Ulcer FootNCT03144050
Optical Imaging For Assessment of Foot Perfusion
An observational study of Ulcer Foot and Diabetes, run by Modulated Imaging Inc. at 1 site in United States.
Trial summary
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcer Foot, Diabetes
- What is being tested?
- SFDI Imaging
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2017to 31 Jul 2018
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any person at risk for foot ulcer formation
Who may be able to join
- -
Who cannot join
- Pregnant/lactating women
- Rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kaiser Permanente
Los Angeles, California, 90034
Kalvin Yu, MD
About this study
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic.
Read the detailed description
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic. SFDI is a non-contact optical imaging technology that measures tissue functional (blood volume, tissue oxygen saturation) and structural information (scattering index) across a large field of view. Our hypothesis is that SFDI parameters can eventually become a quantitative tool to assess foot health and identify patients at risk for ulcer formation. This phase of the study is designed to correlate SFDI outputs to current clinical risk categories
- Conditions
- Ulcer Foot, Diabetes
- Being tested
- SFDI Imaging
- Medical subject headings
- Foot Ulcer, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFDI ImagingDevice
Also called OxImager
Imaging with SFDI device
| Study group | Role | What they receive |
|---|---|---|
| 0 | Control - no diabetes Receives: Device: SFDI Imaging | |
| 1 | Diabetes Receives: Device: SFDI Imaging | |
| 2 | Diabetes w/neuropathy Receives: Device: SFDI Imaging | |
| 3 | Diabetes with vascular disease Receives: Device: SFDI Imaging | |
| 4 | Diabetes w/healed ulcer Receives: Device: SFDI Imaging | |
| 5 | Diabetes with current ulcer Receives: Device: SFDI Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical risk category
risk assessment based on clinical signs
Measured: immediate
Secondary outcomes (1)
Ulcer incidence
Ulcer formation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start14 Apr 2017
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcer FootStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Modulated Imaging Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144050
- Sponsor's protocol ID
- 11150
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Imaging For Assessment of Foot Perfusion
- ClinicalTrials.gov ID
- NCT03144050
- Acronym / sponsor ID
- 11150
- Conditions
- Ulcer Foot, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Modulated Imaging Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 8 May 2017 (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.
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic.
Detailed description
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic. SFDI is a non-contact optical imaging technology that measures tissue functional (blood volume, tissue oxygen saturation) and structural information (scattering index) across a large field of view. Our hypothesis is that SFDI parameters can eventually become a quantitative tool to assess foot health and identify patients at risk for ulcer formation. This phase of the study is designed to correlate SFDI outputs to current clinical risk categories
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0 | – | Device: SFDI ImagingControl - no diabetes |
| 1 | – | Device: SFDI ImagingDiabetes |
| 2 | – | Device: SFDI ImagingDiabetes w/neuropathy |
| 3 | – | Device: SFDI ImagingDiabetes with vascular disease |
| 4 | – | Device: SFDI ImagingDiabetes w/healed ulcer |
| 5 | – | Device: SFDI ImagingDiabetes with current ulcer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any person at risk for foot ulcer formation
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (2 listed)
- Pregnant/lactating women
- Rheumatoid arthritis
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 |
|---|---|---|
| SFDI ImagingAlso: OxImagerImaging with SFDI device | Device | 0, 1, 2, 3, 4, 5 |
Primary outcome
Clinical risk category
Time frame: immediate
risk assessment based on clinical signs
1 secondary outcome
Ulcer incidence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
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 Ulcer Foot and Diabetes, run by Modulated 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kalvin Yu, MD (6264053906, kalvin.c.yu@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical risk category (time frame: immediate). 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 8 May 2017.