Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05791929
Status:
WITHDRAWN
Last Update Posted:
2024-03-15
First Post:
2023-03-17
Brief Title:
LSCI and Thermography in Diabetic Foot Patients Affected by Ulcers MY-FOOT-B
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Mario Negri Institute for Pharmacological Research
Study Overview
Official Title:
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
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
MY FOOT study proposal was submitted for the HORIZON-HLTH-2023-TOOL-05-03 call but the project was not approved
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MY-FOOT-B
Brief 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
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
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 065 The highest value of AUC 0625 was reached by toe pressure parameter when calculated using a threshold value of 54 mmHg
From diagnostic literature an AUC of 08 is considered excellent result while an AUC 07 is considered less than acceptable Since the Menness method showed these results study investigators set the AUC resulting from the model under the null hypothesis H0 to be equal to 065 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 08 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
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 065 The highest value of AUC 0625 was reached by toe pressure parameter when calculated using a threshold value of 54 mmHg
From diagnostic literature an AUC of 08 is considered excellent result while an AUC 07 is considered less than acceptable Since the Menness method showed these results study investigators set the AUC resulting from the model under the null hypothesis H0 to be equal to 065 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 08 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None