Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing
1 other identifier
observational
23
1 country
1
Brief Summary
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers. The investigators will perform longitudinal imaging (for 12 months) in two cohorts of subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2017
CompletedFirst Posted
Study publicly available on registry
November 14, 2017
CompletedStudy Start
First participant enrolled
March 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2020
CompletedMarch 24, 2020
March 1, 2020
1.8 years
November 6, 2017
March 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Perfusion in lower extremities
SFDI data outputs
12-month
Study Arms (2)
With Existing Diabetic Ulcers
Current DFU
Diabetic Ulcers in remission
DFU in remission
Interventions
Observational study to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers using Reflect RS
Eligibility Criteria
Male or female patients at University of Southern California diagnosed with a Diabetic Foot Ulcer
You may qualify if:
- I. Will be followed up in clinic on monthly basis for the next 12 months per standard of care II. Belong to one of the two target groups
- Subjects with an existing diabetic foot ulcer
- Subjects determined "at risk" for an ulcer
You may not qualify if:
- History of heart failure
- Rheumatoid arthritis
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- Modulated Imaging Inc.collaborator
Study Sites (1)
Keck Medical Center of USC
Los Angeles, California, 90033, United States
Related Publications (1)
Murphy GA, Singh-Moon RP, Mazhar A, Cuccia DJ, Rowe VL, Armstrong DG. Quantifying dermal microcirculatory changes of neuropathic and neuroischemic diabetic foot ulcers using spatial frequency domain imaging: a shade of things to come? BMJ Open Diabetes Res Care. 2020 Nov;8(2):e001815. doi: 10.1136/bmjdrc-2020-001815.
PMID: 33219118DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery and Director, Southwestern Academic Limb Salvage Alliance (SALSA)
Study Record Dates
First Submitted
November 6, 2017
First Posted
November 14, 2017
Study Start
March 20, 2018
Primary Completion
December 31, 2019
Study Completion
February 13, 2020
Last Updated
March 24, 2020
Record last verified: 2020-03