Plantar foot revascularization imaging with Spatial Frequency Domain Imaging (SFDI) in diabetes
Assessment of Revascularization in Plantar Foot of Diabetic Mellitus Patients Pre and Post Angioplasty Using Spatial Frequency Domain Imaging
We will test whether non-invasive SFDI can show changes in blood flow and oxygen levels in the plantar foot before and after angioplasty in people with diabetes and peripheral arterial disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | Singapore General Hospital Academic / other |
| Locations | 1 site (Singapore, SG) |
| Trial ID | NCT07097857 on ClinicalTrials.gov |
What this trial studies
This interventional project uses Spatial Frequency Domain Imaging (SFDI) to capture non-invasive maps of tissue oxygenation, hemoglobin content, and perfusion in the plantar foot immediately before and after lower limb arterial angioplasty. Adult patients with diabetes undergoing angioplasty at Singapore General Hospital will undergo SFDI imaging along with standard clinical care. The study compares pre- and post-procedure SFDI metrics to identify immediate physiological changes associated with revascularization. Results will inform whether SFDI signals correlate with procedural success and could support larger studies linking imaging to limb-salvage outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults (21 years and older) with diabetes who are scheduled for lower limb arterial angioplasty and can provide informed consent and undergo non-invasive foot imaging.
Not a fit: Patients who are under 21, pregnant or breastfeeding, unable to give informed consent, incarcerated, or whose clinical condition (for example severe infection or extensive tissue loss) prevents reliable imaging are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, SFDI could give clinicians a quick, non-invasive way to confirm improved foot perfusion after angioplasty and help guide decisions about limb salvage.
How similar studies have performed: Prior small clinical and preclinical studies have shown SFDI can map tissue oxygenation and hemoglobin, but its use specifically to track peri-angioplasty revascularization is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Singapore, SG
- Singapore General Hospital — Singapore, Sg, Singapore (Recruiting)
Study contacts
- Principal investigator: Tze Tec Chong — Singapore General Hospital
- Study coordinator: Charyl Yap, B.Sc
- Email: charyl.yap.j.q@sgh.com.sg
- Phone: +65 6576 7986
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.