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

NCT ID: NCT05845242

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2028-10-01

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.

Conditions

Diabetic Foot

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Risk 0

Very low ulcer risk: No LOPS (loss of peripheral sensation) and No PAD (peripheral arterial disease)

No interventions assigned to this group

Risk 1

Low ulcer risk: LOPS or PAD

No interventions assigned to this group

Risk 2

Moderate ulcer risk: LOPS + PAD, or LOPS + foot deformity or PAD + foot deformity

No interventions assigned to this group

Risk 3

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Twente

OTHER

Sponsor Role: collaborator

Ziekenhuisgroep Twente

OTHER

Sponsor Role: lead

Responsible Party

KilianKappert

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kilian Kappert, PhD

Role: PRINCIPAL_INVESTIGATOR

ZGT

Central Contacts

Kilian Kappert, PhD

Role: CONTACT

k.kappert@zgt.nl

+31657915596

Wiendelt Steenbergen, PhD

Role: CONTACT

w.steenbergen@utwente.nl

+31534893160

Other Identifiers

ZGT_MYFOOT_LSCI

Identifier Type: -

Identifier Source: org_study_id