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

NCT07139184 | Not Yet Recruiting

• 1 other identifier: AMAAmrMohammedAli
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Charcot Foot Diabetes Mellitus TNF alpha IL 10

Outcome Measures

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.

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

  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.

  one year

Study Arms (2)

The case group: (30 cases)

is comprised of patients with diabetes mellitus suffering from Charcot foot and diagnosed clinically.

Diagnostic Test: Diagnosis of Charcot foot disease; Diagnostic Test: Hematologic and biochemical parameters,; Diagnostic Test: ELIZA Assay

The control group: (30 cases)

is comprised DM patients without Charcot foot.

Diagnostic Test: Hematologic and biochemical parameters,; Diagnostic Test: ELIZA Assay

Interventions

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

The case group: (30 cases)

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).

The case group: (30 cases); The control group: (30 cases)

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.

The case group: (30 cases); The control group: (30 cases)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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
• Patients with chronic renal impairment due to diseases other than DM (creatinine \> 1.4 mg/dL), previous myocardial infarction or stroke, history of cancer.
• Patients with iron deficiency anemia or uremia affecting HbA1c levels or elevated triglyceride or bilirubin levels.
• Patients diagnosed with neurological disease, malignancy.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Roglic G. WHO Global report on diabetes: A summary. International Journal of Noncommunicable Diseases. 2016;1(1):3-8.

  BACKGROUND

• Silva LB, dos Santos Neto AP, Maia SMAS, dos Santos Guimarães C, Quidute IL, Carvalho AdAT, et al. The Role of TNF-α as a Proinflammatory Cytokine in Pathological Processes. The Open Dentistry Journal. 2019;13:332-8.

  BACKGROUND

• Pratistha I, Kawiyana K, Aryana W. Duration of Type II DM, HbA1C Levels, TNF-α and IL-10 as Risk Factors for Level Charcot Joint Foot and Ankle in Type II DM Patients. International Journal of Health Sciences and Research. 2022;12:147-56.

  BACKGROUND

• Uslu MF, Yilmaz M. Are Inflammatory Markers Important for Assessing the Severity of Diabetic Polyneuropathy? Medicina (Kaunas). 2025 Feb 25;61(3):400. doi: 10.3390/medicina61030400.

  PMID: 40142211 BACKGROUND

• Rosenbaum AJ, DiPreta JA. Classifications in brief: Eichenholtz classification of Charcot arthropathy. Clin Orthop Relat Res. 2015 Mar;473(3):1168-71. doi: 10.1007/s11999-014-4059-y. Epub 2014 Nov 21. No abstract available.

  PMID: 25413713 BACKGROUND

• Garcia-Dominguez M. The Role of TNF-alpha in Neuropathic Pain: An Immunotherapeutic Perspective. Life (Basel). 2025 May 14;15(5):785. doi: 10.3390/life15050785.

  PMID: 40430212 BACKGROUND

• Carlini V, Noonan DM, Abdalalem E, Goletti D, Sansone C, Calabrone L, Albini A. The multifaceted nature of IL-10: regulation, role in immunological homeostasis and its relevance to cancer, COVID-19 and post-COVID conditions. Front Immunol. 2023 Jun 8;14:1161067. doi: 10.3389/fimmu.2023.1161067. eCollection 2023.

  PMID: 37359549 BACKGROUND

• Bobirca A, Musetescu AE, Bordianu A, Pantea Stoian A, Salmen T, Marinescu DC, Alexandru C, Florescu A, Radu R, Isac S, Patrascu T, Serban D, Bobirca F. Novel Biomarkers Predictive of Diabetic Charcot Foot-An Overview of the Literature. Life (Basel). 2022 Nov 21;12(11):1944. doi: 10.3390/life12111944.

  PMID: 36431079 BACKGROUND

• Schmidt BM. Clinical insights into Charcot foot. Best Pract Res Clin Rheumatol. 2020 Jun;34(3):101563. doi: 10.1016/j.berh.2020.101563. Epub 2020 Jul 5.

  PMID: 32641254 BACKGROUND

• Dardari D. An overview of Charcot's neuroarthropathy. J Clin Transl Endocrinol. 2020 Oct 28;22:100239. doi: 10.1016/j.jcte.2020.100239. eCollection 2020 Dec.

  PMID: 33251117 BACKGROUND

• Casadei G, Filippini M, Brognara L. Glycated Hemoglobin (HbA1c) as a Biomarker for Diabetic Foot Peripheral Neuropathy. Diseases. 2021 Feb 22;9(1):16. doi: 10.3390/diseases9010016.

  PMID: 33671807 BACKGROUND

• Wukich DK, Schaper NC, Gooday C, Bal A, Bem R, Chhabra A, Hastings M, Holmes C, Petrova NL, Santini Araujo MG, Senneville E, Raspovic KM. Guidelines on the diagnosis and treatment of active Charcot neuro-osteoarthropathy in persons with diabetes mellitus (IWGDF 2023). Diabetes Metab Res Rev. 2024 Mar;40(3):e3646. doi: 10.1002/dmrr.3646. Epub 2023 May 23.

  PMID: 37218537 BACKGROUND

• Farmaki P, Damaskos C, Garmpis N, Garmpi A, Savvanis S, Diamantis E. Complications of the Type 2 Diabetes Mellitus. Curr Cardiol Rev. 2020;16(4):249-251. doi: 10.2174/1573403X1604201229115531. No abstract available.

  PMID: 33407062 BACKGROUND

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Dr. Refaat Fathy Abdel-Aal Naseer, Prof

CONTACT

+201011121526; refaat.fathy@med.aun.edu.eg

Mohammed Hasan Mohammed AbdEllah-Alawi, Dr.

CONTACT

+201115353591; mhmdifferent@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share