Clinical trial NCT05845242: Image Features of LSCI and Thermography for Determining the Risk Factor (0,1,2 and 3) of Developing Diabetic Foot Ulcer
Official title: Image Features of LSCI and Thermography for Determining the Risk Factor (0,1,2 and 3) of Developing Diabetic Foot Ulcer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Foot
Keywords: diabetic foot
diabetes
LSCI
thermography
Lead sponsor: Ziekenhuisgroep Twente
Sponsor class: OTHER
Collaborators: name: University of Twente
First posted: 2023-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with diabetic foot, receiving check-ups at the out-patient clinic at ZGT in Almelo, The Netherlands.

Brief summary: 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.

Detailed description: 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. Diabetic feet (DF) are ideally treated by a multidisciplinary wound care team. Patients at high risk and especially patients that suffer from DF before will have to be checked regularly for new wounds.

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. To improve care, an application to predict the healing status is desired.

To this purpose, a set of four (4) specific clinical studies has been conceived to tackle the overall challenging objectives to characterise the risk of ulcers in different patients and through different measurement conditions, including conditions of how a tele-home care service can be deployed. This is clinical study A.

This study investigates two techniques:

Laser speckle contrast imaging (LSCI) is a promising non-invasive technique to assess microcirculation. LSCI, exploits the random speckle pattern that is generated when tissue is illuminated by laser light and changes when blood cells move in the sampled tissue.

Thermography is used to measure temperature distribution on the foot. It is expected that soon-to-be affected regions will be warmer than other regions. Also, regions with impaired blood supply can be recognized.

Clinical study A aims 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.

Eligibility criteria: Inclusion Criteria:

* The sample will include all the people who sign the informed consent.
* Patients above 18. Patients diagnosed with Diabetic feet.
* Patients with Risk Level 0, 1, 2 and 3 according to the International Working Group on the Diabetic Foot - IWGDF).

Exclusion Criteria:

* People who do not give their consent to participate in the study.
* Patients with active wounds on one or both feet.

Primary outcomes:
measure: Perfusion units at various regions of interest using LSCI
timeFrame: During one outpatient visit (30 minutes)
measure: Temperature at various regions of interest using thermography
timeFrame: During one outpatient visit (30 minutes)
measure: The effect of provocations performed prior to measuring with LSCI
timeFrame: During one outpatient visit (30 minutes)
measure: The effect of provocations performed prior to measuring with thermography
timeFrame: During one outpatient visit (30 minutes)
measure: Correlation of the above features with the chance of developing ulcers (Risk 0, Risk 1, Risk 2 and Risk 3).
timeFrame: Year 4
Secondary outcomes:
measure: Gathering data for AI (artificial intelligence) risk factor analysis in MYFOOT study
timeFrame: Year 4
measure: Assessing the practical needs for transferring measurements to a different environment (e.g., home) by interviewing the clinicians involved in the consortium.
timeFrame: Year 3
Other outcomes:
Locations:
Study officials:
affiliation: ZGT
name: Kilian Kappert, PhD
role: PRINCIPAL_INVESTIGATOR
References: