Clinical Trials Directory

Trials / Unknown

UnknownNCT04572945

Foot Abnormalities in Diabetic CKD Patients

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

Status
Unknown
Phase
Study type
Observational
Enrollment
58 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTkidney function testlaboratory and imaging

Timeline

Start date
2021-04-01
Primary completion
2022-04-01
Completion
2022-04-01
First posted
2020-10-01
Last updated
2021-03-24

Source: ClinicalTrials.gov record NCT04572945. Inclusion in this directory is not an endorsement.