Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT05791929 |
Other study ID # |
MY-FOOT-B |
Secondary ID |
|
Status |
Withdrawn |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 13, 2023 |
Est. completion date |
December 4, 2023 |
Study information
Verified date |
March 2024 |
Source |
Mario Negri Institute for Pharmacological Research |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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.
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.
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.