Image Features of LSCI and Thermography for Determining the Risk Factor (0,1,2 and 3) of Developing Diabetic Foot Ulcer

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Perfusion units at various regions of interest using LSCI [Срок оценки: During one outpatient visit (30 minutes)]
• Temperature at various regions of interest using thermography [Срок оценки: During one outpatient visit (30 minutes)]
• The effect of provocations performed prior to measuring with LSCI [Срок оценки: During one outpatient visit (30 minutes)]
• The effect of provocations performed prior to measuring with thermography [Срок оценки: During one outpatient visit (30 minutes)]
• Correlation of the above features with the chance of developing ulcers (Risk 0, Risk 1, Risk 2 and Risk 3). [Срок оценки: Year 4]

Вторичные конечные точки (2)

• Gathering data for AI (artificial intelligence) risk factor analysis in MYFOOT study [Срок оценки: Year 4]
• Assessing the practical needs for transferring measurements to a different environment (e.g., home) by interviewing the clinicians involved in the consortium. [Срок оценки: Year 3]

Критерии участия

Критерии включения

• 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).

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05845242 · ZGT_MYFOOT_LSCI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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