LSCI and Thermography in Diabetic Foot Patients Affected by Ulcer(s): (MY-FOOT-B) (MY-FOOT-B)

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Ulcer Foot

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 Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with diabetes mellitus and suffering from ulcer and receiving health care at study participating hospitals

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 26 weeks after the first visit in patients affected by the first ulcer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at 26 weeks after the first visit in patients affected by the first ulcer

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Investigators: Principal Investigator: Cesare Miranda, MD, Pordenone Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): October 10, 2023
• Study Completion (Actual): December 4, 2023

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Thermography; LSCI; Ulcer foot
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetic Neuropathies; Foot Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetic Foot; Foot Ulcer; Ulcer; Diabetes Mellitus, Type 1
• Other Study ID Numbers: MY-FOOT-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is a plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No