Charcot FootRFA-CF-DM-ICMFNCT07139184
Risk Factor Analysis for Charcot Foot in Patients With Diabetes Mellitus: The Interplay of Inflammatory Cytokines and Metabolic Factors
An observational study of Charcot Foot, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Charcot Foot
- What is being tested?
- Diagnosis of Charcot foot disease, Hematologic and biochemical parameters, and ELIZA Assay
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Adult Patients who are diagnosed with DM who are willing to participate in the study with informed consent form.
- Exclusion criteria:
- 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
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Hyperglycaemia is a hallmark of diabetes mellitus resulting from defects in insulin secretion, insulin action, or both. Diabetes-related chronic hyperglycaemia is linked to long-term harm complications and failure of several organs, particularly the heart, blood vessels, kidneys, eyes, and nerves and even the musculoskeletal system Charcot neuroarthropathy, is a condition that develops in people with diabetes and neuropathy, causing damage to the bones and joints in the foot There are several risk factors for developing Charcot foot in patients with DM, such as age, gender, duration of diabetes mellitus, blood pressure, blood lipid levels, smoking, and levels of HbA1c. However, little is known about the most significant risk factor to develop such debilitating Charcot foot disease.
Acute Charcot arthritis is also characterized by a marked inflammatory response. Several chronic pro-inflammatory markers are elevated in affected individuals including interleukin-1β, interleukin 6, and tumour necrosis factor-α, and increased receptor activation of nuclear factor-K β ligand, which is imbalanced with its receptor and osteoprotegerin.
Interleukin-10 (IL-10) is a multifunctional cytokine that plays a key role in controlling inflammation and preserving cellular balance. Its primary function is anti-inflammatory, helping to prevent excessive immune reactions by acting mainly through the Jak1/Tyk2 and STAT3 signaling pathway. However, IL-10 can also act as an immune activator under certain conditions, showing stimulatory effects that support immune responses in specific conditions. Given the pivotal role of IL-10 in immune modulation, this cytokine could have relevant implications in pathologies characterized by hyperinflammatory state such as Charcot foot disease.
TNF-α is a member of the vast cytokine family being considered a proinflammatory substance produced many by macrophages and other cells belonging to the innate immunity, many of them classified as indeed Antigen Presenting Cells (APCs) involved in the complex chemotactic process of activation of the adaptive immunity. Elevated levels of TNF-α have been implicated in the development and progression of various neuropathies, including those associated with diabetes.
Although Charcot foot disease is a frequent complication of diabetic neuropathy, less is known about the possibility of its early prevention. This research aims to highlight potentially important early identifiable biomarkers that can lead to Charcot foot disease in patients with DM.
- Conditions
- Charcot Foot
- Being tested
- Diagnosis of Charcot foot disease, Hematologic and biochemical parameters,, ELIZA Assay
- Keywords
- Charcot Foot Diabetes Mellitus TNF alpha IL 10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of Charcot foot diseaseDiagnostic 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 AssayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| The case group: (30 cases) | is comprised of patients with diabetes mellitus suffering from Charcot foot and diagnosed clinically. Receives: 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. Receives: Diagnostic Test: Hematologic and biochemical parameters,; Diagnostic Test: ELIZA Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Charcot FootStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Ali Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139184
- Sponsor's protocol ID
- AMAAmrMohammedAli
- Acronym
- RFA-CF-DM-ICMF
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roglic G. WHO Global report on diabetes: A summary. International Journal of Noncommunicable Diseases. 2016;1(1):3-8.
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.
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.
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.
PubMed 40142211Rosenbaum 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.
PubMed 25413713Garcia-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.
PubMed 40430212Carlini 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.
PubMed 37359549Bobirca 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.
PubMed 36431079Schmidt 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.
PubMed 32641254Dardari 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.
PubMed 33251117Casadei 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.
PubMed 33671807Wukich 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.
PubMed 37218537Farmaki 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.
