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 range18 Years – 80 Years

SexALL

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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.

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