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NCT Number: NCT05845242

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

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Perfusion units at various regions of interest using LSCI

    Time frame: During one outpatient visit (30 minutes)

    Maps of perfusion units will be gathered for different risk groups. The perfusion units will be used to create risk features together with thermography .

  2. Temperature at various regions of interest using thermography

    Time frame: During one outpatient visit (30 minutes)

    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 .

  3. The effect of provocations performed prior to measuring with LSCI

    Time frame: During one outpatient visit (30 minutes)

    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.

  4. The effect of provocations performed prior to measuring with thermography

    Time frame: During one outpatient visit (30 minutes)

    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.

  5. Correlation of the above features with the chance of developing ulcers (Risk 0, Risk 1, Risk 2 and Risk 3).

    Time frame: Year 4

    A first attempt will be made to find a correlation between perfusion and temperature and how these differ depending on the risk factor.

Secondary outcomes

  1. Gathering data for AI (artificial intelligence) risk factor analysis in MYFOOT study

    Time frame: Year 4

    Data will be gathered for other work packages in the consortium that focus on creating a model for clinical decision making.

  2. Assessing the practical needs for transferring measurements to a different environment (e.g., home) by interviewing the clinicians involved in the consortium.

    Time frame: Year 3

    Other work packages in the greater MYFOOT consortium focus on transferring technologies from the hospital to the patient's home. Based on the workflow created in this study and the expert opinion of the clinicians involved in the consortium it will be decided if and how LSCI and thermography can be measured at a patient's home.

Study contacts

Contact information is provided by the study sponsor or research team.

Kilian Kappert, PhD

CONTACT

[email protected]

+31657915596

Wiendelt Steenbergen, PhD

CONTACT

[email protected]

+31534893160

Sponsors and collaborators

Lead sponsor

Ziekenhuisgroep Twente

Other

Collaborators

  • University of Twente

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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