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

NCT05791929 | Withdrawn DMC

• 1 other identifier: MY-FOOT-B
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Diabetes; Ulcer foot; LSCI; Thermography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diabetes mellitus and suffering from ulcer and receiving health care at study participating hospitals

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• Cesare Miranda, MD

  Pordenone Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: April 13, 2023
• Primary Completion: October 10, 2023
• Study Completion: December 4, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share