Peripheral Arterial Disease(PAD)NCT07097857
Assessment of Revascularization in Plantar Foot of Diabetic Patients Pre and Post Angioplasty Using Spatial Frequency Domain Imaging
A study testing SFDI in people with Peripheral Arterial Disease(PAD) and Imaging Evaluation, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
To explore the usefulness of SFDI in the assessment of revascularization pre and post intervention Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Peripheral Arterial Disease(PAD), Imaging Evaluation
- What is being tested?
- SFDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Oct 2024to 31 Dec 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of age 21 years and above with diabetes and undergoing lower limb arterial angioplasty
- Willingness to participate in the study and undergo foot physiological assessments using SFDI
Who cannot join
- Mentally incompetent, younger than 21 years of age, prisoners, pregnant or breastfeeding women
- Patients unable to provide informed consent
- Any medical condition which makes the candidate an inappropriate subject for study participation, in the investigator's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Revascularization in Plantar Foot of Diabetic Mellitus Patients Pre and Post Angioplasty Using Spatial Frequency Domain Imaging
To explore the usefulness of SFDI in the assessment of revascularization pre and post intervention
Read the detailed description
Diabetes is a chronic disease with high cardiovascular morbidity and mortality. Approximately 150 million worldwide are suffering from this condition and the number is expected to rise to 300 million by 2025. In Singapore, diabetes is the 10th leading cause of death accounting for 1.7 per cent total deaths in 2011. By 2030, the number of Singapore residents above 40 with diabetes is projected to increase by another 200,000 from about 400,000 today. Despite having one of the world's highest life expectancies and a modern health care system, Singapore has one of the highest rates of lower extremity amputation (LEA) in the world, with public hospitals here needing to conduct some four amputation procedures a day
However, patients who seek treatment early enough have the option of various intervention treatments to salvage limbs. These include re-vascularisation (angioplasty or bypass) and treatment of infection (drainage of abscesses or debridement). In Singapore, limb salvage therapies have led to a 20% reduction in LEA operations in 2015 compared to the year before. Unfortunately, the clinical success of these procedures in diabetics drop to 69% at 12 months. This is owing to the lack of objective feedback of limb perfusion. Non invasive imaging modalities that predict outcomes of such revascularization procedures can help in early intervention and thus limb salvage. Recently, SFDI, a noninvasive optical imaging method capable of measuring tissue oxygen saturation (StO2) and tissue haemoglobin has been show to predict diabetic foot ulcer onset in the US population. Herein, we hypothesize that these microvasculature information offered by SFDI can be used to predict the outcomes of revascularization procedures. To test this hypothesis, we propose an exploratory pilot study to use SFDI on 15 diabetic patients undergoing lower limb revascularization and acquire images of the plantar foot before and after the intervention.
- Being tested
- SFDI
- Keywords
- Spatial Frequency Domain Imaging, Peripheral Arterial Disease, Non-invasive imaging
- 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.
SFDIOther
SFDI imaging is performed on both treated and untreated limb.
| Study group | Role | What they receive |
|---|---|---|
| SFDI Imaging | Experimental | SFDI Imaging performed on both ipsilateral and contralateral foot. Imaging repeated on heel and pad regions of foot. Receives: Other: SFDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perfusion measured by tissue oxygen saturation
Change in perfusion is assessed by level of tissue oxygen saturation measured pre and post revascularization to evaluate the usefulness of SFDI in the assessment of revascularization pre and post intervention.
Measured: Pre and Post angioplasty on Day 0
Secondary outcomes (1)
Compare SFDI measurements to Toe Pressure
Toe Pressure measurements are done pre and post-op and compared against SFDI values obtained.
Measured: Pre and Post angioplasty on Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start2 Oct 2024
- Primary completion8 Aug 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial Disease(PAD)Studies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Spatial Frequency Domain Imaging (SFDI) Imaging pre and post-ll angioplasty
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tze Tec Chong, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097857
- Sponsor's protocol ID
- 2021/2648
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data is protected by Personal Data Protection Act.
Publications
Lee S, Mey L, Szymanska AF, Takhar HS, Cuccia DJ, Mazhar A, Yu K. SFDI biomarkers provide a quantitative ulcer risk metric and can be used to predict diabetic foot ulcer onset. J Diabetes Complications. 2020 Sep;34(9):107624. doi: 10.1016/j.jdiacomp.2020.107624. Epub 2020 May 19.
