NCT05845242|Not Yet Recruiting
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Sponsor study identifier
observational
80
0 countries
N/A
Study Start
August 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Diabetic foot ulcers are one of the complications of diabetes mellitus. These wounds are often the result of diabetes-related neuropathy and/or an ischemic foot. Even with great care, recurrent ulcers are common. To mediate the damage and societal costs that come with DF there is a need for applications to detect ulcers before they come apparent. Two of these promising techniques are Laser Speckle Contrast imaging and thermography. This study is part of 4 specific clinical studies and is aimed at determining Laser Speckle Contrast imaging and thermography features, the provocations that are needed to optimize imaging and the correlation between these features and the IWGDF risk stratification category system for the diabetic foot.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 6, 2023
Actual (reported)May 6, 2023
Actual (reported)August 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Perfusion units at various regions of interest using LSCI
Maps of perfusion units will be gathered for different risk groups. The perfusion units will be used to create risk features together with thermography .
During one outpatient visit (30 minutes)
Temperature at various regions of interest using thermography
Maps of perfusion units will be gathered for different risk groups. The Temperature will be used to create risk features together with perfusion units from LSCI .
During one outpatient visit (30 minutes)
The effect of provocations performed prior to measuring with LSCI
For both LSCI and thermography the circulation in the leg will be provoked using the leg raise maneuver or a pressure cuff. The effect on both measurements with and without these provocations will be evaluated.
During one outpatient visit (30 minutes)
The effect of provocations performed prior to measuring with thermography
For both LSCI and thermography the circulation in the leg will be provoked using the leg raise maneuver or a pressure cuff. The effect on both measurements with and without these provocations will be evaluated.
During one outpatient visit (30 minutes)
Gathering data for AI (artificial intelligence) risk factor analysis in MYFOOT study
Year 4
Assessing the practical needs for transferring measurements to a different environment (e.g., home) by interviewing the clinicians involved in the consortium.
Year 3
Very low ulcer risk: No LOPS (loss of peripheral sensation) and No PAD (peripheral arterial disease)
Low ulcer risk: LOPS or PAD
Moderate ulcer risk: LOPS + PAD, or LOPS + foot deformity or PAD + foot deformity
High ulcer risk: LOPS or PAD, and one or more of the following: * history of a foot ulcer * a lower-extremity amputation (minor or major) * end-stage renal disease
All patients with diabetic foot, receiving check-ups at the out-patient clinic at ZGT in Almelo, The Netherlands.
Kilian Kappert, PhD
ZGT
First Submitted
April 6, 2023
First Posted
May 6, 2023
Study Start
August 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2027
Diabetic Foot Self Care
Correlation of the above features with the chance of developing ulcers (Risk 0, Risk 1, Risk 2 and Risk 3).
A first attempt will be made to find a correlation between perfusion and temperature and how these differ depending on the risk factor.
Year 4
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 6, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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