About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult Patients who are diagnosed with DM who are willing to participate in the study with informed consent form.

Disqualifiers

Patients with neuritis / neuropathy of the lower extremity due to other causes other than DM

Significant trauma that may cause peripheral nerve damage.

Patient with routine use of corticosteroid

Previous history of smoking

Trial population

Patients' data and medical conditions (name, age, gender, occupation, residence, smoking habits, use of corticosteroids, long history of diabetes mellitus, and other diseases such as hyperlipidemia, hypertension, foot and ankle fracture, and peripheral artery disease) were obtained from the Outpatient Clinic in Assiut University Hospital.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Diagnosis of Charcot foot disease
Diagnostic test
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
Hematologic and biochemical parameters,
Diagnostic test
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).
ELIZA Assay
Diagnostic test
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: The case group: (30 cases)3 interventions

Group B: The control group: (30 cases)2 interventions

Trial outcomes

Primary outcomes

1

The study will investigate the role of IL-10 and TNF-alpha as novel biomarkers for early detection of acute Charcot foot disease.

Time frame

one year

Secondary outcomes

1

The current work will demonstrate the role of inflammatory markers, glycaemic control, lipid profile, and several other risk factors to predict the occurrence of Charcot foot disease.