Clinical trial NCT04572945: Foot Abnormalities in Diabetic CKD Patients
Official title: Foot Abnormalities in Diabetic Patients With and Without Chronic Kidney Disease in Assuit University Hospitals; Case Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CKD
Diabetic Foot
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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 :

  1. diabetic CKD patient (stage 1- stage 5 non D )
  2. diabetic CKD patient (stage 5 D)
* written or verbal consent should be taken from those patients that participate in the study.

Brief summary: 1. To find the correlation between different stages of CKD and type and severity of foot abnormalities in diabetic patients with CKD.
2. 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 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)
2. Age more than ≥18 years

Exclusion Criteria:

1. Patients administer drugs causing neuropathy as:amiodarone, chemotherapy, oxazolidinone linezolid, isoniazid, metronidazole, nitrofurantoin ,immunosuppressants, nucleoside reverse transcriptase inhibitors, levodopa and antifungal drugs.
2. Patients with other causes of CKD.
3. Patients have other causes of PVD.
4. Age less than ˂18 years.
5. Patients' refusal to participate in the study.

Primary outcomes:
measure: Percentage of foot abnormalities in diabetic CKD patient
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: eygpt
name: usra mo farrag, M.B.B.ch
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.