Diabetes Mellitus, Type 2 Clinical Trial
— MY-FOOT-BOfficial 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)
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Status | Withdrawn |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 |
Verified date | March 2024 |
Source | Mario Negri Institute for Pharmacological Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 4, 2023 |
Est. primary completion date | October 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mario Negri Institute for Pharmacological Research |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under ROC curve generated by the statistical model able to discriminate between healing and not healing ulcers | to discriminate between healing and not healing ulcers by means of combined data monitoring of Laser Speckle Contrast Imaging (LSCI) and temperature measurements during patient visits in hospital | at 26 weeks after the first visit in patients affected by the first ulcer | |
Secondary | The predictive positive and negative value related to the score test, based of calculation of likelihood ratio. | The predictive positive and negative value related to the score test, based of calculation of likelihood ratio. | at 26 weeks after the first visit in patients affected by the first ulcer | |
Secondary | The AUC of the models estimated according to different sites of ulcers. | The AUC of the models estimated according to different sites of ulcers. | at 26 weeks after the first visit in patients affected by the first ulcer |
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