SFDI biomarkers provide a quantitative ulcer risk metric and can be used to predict diabetic foot ulcer onset.
Suzette Lee, Leann Mey, Agnieszka F Szymanska...
https://pubmed.ncbi.nlm.nih.gov/32522482Actively Recruiting
Phase Not Applicable
Age: 21Years - 99Years
All Genders
ID07097857
Assessment of Revascularization in Plantar Foot of Diabetic Mellitus Patients Pre and Post Angioplasty Using Spatial Frequency Domain Imaging
Led by Singapore General Hospital · Updated on 2025-07-31
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Diabetes is a widespread chronic condition that leads to high risks of cardiovascular problems and lower limb amputations. This research explores how Spatial Frequency Domain Imaging (SFDI), a noninvasive optical method, can assess blood flow changes before and after lower limb revascularization procedures like angioplasty in diabetic patients. The trial aims to determine if SFDI can provide objective feedback to predict outcomes and aid early intervention to save limbs. Participants will undergo SFDI imaging on both the treated and untreated feet, focusing on the heel and pad areas. Imaging is done before and after the angioplasty procedure on the same day to capture changes in tissue oxygen saturation and hemoglobin. This pilot study involves 15 diabetic patients having lower limb arterial angioplasty. During the study, participants will have noninvasive foot assessments using SFDI to monitor tissue oxygen levels and blood flow. Researchers will compare these imaging results with toe pressure measurements to evaluate changes in perfusion caused by angioplasty. The primary measure is the change in tissue oxygen saturation immediately before and after the procedure. The overall participation lasts around the intervention day with imaging assessments pre- and post-operation.
CONDITIONS
Brief Title
Assessment of Revascularization in Plantar Foot of Diabetic Patients Pre and Post Angioplasty Using Spatial Frequency Domain Imaging
Who Can Participate
Age: 21Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 21 years and above with diabetes undergoing lower limb arterial angioplasty
- Willingness to participate and undergo foot physiological assessments using SFDI
You will not qualify if you...
- Mentally incompetent individuals
- Patients younger than 21 years
- Prisoners
- Pregnant or breastfeeding women
- Patients unable to provide informed consent
- Any medical condition that makes participation inappropriate in the investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Day 0
Participants undergo Spatial Frequency Domain Imaging (SFDI) of the plantar foot before and after the angioplasty procedure to assess tissue oxygen saturation and perfusion.
1 visit on day of angioplasty (in-person)
Long-term Monitoring
Duration - Up to 12 months
Participants are observed to monitor outcomes related to limb perfusion and potential limb salvage post procedure.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
Singapore General Hospital
Singapore, SG, Singapore, 169856
Actively Recruiting
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Research Team
C
Charyl Yap, B.Sc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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