PubMed 32522482Amputation of limbs regarded as a last resort - Singapore General Hospital. (n.d.). Retrieved June 29, 2021, from https://www.sgh.com.sg/news/patient-care/amputation-of-limbs-regarded-as-a-last-resort
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Revascularization in Plantar Foot of Diabetic Mellitus Patients Pre and Post Angioplasty Using Spatial Frequency Domain Imaging
- ClinicalTrials.gov ID
- NCT07097857
- Acronym / sponsor ID
- 2021/2648
- Keywords
- Spatial Frequency Domain Imaging, Peripheral Arterial Disease, Non-invasive imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 31 Jul 2025 (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.
To explore the usefulness of SFDI in the assessment of revascularization pre and post intervention
Detailed description
Diabetes is a chronic disease with high cardiovascular morbidity and mortality. Approximately 150 million worldwide are suffering from this condition and the number is expected to rise to 300 million by 2025. In Singapore, diabetes is the 10th leading cause of death accounting for 1.7 per cent total deaths in 2011. By 2030, the number of Singapore residents above 40 with diabetes is projected to increase by another 200,000 from about 400,000 today. Despite having one of the world's highest life expectancies and a modern health care system, Singapore has one of the highest rates of lower extremity amputation (LEA) in the world, with public hospitals here needing to conduct some four amputation procedures a day
However, patients who seek treatment early enough have the option of various intervention treatments to salvage limbs. These include re-vascularisation (angioplasty or bypass) and treatment of infection (drainage of abscesses or debridement). In Singapore, limb salvage therapies have led to a 20% reduction in LEA operations in 2015 compared to the year before. Unfortunately, the clinical success of these procedures in diabetics drop to 69% at 12 months. This is owing to the lack of objective feedback of limb perfusion. Non invasive imaging modalities that predict outcomes of such revascularization procedures can help in early intervention and thus limb salvage. Recently, SFDI, a noninvasive optical imaging method capable of measuring tissue oxygen saturation (StO2) and tissue haemoglobin has been show to predict diabetic foot ulcer onset in the US population. Herein, we hypothesize that these microvasculature information offered by SFDI can be used to predict the outcomes of revascularization procedures. To test this hypothesis, we propose an exploratory pilot study to use SFDI on 15 diabetic patients undergoing lower limb revascularization and acquire images of the plantar foot before and after the intervention.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Spatial Frequency Domain Imaging (SFDI) Imaging pre and post-ll angioplasty
| Arm | Type | Receives |
|---|---|---|
| SFDI Imaging | Experimental | Other: SFDISFDI Imaging performed on both ipsilateral and contralateral foot. Imaging repeated on heel and pad regions of foot. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of age 21 years and above with diabetes and undergoing lower limb arterial angioplasty
- Willingness to participate in the study and undergo foot physiological assessments using SFDI
Key exclusion criteria (3 listed)
- Mentally incompetent, younger than 21 years of age, prisoners, pregnant or breastfeeding women
- Patients unable to provide informed consent
- Any medical condition which makes the candidate an inappropriate subject for study participation, in the investigator's judgment
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 |
|---|---|---|
| SFDISFDI imaging is performed on both treated and untreated limb. | Other | SFDI Imaging |
Primary outcome
Change in perfusion measured by tissue oxygen saturation
Time frame: Pre and Post angioplasty on Day 0
Change in perfusion is assessed by level of tissue oxygen saturation measured pre and post revascularization to evaluate the usefulness of SFDI in the assessment of revascularization pre and post intervention.
1 secondary outcome
Compare SFDI measurements to Toe Pressure
Time frame: Pre and Post angioplasty on Day 0
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 18 Aug 2026.
- Background: PubMed 32522482Lee S, Mey L, Szymanska AF, Takhar HS, Cuccia DJ, Mazhar A, Yu K. SFDI biomarkers provide a quantitative ulcer risk metric and can be used to predict diabetic foot ulcer onset. J Diabetes Complications. 2020 Sep;34(9):107624. doi: 10.1016/j.jdiacomp.2020.107624. Epub 2020 May 19.
- BackgroundAmputation of limbs regarded as a last resort - Singapore General Hospital. (n.d.). Retrieved June 29, 2021, from https://www.sgh.com.sg/news/patient-care/amputation-of-limbs-regarded-as-a-last-resort
- Individual participant dataSharing planned: No. All data is protected by Personal Data Protection Act.
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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.
Tze Tec Chong principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SFDI in people with Peripheral Arterial Disease(PAD) and Imaging Evaluation, run by Singapore General Hospital at 1 site in Singapore.
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 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 18 Aug 2026. 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 Singapore. 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?
Change in perfusion measured by tissue oxygen saturation (time frame: Pre and Post angioplasty on Day 0). 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 NCT07097857, which also lists 2 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 18 Aug 2026.