed to reach the total study enrollment of 250 limbs.
Who may be able to join
- 35-99 years of age
- Subject has at least 1 intact forefoot
- Can achieve leg positions to complete the study
Who cannot join
- The subject is unwilling or unable to comply with the protocol or scheduled appointments.
- The subject has had transmetatarsal amputation or higher on both limbs.
- Vascular intervention within the past year
- Subjects who have had a previous distal bypass procedure
- Pregnant or plans to become pregnant
- Deemed by the PI to be unsuitable for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Henrik Claeson, 210-567-8279, claeson@uthscsa.edu
About this study
Official title: Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.
The objective of this trial is to determine if Near-infrared spectroscopy (NIRS) can accurately evaluate the degree of Peripheral Arterial Disease (PAD) during a Provocative Elevation Maneuver of the Lower Extremity (PEMLE) test, as compared to routine clinical assessments.
Read the detailed description
This study is designed as a prospective observational study to assess the effectiveness of NIRS to accurately evaluate the degree of PAD, as compared to routine clinical assessment, during the PEMLE test protocol. This will be a single visit study where subjects will be screened and enrolled during a regular clinic visit.
- Conditions
- Peripheral Arterial Disease
- Being tested
- SnapshotNIR imaging
- Keywords
- Ankle-brachial index, Tissue Oxygen Saturation, Near infrared spectroscopy, NIR, Peripheral Arterial Disease, PAD, CLI, Provocative Leg Maneuver, PAD screening
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SnapshotNIR imagingDevice
SnapshotNIR will be used for tissue oxygen-saturation imaging of all the subjects' foot along with standard of care procedures for PAD assessment.
| Study group | Role | What they receive |
|---|---|---|
| People at risk of PAD | Not described Receives: Device: SnapshotNIR imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD
The significance of the relationship will be evaluated using an analysis of variance (ANOVA) where the independent variable will be the SOC assessment of PAD and the dependent variable will be the difference in NIRS measurement between the initial position (supine) and the second position (elevated leg).
Measured: 1-2 days
Secondary outcomes (3)
Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test paired with the presence/absence of diabetes to the SOC clinical assessment of PAD
This outcome will be evaluated using an analysis of variance (ANOVA) with two independent variables (factors) including the SOC assessment of PAD and the presence of diabetes (present or not) and the dependent variable will be the difference in NIRS measurement between the initial position (supine) and the second position (elevated leg).
Measured: 1-2 days
Comparing change in dorsal foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD
This outcome will be evaluated in a similar fashion as the analysis from the primary outcome but with the dependent variable will be calculated based on measurements taken from the dorsal surface of the foot which will be evaluated against the independent variable (SOC assessment) via ANOVA.
Measured: 1-2 days
Change of NIRS measurements with other positions
This outcome will be evaluated in a similar fashion as the analysis from the primary outcome but with the dependent variable being the difference in NIRS measurement between the raised and dependent position (patient sitting up) and then the baseline and dependent position which will be evaluated against the independent variable (SOC assessment) via ANOVA.
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start12 Feb 2024
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kent Imaging Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237621
- Sponsor's protocol ID
- 20230638HU
- Status last verified
- Oct 2024
- First submitted
- 10 Jan 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.
- ClinicalTrials.gov ID
- NCT06237621
- Acronym / sponsor ID
- 20230638HU
- Conditions
- Peripheral Arterial Disease
- Keywords
- Ankle-brachial index, Tissue Oxygen Saturation, Near infrared spectroscopy, NIR, Peripheral Arterial Disease, PAD, CLI, Provocative Leg Maneuver
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kent Imaging IncIndustry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 1 Feb 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.
The objective of this trial is to determine if Near-infrared spectroscopy (NIRS) can accurately evaluate the degree of Peripheral Arterial Disease (PAD) during a Provocative Elevation Maneuver of the Lower Extremity (PEMLE) test, as compared to routine clinical assessments.
Detailed description
This study is designed as a prospective observational study to assess the effectiveness of NIRS to accurately evaluate the degree of PAD, as compared to routine clinical assessment, during the PEMLE test protocol. This will be a single visit study where subjects will be screened and enrolled during a regular clinic visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People at risk of PAD | – | Device: SnapshotNIR imaging |
Who may qualify
- Ages
- 35 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled through the PI's clinic population. Healthy volunteers will be recruited from the clinic staff population and other volunteers recruited from healthy clinic visitors. Subjects who are identified for study participation will be screened for all eligibility requirements. Those meeting eligibility criteria for the study will have the study explained to them by the study staff. An Informed Consent Form will be provided to sign, prior to undergoing any study procedures. Subjects will be encouraged to ask questions of the study staff. There is no cap on the number of subjects that can be screened. Additional subjects will continue to be recruited as needed to reach the total study enrollment of 250 limbs.
Key inclusion criteria (3 listed)
- 35-99 years of age
- Subject has at least 1 intact forefoot
- Can achieve leg positions to complete the study
Key exclusion criteria (6 listed)
- The subject is unwilling or unable to comply with the protocol or scheduled appointments.
- The subject has had transmetatarsal amputation or higher on both limbs.
- Vascular intervention within the past year
- Subjects who have had a previous distal bypass procedure
- Pregnant or plans to become pregnant
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 |
|---|---|---|
| SnapshotNIR imagingSnapshotNIR will be used for tissue oxygen-saturation imaging of all the subjects' foot along with standard of care procedures for PAD assessment. | Device | People at risk of PAD |
Primary outcome
Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD
Time frame: 1-2 days
The significance of the relationship will be evaluated using an analysis of variance (ANOVA) where the independent variable will be the SOC assessment of PAD and the dependent variable will be the difference in NIRS measurement between the initial position (supine) and the second position (elevated leg).
3 secondary outcomes
Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test paired with the presence/absence of diabetes to the SOC clinical assessment of PAD
Time frame: 1-2 days
Comparing change in dorsal foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD
Time frame: 1-2 days
Change of NIRS measurements with other positions
Time frame: 1-2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Kent Imaging Inc at 1 site 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunny Sajjad, DPM ((210) 567-5131, sajjad@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD (time frame: 1-2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2024.