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Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing

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ClinicalTrials.gov Identifier: NCT03341559
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Modulated Imaging Inc.
Information provided by (Responsible Party):
David Armstrong, University of Southern California

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


Condition or disease Intervention/treatment
Diabetic Foot Ulcer Device: Spatial Frequency Domain Imaging (SFDI)

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : February 13, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
With Existing Diabetic Ulcers
Current DFU
Device: Spatial Frequency Domain Imaging (SFDI)
Observational study to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers using Reflect RS
Other Name: Reflect RS

Diabetic Ulcers in remission
DFU in remission
Device: Spatial Frequency Domain Imaging (SFDI)
Observational study to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers using Reflect RS
Other Name: Reflect RS




Primary Outcome Measures :
  1. Perfusion in lower extremities [ Time Frame: 12-month ]
    SFDI data outputs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male or female patients at University of Southern California diagnosed with a Diabetic Foot Ulcer
Criteria

Inclusion Criteria:

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

  1. Subjects with an existing diabetic foot ulcer
  2. Subjects determined "at risk" for an ulcer

Exclusion Criteria:

  1. History of heart failure
  2. Rheumatoid arthritis
  3. Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341559


Locations
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United States, California
Keck Medical Center of USC
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Modulated Imaging Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Armstrong, Professor of Surgery and Director, Southwestern Academic Limb Salvage Alliance (SALSA), University of Southern California
ClinicalTrials.gov Identifier: NCT03341559    
Other Study ID Numbers: APP-17-06886
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases