Diabetes Mellitus, Type 2MY-FOOT-BNCT05791929
LSCI and Thermography in Diabetic Foot Patients Affected by Ulcer(s): (MY-FOOT-B)
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Mario Negri Institute for Pharmacological Research.
Trial summary
The objective of this observational study is to predict healing at 26 weeks after the first visit in patients affected by the first ulcer, by means of combined data monitoring of Laser Speckle Contrast Imaging (LSCI) and temperature measurements during patient visits in hospital. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Ulcer Foot
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Apr 2023to 4 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetes mellitus and suffering from ulcer and receiving health care at study participating hospitals
Who may be able to join
- a confirmed diagnosis of type 1 or type 2 diabetes mellitus (more than 5 years from diagnosis),
- aged between 18 and 80 years,
- patients affected by one foot ulcer (defined as break of the skin of the foot that involves at least the epidermis and part of the dermis )
- signed informed consent.
Who cannot join
- having multiple foot ulcers,
- having an amputation of the forefoot or an amputation at a more proximal location of the foot (e.g., midfoot or hindfoot),
- severe foot infection (IWGDF grade 4),
- being incapacitated or undergoing cancer treatment.
About this study
Official title: Image Features of LSCI and Thermography for Prediction of Healing Trajectory in Diabetic Foot Patients Affected by the First (or Successive) Ulcer: (MY-FOOT-B)
The objective of this observational study is to predict healing at 26 weeks after the first visit in patients affected by the first ulcer, by means of combined data monitoring of Laser Speckle Contrast Imaging (LSCI) and temperature measurements during patient visits in hospital.
In order to achieve this objective, study aims to produce a logistic regression model and then evaluate its prognostic ability by means of the area under the curve (AUC) of the receiver-operating-characteristics (ROC) curve.
Patients with diabetes mellitus and suffering from ulcer and receiving health care will undergo regular microcirculatory measurements including LSCI scans in and around the ulcer location and thermography.
Read the detailed description
The study aims to predict healing at 26 weeks after the first visit in patients affected by the first ulcer, by means of combined data monitoring of Laser Speckle Contrast Imaging (LSCI) and temperature measurements during patient visits in hospital.
In order to achieve this objective, the study aims to produce a logistic regression model and then evaluate its prognostic ability by means of the area under the curve (AUC) of the receiver-operating-characteristics (ROC) curve.
The variables evaluated for the model will include demographic and baseline characteristics of the patients, location and seriousness of the ulcer, alongside LSCI and temperature measurements at baseline and different timepoints. The development of the model will include a rigorous variables selection in order to produce a parsimonious model.
In the method proposed by Mennes, LSCI measurements at baseline, biological zero, post occlusion peak, and other parameters like non-invasive blood pressure measurements were individually evaluated as possible prognostic factors of healing trajectory at 26 weeks. All these parameters, when assessed at their highest possible value of sensibility and specificity, produced AUCs always inferior to 0.65. The highest value of AUC (0.625) was reached by toe pressure parameter when calculated using a threshold value of 54 mmHg.
From diagnostic literature, an AUC of ≥ 0.8 is considered excellent result, while an AUC < 0.7 is considered less than acceptable. Since the Mennes's method showed these results, study investigators set the AUC resulting from the model under the null hypothesis (H0) to be equal to 0.65. By including all these parameters, alongside the other mentioned variables, in a single prognostic model, study investigators expect to increase this prognostic ability. Therefore, in this study, investigators would like to detect an AUC ≥ 0.8 (H1). With these hypotheses, a power of 80%, a one-sided I type error of 5% and a prevalence of 43% of healed patients at 26 weeks, a total of 82 patients should be enrolled.
- Keywords
- Diabetes, Ulcer foot, LSCI, Thermography
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Foot Ulcer, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under ROC curve generated by the statistical model able to discriminate between healing and not healing ulcers
to discriminate between healing and not healing ulcers by means of combined data monitoring of Laser Speckle Contrast Imaging (LSCI) and temperature measurements during patient visits in hospital
Measured: at 26 weeks after the first visit in patients affected by the first ulcer
Secondary outcomes (2)
The predictive positive and negative value related to the score test, based of calculation of likelihood ratio.
The predictive positive and negative value related to the score test, based of calculation of likelihood ratio.
Measured: at 26 weeks after the first visit in patients affected by the first ulcer
The AUC of the models estimated according to different sites of ulcers.
The AUC of the models estimated according to different sites of ulcers.
