WithdrawnNot Applicable

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

Stopped: MY FOOT study proposal was submitted for the HORIZON-HLTH-2023-TOOL-05-03 call, but the project was not approved

0Started 2023-04-13

Plain-language 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. 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under ROC curve generated by the statistical model able to discriminate between healing and not healing ulcers

Timeframe: at 26 weeks after the first visit in patients affected by the first ulcer

Trial details

NCT IDNCT05791929

SponsorMario Negri Institute for Pharmacological Research

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10-10

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials