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Risk Factor Analysis for Charcot Foot in Patients With Diabetes Mellitus: The Interplay of Inflammatory Cytokines and Metabolic Factors

NCT07139184 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-08-24

No results posted yet for this study

Summary

Diabetes mellitus (DM) is among the most common metabolic disorders globally. According to the data from international research, the number of persons with diabetes mellitus reached 366 million in 2011 and is predicted to increase to 552 million by 2030.

Conditions

  • Charcot Foot

Interventions

DIAGNOSTIC_TEST

Diagnosis of Charcot foot disease

Diagnosis of Charcot foot disease will be obtained from the results of physical examination and according to x-ray examination of foot which was performed at the Radiology Department of Assiut University Hospital. The Eichenholtz classification system, developed by Sidney N. Eichenholtz in 1966, categorizes Charcot arthropathy (also known as Charcot foot) into three stages based on clinical and radiographic findings. These stages are development, coalescence, and reconstruction

DIAGNOSTIC_TEST

Hematologic and biochemical parameters,

Hematologic and biochemical parameters, including lymphocyte, monocyte, neutrophil, and platelet counts, as well as glucose, HbA1c, triglyceride (TG), HDL, and LDL levels, will be extracted from patient records. NLR=absolute neutrophil count (109/L)/absolute lymphocyte count (109/L), PLR=platelet count (109/L)/absolute lymphocyte count (109/L), LMR=absolute lymphocyte count (109/L)/absolute monocyte count (109/L), GLR=glucose (mg/dL)/absolute lymphocyte ratio (109/L), TGR=triglyceride (mg/dL)/glucose ratio (mg/dL), THR=triglyceride (mg/dL)/HDL ratio (mg/dL), SIRI = absolute neutrophil count (109/L) × absolute monocyte count (109/L)/ absolute lymphocyte count (109/L), SII = platelet count (109/L) × absolute monocyte count (109/L)/absolute lymphocyte count (109/L), TyG index = fasting triglyceride (mg/dL) × fasting plasma glucose (mg/dL)/2, PIV =absolute neutrophil count (109/L) × platelet count (109/L) × absolute monocyte count (109/L)/absolute lymphocyte count (109/L).

DIAGNOSTIC_TEST

ELIZA Assay

For each patient, 2 ml of blood will be obtained. The serum levels of IL-10, TNF-α will be assessed by using (ELISA) kit obtained from (Biodiagnostic company, Egypt) according to the manufacturer protocol.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-10-31
Completion
2027-10-31

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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 NCT07139184 on ClinicalTrials.gov