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

NCT07097857 | Recruiting

• 1 other identifier: 2021/2648
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the usefulness of SFDI in the assessment of revascularization pre and post intervention

Conditions

Peripheral Arterial Disease(PAD); Imaging Evaluation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre and Post angioplasty on Day 0

Secondary Outcomes (1)

• Compare SFDI measurements to Toe Pressure

  Pre and Post angioplasty on Day 0

Study Arms (1)

SFDI Imaging

EXPERIMENTAL

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

Other: SFDI

Interventions

SFDI OTHER

SFDI imaging is performed on both treated and untreated limb.

SFDI Imaging

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, SG, 169856, Singapore

RECRUITING

Related Publications (2)

• 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.

  PMID: 32522482 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Tze Tec Chong

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charyl Yap, B.Sc

CONTACT

+65 6576 7986; charyl.yap.j.q@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Spatial Frequency Domain Imaging (SFDI) Imaging pre and post-ll angioplasty

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: October 2, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)