Assessment of Revascularization in Plantar Foot of Diabetic Patients Pre and Post Angioplasty Using Spatial Frequency Domain Imaging

NCT ID: NCT07097857

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-02
• Study Completion Date: 2025-12-31

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 ((Matheus et al., 2013)). 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 (Diabetes in Singapore: Stats and Prevention Tips - HealthXchange, n.d.). 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 ((Amputation of Limbs Regarded as a Last Resort - Singapore General Hospital, n.d.)).

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 ((SINGAPORE: ONE OF WORLD'S HIGHEST FOR DIABETES-RELATED LEG AMPUTATIONS, n.d.)). Unfortunately, the clinical success of these procedures in diabetics drop to 69% at 12 months (Lazaris et al., 2004). 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 (Lee et al., 2020). 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.

Conditions

Peripheral Arterial Disease(PAD); Imaging Evaluation

Keywords

Spatial Frequency Domain Imaging; Peripheral Arterial Disease; Non-invasive imaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SFDI Imaging

SFDI Imaging performed on both ipsilateral and contralateral foot. Imaging repeated on heel and pad regions of foot.

Group Type: EXPERIMENTAL

SFDI

Intervention Type: OTHER

SFDI imaging is performed on both treated and untreated limb.

Interventions

SFDI

SFDI imaging is performed on both treated and untreated limb.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tze Tec Chong

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

Singapore General Hospital

Singapore, SG, Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Charyl Yap, B.Sc

Role: CONTACT

Phone: +65 6576 7986

Email: charyl.yap.j.q@sgh.com.sg

Facility Contacts

Charyl Yap, B.Sc

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 32522482 (View on PubMed)

Amputation 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

Reference Type: BACKGROUND

Other Identifiers

2021/2648

Identifier Type: -

Identifier Source: org_study_id