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

NCT05791929 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1
  • Ulcer Foot

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Cesare Miranda, MD · Pordenone Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2023-10-10
Completion
2023-12-04

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05791929 on ClinicalTrials.gov