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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05845242
• Other study ID #: ZGT_MYFOOT_LSCI
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: October 1, 2028

Study information

• Verified date: May 2023
• Source: Ziekenhuisgroep Twente
• Contact: Kilian Kappert, PhD
• Phone: +31657915596
• Email: k.kappert[@]zgt.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 1, 2028
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ziekenhuisgroep Twente	University of Twente

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Secondary	Gathering data for AI (artificial intelligence) risk factor analysis in MYFOOT study	Data will be gathered for other work packages in the consortium that focus on creating a model for clinical decision making.	Year 4
Secondary	Assessing the practical needs for transferring measurements to a different environment (e.g., home) by interviewing the clinicians involved in the consortium.	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.	Year 3