Diabetic FootNCT05845242
Image Features of LSCI and Thermography for Determining the Risk Factor (0,1,2 and 3) of Developing Diabetic Foot Ulcer
An observational study of Diabetic Foot, run by Ziekenhuisgroep Twente.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with diabetic foot, receiving check-ups at the out-patient clinic at ZGT in Almelo, The Netherlands.
Who may be able to join
- 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).
Who cannot join
- People who do not give their consent to participate in the study.
- Patients with active wounds on one or both feet.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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. 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.
Read the 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
- Keywords
- diabetic foot, diabetes, LSCI, thermography
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Risk 0 | Very low ulcer risk: No LOPS (loss of peripheral sensation) and No PAD (peripheral arterial disease) | |
| Risk 1 | Low ulcer risk: LOPS or PAD | |
| Risk 2 | Moderate ulcer risk: LOPS + PAD, or LOPS + foot deformity or PAD + foot deformity | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: During one outpatient visit (30 minutes)
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 .
Measured: During one outpatient visit (30 minutes)
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.
Measured: During one outpatient visit (30 minutes)
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.
Measured: 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).
A first attempt will be made to find a correlation between perfusion and temperature and how these differ depending on the risk factor.
Measured: Year 4
Secondary outcomes (2)
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.
Measured: Year 4
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.
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuisgroep Twente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente
- Responsible party
- Principal investigator, KilianKappert, Ziekenhuisgroep Twente
- Investigators
- Kilian Kappert, PhD, Principal investigator, ZGT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845242
- Sponsor's protocol ID
- ZGT_MYFOOT_LSCI
- Status last verified
- May 2023
- First submitted
- 6 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Features of LSCI and Thermography for Determining the Risk Factor (0,1,2 and 3) of Developing Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT05845242
- Acronym / sponsor ID
- ZGT_MYFOOT_LSCI
- Conditions
- Diabetic Foot
- Keywords
- diabetic foot, diabetes, LSCI, thermography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ziekenhuisgroep TwenteUniversity, hospital or other
- Collaborators
- University of Twente
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Risk 0 | – | –Very low ulcer risk: No LOPS (loss of peripheral sensation) and No PAD (peripheral arterial disease) |
| Risk 1 | – | –Low ulcer risk: LOPS or PAD |
| Risk 2 | – | –Moderate ulcer risk: LOPS + PAD, or LOPS + foot deformity or PAD + foot deformity |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with diabetic foot, receiving check-ups at the out-patient clinic at ZGT in Almelo, The Netherlands.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- People who do not give their consent to participate in the study.
- Patients with active wounds on one or both feet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 .
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 .
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.
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.
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.
2 secondary outcomes
Gathering data for AI (artificial intelligence) risk factor analysis in MYFOOT study
Time frame: Year 4
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
Related trials for Diabetic Foot
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kilian Kappert, PhD principal investigator
ZGT
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot, run by Ziekenhuisgroep Twente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kilian Kappert, PhD (+31657915596, k.kappert@zgt.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion units at various regions of interest using LSCI (time frame: During one outpatient visit (30 minutes)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.