Diabetic Foot UlcerNCT03341559
Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing
An observational study of Diabetic Foot Ulcer, run by University of Southern California 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 for prediction of both healing and formation of diabetic foot ulcers. The investigators will perform longitudinal imaging (for 12 months) in two cohorts of subjects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Spatial Frequency Domain Imaging (SFDI)
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 13 Feb 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Male or female patients at University of Southern California diagnosed with a Diabetic Foot Ulcer
Who may be able to join
- Will be followed up in clinic on monthly basis for the next 12 months per standard of care II. Belong to one of the two target groups
- Subjects with an existing diabetic foot ulcer
- Subjects determined "at risk" for an ulcer
Who cannot join
- History of heart failure
- Rheumatoid arthritis
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck Medical Center of USC
Los Angeles, California, 90033
About this study
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers.
The investigators will perform longitudinal imaging (for 12 months) in two cohorts of subjects
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Spatial Frequency Domain Imaging (SFDI)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial Frequency Domain Imaging (SFDI)Device
Also called Reflect RS
Observational study to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers using Reflect RS
| Study group | Role | What they receive |
|---|---|---|
| With Existing Diabetic Ulcers | Current DFU Receives: Device: Spatial Frequency Domain Imaging (SFDI) | |
| Diabetic Ulcers in remission | DFU in remission Receives: Device: Spatial Frequency Domain Imaging (SFDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion in lower extremities
SFDI data outputs
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start20 Mar 2018
- Primary completion31 Dec 2019
- Study completion13 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Modulated Imaging Inc.
- Responsible party
- Principal investigator, David Armstrong, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341559
- Sponsor's protocol ID
- APP-17-06886
- Status last verified
- Mar 2020
- First submitted
- 6 Nov 2017
- Last updated
- 24 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Murphy GA, Singh-Moon RP, Mazhar A, Cuccia DJ, Rowe VL, Armstrong DG. Quantifying dermal microcirculatory changes of neuropathic and neuroischemic diabetic foot ulcers using spatial frequency domain imaging: a shade of things to come? BMJ Open Diabetes Res Care. 2020 Nov;8(2):e001815. doi: 10.1136/bmjdrc-2020-001815.
PubMed 33219118
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing
- ClinicalTrials.gov ID
- NCT03341559
- Acronym / sponsor ID
- APP-17-06886
- Conditions
- Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Modulated Imaging Inc.
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 14 Nov 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 for prediction of both healing and formation of diabetic foot ulcers.
The investigators will perform longitudinal imaging (for 12 months) in two cohorts of subjects
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Existing Diabetic Ulcers | – | Device: Spatial Frequency Domain Imaging (SFDI)Current DFU |
| Diabetic Ulcers in remission | – | Device: Spatial Frequency Domain Imaging (SFDI)DFU in remission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients at University of Southern California diagnosed with a Diabetic Foot Ulcer
Key inclusion criteria (3 listed)
- Will be followed up in clinic on monthly basis for the next 12 months per standard of care II. Belong to one of the two target groups
- Subjects with an existing diabetic foot ulcer
- Subjects determined "at risk" for an ulcer
Key exclusion criteria (3 listed)
- History of heart failure
- Rheumatoid arthritis
- Pregnant or lactating women
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 |
|---|---|---|
| Spatial Frequency Domain Imaging (SFDI)Also: Reflect RSObservational study to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers using Reflect RS | Device | Diabetic Ulcers in remission, With Existing Diabetic Ulcers |
Primary outcome
Perfusion in lower extremities
Time frame: 12-month
SFDI data outputs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 33219118Murphy GA, Singh-Moon RP, Mazhar A, Cuccia DJ, Rowe VL, Armstrong DG. Quantifying dermal microcirculatory changes of neuropathic and neuroischemic diabetic foot ulcers using spatial frequency domain imaging: a shade of things to come? BMJ Open Diabetes Res Care. 2020 Nov;8(2):e001815. doi: 10.1136/bmjdrc-2020-001815.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetic Foot Ulcer, run by University of Southern California 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 3 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: finished, as of the sponsor's last update on 24 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perfusion in lower extremities (time frame: 12-month). 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 NCT03341559, which also lists 1 linked publication.
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 24 Mar 2020.