Foot Abnormalities in Diabetic CKD Patients

Study Overview
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Brief Summary
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To find the correlation between different stages of CKD and type and severity of foot abnormalities in diabetic patients with CKD. To assess factors that may aggravate foot abnormalities in diabetic patients with CKD by measuring serum calcium, phosphorus, parathyroid hormone, albumin, uric acid…etc.

Detailed Description
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Chronic kidney disease is an important contributor to morbidity and mortality, the global prevalence of CKD was 9.1% (697.5 million cases) in 2017(1). Diabetes is a leading cause of end stage renal disease worldwide. (2) Foot abnormalities and amputation are major health concerns as they diminish health-related quality of life and cause financial burden (3). KDIGO 2020 defines Chronic Kidney Disease (CKD) as persistently elevated urine albumin excretion (≥30 mg/g [3mg/mmol] creatinine), persistently reduced estimated glomerular filtration rate (eGFR <60 ml/min per 1.73 m2), or both, for greater than 3 months. (4) Diabetic foot is defined as either diabetic peripheral neuropathy, peripheral arterial disease, infection, ulceration, or Charcot osteoarthropathy, or a combination of these abnormalities, in a person diagnosed with diabetes mellitus, according to the guidelines of International Working Group of Diabetic Foot 2020 (IWGDF). (5) There is a much higher incidence of diabetic foot disorder in those with renal disease and outcomes are generally poorer (2) as CKD patients are sharing three main risk factors of foot ulceration and amputation: neuropathy, peripheral arterial disease and increased susceptibility to infection with impaired wound healing. (6) this research is conducted as little is known about the potential relationship between chronic kidney disease and diabetic foot. This research evaluates the true burden of different diabetic foot lesions in CKD patients, assesses the severity of diabetic foot in different stages of CKD and the factors that may aggravate it in CKD, for future need to modify our clinical policies in management of diabetic foot in CKD patients to provide better prognosis and prevent long term disabilities.

Official Title
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Foot Abnormalities in Diabetic Patients With and Without Chronic Kidney Disease in Assuit University Hospitals; Case Control Study

Conditions
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CKD, Diabetic Foot

Intervention / Treatment
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* Diagnostic Test: kidney function test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic CKD patients classified according to estimated GFR into 5 stages according to KIDGO 2012 classification: Stage 1 CKD: eGFR 90 or Greater Stage 2 CKD: eGFR Between 60 and 89 Stage 3 CKD: eGFR Between 30 and 59 Stage 4 CKD: eGFR Between 15 and 29 Stage 5 CKD: eGFR Less than 15 etheir on dialysis ( satge 5 D) or not (stage 5 non D) Age more than ≥18 years Exclusion Criteria: Patients administer drugs causing neuropathy as:amiodarone, chemotherapy, oxazolidinone linezolid, isoniazid, metronidazole, nitrofurantoin ,immunosuppressants, nucleoside reverse transcriptase inhibitors, levodopa and antifungal drugs. Patients with other causes of CKD. Patients have other causes of PVD. Age less than ˂18 years. Patients' refusal to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1- Cases: Diabetic patients with CKD.<br>classified according to estimated GFR into 5 stages according to KIDGO 2012 classification. | Diagnostic Test: kidney function test<br>* laboratory and imaging<br>* Other names: abd us;|
| 2- Controls: Diabetic patients without CKD.<br>defined as patients who have normal kidney function test, normal urine analysis and normal ultrasound findings. | Diagnostic Test: kidney function test<br>* laboratory and imaging<br>* Other names: abd us;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of foot abnormalities in diabetic CKD patient | Percentage of foot abnormalities in diabetic CKD patient in different stages according to KIDGO 2012 classification | 1 year |