- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04572945
Foot Abnormalities in Diabetic CKD Patients
Foot Abnormalities in Diabetic Patients With and Without Chronic Kidney Disease in Assuit University Hospitals; Case Control Study
- 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
The research includes patients recruited from Internal Medicine department Assiut University Hospitals( renal and dialysis unit and diabetes and endocrinal center) , classified into two groups :
- diabetic CKD patient (stage 1- stage 5 non D )
- diabetic CKD patient (stage 5 D)
- written or verbal consent should be taken from those patients that participate in the study.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
1- Cases: Diabetic patients with CKD.
classified according to estimated GFR into 5 stages according to KIDGO 2012 classification.
|
laboratory and imaging
Andre navne:
|
|
2- Controls: Diabetic patients without CKD.
defined as patients who have normal kidney function test, normal urine analysis and normal ultrasound findings.
|
laboratory and imaging
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of foot abnormalities in diabetic CKD patient
Tidsramme: 1 year
|
Percentage of foot abnormalities in diabetic CKD patient in different stages according to KIDGO 2012 classification
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: usra mo farrag, M.B.B.ch, eygpt
Publikationer og nyttige links
Generelle publikationer
- Carney EF. The impact of chronic kidney disease on global health. Nat Rev Nephrol. 2020 May;16(5):251. doi: 10.1038/s41581-020-0268-7. No abstract available.
- Valabhji J. Foot problems in patients with diabetes and chronic kidney disease. J Ren Care. 2012 Feb;38 Suppl 1:99-108. doi: 10.1111/j.1755-6686.2012.00284.x.
- Ndip A, Lavery LA, Boulton AJ. Diabetic foot disease in people with advanced nephropathy and those on renal dialysis. Curr Diab Rep. 2010 Aug;10(4):283-90. doi: 10.1007/s11892-010-0128-0.
- Hammond N, Wang Y, Dimachkie MM, Barohn RJ. Nutritional neuropathies. Neurol Clin. 2013 May;31(2):477-89. doi: 10.1016/j.ncl.2013.02.002.
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Diabetic Foot in CKD patients
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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