PubMed 33407062
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factor Analysis for Charcot Foot in Patients With Diabetes Mellitus: The Interplay of Inflammatory Cytokines and Metabolic Factors
- ClinicalTrials.gov ID
- NCT07139184
- Acronym / sponsor ID
- RFA-CF-DM-ICMF / AMAAmrMohammedAli
- Conditions
- Charcot Foot
- Keywords
- Charcot Foot Diabetes Mellitus TNF alpha IL 10
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hyperglycaemia is a hallmark of diabetes mellitus resulting from defects in insulin secretion, insulin action, or both. Diabetes-related chronic hyperglycaemia is linked to long-term harm complications and failure of several organs, particularly the heart, blood vessels, kidneys, eyes, and nerves and even the musculoskeletal system Charcot neuroarthropathy, is a condition that develops in people with diabetes and neuropathy, causing damage to the bones and joints in the foot There are several risk factors for developing Charcot foot in patients with DM, such as age, gender, duration of diabetes mellitus, blood pressure, blood lipid levels, smoking, and levels of HbA1c. However, little is known about the most significant risk factor to develop such debilitating Charcot foot disease.
Acute Charcot arthritis is also characterized by a marked inflammatory response. Several chronic pro-inflammatory markers are elevated in affected individuals including interleukin-1β, interleukin 6, and tumour necrosis factor-α, and increased receptor activation of nuclear factor-K β ligand, which is imbalanced with its receptor and osteoprotegerin.
Interleukin-10 (IL-10) is a multifunctional cytokine that plays a key role in controlling inflammation and preserving cellular balance. Its primary function is anti-inflammatory, helping to prevent excessive immune reactions by acting mainly through the Jak1/Tyk2 and STAT3 signaling pathway. However, IL-10 can also act as an immune activator under certain conditions, showing stimulatory effects that support immune responses in specific conditions. Given the pivotal role of IL-10 in immune modulation, this cytokine could have relevant implications in pathologies characterized by hyperinflammatory state such as Charcot foot disease.
TNF-α is a member of the vast cytokine family being considered a proinflammatory substance produced many by macrophages and other cells belonging to the innate immunity, many of them classified as indeed Antigen Presenting Cells (APCs) involved in the complex chemotactic process of activation of the adaptive immunity. Elevated levels of TNF-α have been implicated in the development and progression of various neuropathies, including those associated with diabetes.
Although Charcot foot disease is a frequent complication of diabetic neuropathy, less is known about the possibility of its early prevention. This research aims to highlight potentially important early identifiable biomarkers that can lead to Charcot foot disease in patients with DM.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The case group: (30 cases) | – | Diagnostic Test: Diagnosis of Charcot foot disease, Diagnostic Test: Hematologic and biochemical parameters,, Diagnostic Test: ELIZA Assayis comprised of patients with diabetes mellitus suffering from Charcot foot and diagnosed clinically. |
| The control group: (30 cases) | – | Diagnostic Test: Hematologic and biochemical parameters,, Diagnostic Test: ELIZA Assayis comprised DM patients without Charcot foot. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Adult Patients who are diagnosed with DM who are willing to participate in the study with informed consent form.
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of Charcot foot diseaseDiagnosis 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 | The case group: (30 cases) |
| 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 | The case group: (30 cases), The control group: (30 cases) |
| ELIZA AssayFor 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. | Diagnostic test | The case group: (30 cases), The control group: (30 cases) |
Primary outcome
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
The study will investigate the role of IL-10 and TNF-alpha as novel biomarkers for early detection of acute Charcot foot disease.
1 secondary outcome
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.
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- BackgroundRoglic G. WHO Global report on diabetes: A summary. International Journal of Noncommunicable Diseases. 2016;1(1):3-8.
- BackgroundSilva 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.
- BackgroundPratistha 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: PubMed 40142211Uslu 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.
- Background: PubMed 25413713Rosenbaum 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.
- Background: PubMed 40430212Garcia-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.
- Background: PubMed 37359549Carlini 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.
- Background: PubMed 36431079Bobirca 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.
- Background: PubMed 32641254Schmidt 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.
- Background: PubMed 33251117Dardari 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.
- Background: PubMed 33671807Casadei 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.
- Background: PubMed 37218537Wukich 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.
- Individual participant dataSharing planned: No
Related trials for Charcot Foot
Not yet recruitingObservational study
Muscle MRI Fat Fraction Before Surgery to Predict Strength Recovery After Foot-Drop Surgery in Charcot-Marie-Tooth Disease
Foot Drop, Charcot-Marie-Tooth Disease Type 1A
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
RecruitingPhase 3
The DENOCHARCOT Trial
Charcot Foot, Diabetes Mellitus
Recruiting
Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy
Charcot Neuroarthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Charcot Foot, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Refaat Fathy Abdel-Aal Naseer, Prof (+201011121526, refaat.fathy@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07139184, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.