Imaging Evaluation, Peripheral Arterial Disease(PAD)
Conditions
Keywords
Spatial Frequency Domain Imaging, Peripheral Arterial Disease, Non-invasive imaging
Brief summary
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.
Interventions
OTHERSFDI
SFDI imaging is performed on both treated and untreated limb.
Sponsors
Singapore General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Spatial Frequency Domain Imaging (SFDI) Imaging pre and post-ll angioplasty
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in perfusion measured by tissue oxygen saturation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare SFDI measurements to Toe Pressure | Pre and Post angioplasty on Day 0 | Toe Pressure measurements are done pre and post-op and compared against SFDI values obtained. |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORTze Tec Chong
Singapore General Hospital
Outcome results
None listed