Measured: at 26 weeks after the first visit in patients affected by the first ulcer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start13 Apr 2023
- Primary completion10 Oct 2023 (estimated)
- Study completion4 Dec 2023
Why it stopped: MY FOOT study proposal was submitted for the HORIZON-HLTH-2023-TOOL-05-03 call, but the project was not approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cesare Miranda, MD, Principal investigator, Pordenone Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791929
- Sponsor's protocol ID
- MY-FOOT-B
- Acronym
- MY-FOOT-B
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is a plan to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Features of LSCI and Thermography for Prediction of Healing Trajectory in Diabetic Foot Patients Affected by the First (or Successive) Ulcer: (MY-FOOT-B)
- ClinicalTrials.gov ID
- NCT05791929
- Acronym / sponsor ID
- MY-FOOT-B / MY-FOOT-B
- Keywords
- Diabetes, Ulcer foot, LSCI, Thermography
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: MY FOOT study proposal was submitted for the HORIZON-HLTH-2023-TOOL-05-03 call, but the project was not approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 30 Mar 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.
The objective of this observational study is to predict healing at 26 weeks after the first visit in patients affected by the first ulcer, by means of combined data monitoring of Laser Speckle Contrast Imaging (LSCI) and temperature measurements during patient visits in hospital.
In order to achieve this objective, study aims to produce a logistic regression model and then evaluate its prognostic ability by means of the area under the curve (AUC) of the receiver-operating-characteristics (ROC) curve.
Patients with diabetes mellitus and suffering from ulcer and receiving health care will undergo regular microcirculatory measurements including LSCI scans in and around the ulcer location and thermography.
Detailed description
The study aims to predict healing at 26 weeks after the first visit in patients affected by the first ulcer, by means of combined data monitoring of Laser Speckle Contrast Imaging (LSCI) and temperature measurements during patient visits in hospital.
In order to achieve this objective, the study aims to produce a logistic regression model and then evaluate its prognostic ability by means of the area under the curve (AUC) of the receiver-operating-characteristics (ROC) curve.
The variables evaluated for the model will include demographic and baseline characteristics of the patients, location and seriousness of the ulcer, alongside LSCI and temperature measurements at baseline and different timepoints. The development of the model will include a rigorous variables selection in order to produce a parsimonious model.
In the method proposed by Mennes, LSCI measurements at baseline, biological zero, post occlusion peak, and other parameters like non-invasive blood pressure measurements were individually evaluated as possible prognostic factors of healing trajectory at 26 weeks. All these parameters, when assessed at their highest possible value of sensibility and specificity, produced AUCs always inferior to 0.65. The highest value of AUC (0.625) was reached by toe pressure parameter when calculated using a threshold value of 54 mmHg.
From diagnostic literature, an AUC of ≥ 0.8 is considered excellent result, while an AUC < 0.7 is considered less than acceptable. Since the Mennes's method showed these results, study investigators set the AUC resulting from the model under the null hypothesis (H0) to be equal to 0.65. By including all these parameters, alongside the other mentioned variables, in a single prognostic model, study investigators expect to increase this prognostic ability. Therefore, in this study, investigators would like to detect an AUC ≥ 0.8 (H1). With these hypotheses, a power of 80%, a one-sided I type error of 5% and a prevalence of 43% of healed patients at 26 weeks, a total of 82 patients should be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes mellitus and suffering from ulcer and receiving health care at study participating hospitals
Key inclusion criteria (4 listed)
- a confirmed diagnosis of type 1 or type 2 diabetes mellitus (more than 5 years from diagnosis),
- aged between 18 and 80 years,
- patients affected by one foot ulcer (defined as break of the skin of the foot that involves at least the epidermis and part of the dermis )
- signed informed consent.
Key exclusion criteria (4 listed)
- having multiple foot ulcers,
- having an amputation of the forefoot or an amputation at a more proximal location of the foot (e.g., midfoot or hindfoot),
- severe foot infection (IWGDF grade 4),
- being incapacitated or undergoing cancer treatment.
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
Area Under ROC curve generated by the statistical model able to discriminate between healing and not healing ulcers
Time frame: at 26 weeks after the first visit in patients affected by the first ulcer
to discriminate between healing and not healing ulcers by means of combined data monitoring of Laser Speckle Contrast Imaging (LSCI) and temperature measurements during patient visits in hospital
2 secondary outcomes
The predictive positive and negative value related to the score test, based of calculation of likelihood ratio.
Time frame: at 26 weeks after the first visit in patients affected by the first ulcer
The AUC of the models estimated according to different sites of ulcers.
Time frame: at 26 weeks after the first visit in patients affected by the first ulcer
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No. There is a plan to make individual participant data (IPD) available to other researchers
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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. This study is not recruiting at the moment.
Cesare Miranda, MD principal investigator
Pordenone Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Mario Negri Institute for Pharmacological Research.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 15 Mar 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under ROC curve generated by the statistical model able to discriminate between healing and not healing ulcers (time frame: at 26 weeks after the first visit in patients affected by the first ulcer). 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 15 Mar 2024.