CKDNCT04572945
Foot Abnormalities in Diabetic CKD Patients
An observational study of CKD and Diabetic Foot, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD, Diabetic Foot
- What is being tested?
- kidney function test
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- CKD, Diabetic Foot
- Being tested
- kidney function test
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kidney function testDiagnostic test
Also called HB A1c, urine analysis, abd us
laboratory and imaging
| Study group | Role | What they receive |
|---|---|---|
| 1- Cases: Diabetic patients with CKD. | classified according to estimated GFR into 5 stages according to KIDGO 2012 classification. Receives: Diagnostic Test: kidney function test | |
| 2- Controls: Diabetic patients without CKD. | defined as patients who have normal kidney function test, normal urine analysis and normal ultrasound findings. Receives: Diagnostic Test: kidney function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of foot abnormalities in diabetic CKD patient
Percentage of foot abnormalities in diabetic CKD patient in different stages according to KIDGO 2012 classification
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CKDStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usra Mohamed Farrag Ahmed, Assiut University
- Investigators
- usra mo farrag, M.B.B.ch, Principal investigator, eygpt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572945
- Sponsor's protocol ID
- Diabetic Foot in CKD patients
- Status last verified
- Mar 2021
- First submitted
- 27 Sep 2020
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32144399Valabhji 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.
PubMed 22348369Ndip 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.
PubMed 20532700Hammond 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.
PubMed 23642720
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Abnormalities in Diabetic Patients With and Without Chronic Kidney Disease in Assuit University Hospitals; Case Control Study
- ClinicalTrials.gov ID
- NCT04572945
- Acronym / sponsor ID
- Diabetic Foot in CKD patients
- Conditions
- CKD, Diabetic Foot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 1 Oct 2020 (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.
- 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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- Cases: Diabetic patients with CKD. | – | Diagnostic Test: kidney function testclassified according to estimated GFR into 5 stages according to KIDGO 2012 classification. |
| 2- Controls: Diabetic patients without CKD. | – | Diagnostic Test: kidney function testdefined as patients who have normal kidney function test, normal urine analysis and normal ultrasound findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| kidney function testAlso: HB A1c, urine analysis, abd uslaboratory and imaging | Diagnostic test | 1- Cases: Diabetic patients with CKD., 2- Controls: Diabetic patients without CKD. |
Primary outcome
Percentage of foot abnormalities in diabetic CKD patient
Time frame: 1 year
Percentage of foot abnormalities in diabetic CKD patient in different stages according to KIDGO 2012 classification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Background: PubMed 32144399Carney 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.
- Background: PubMed 22348369Valabhji 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.
- Background: PubMed 20532700Ndip 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.
- Background: PubMed 23642720Hammond 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.
Related trials for CKD
RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
RecruitingObservational study
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Gastric Antral Vascular Ectasia, Cirrhosis
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
RecruitingPhase 2
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Pruritus, Chronic Kidney Diseases
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. This study is not recruiting at the moment.
usra mo farrag, M.B.B.ch principal investigator
eygpt
Questions about this trial
What is this clinical trial studying?
An observational study of CKD and Diabetic 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Usra mo Farrag, M.B.B.ch (01013460518, usramohamed24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of foot abnormalities in diabetic CKD patient (time frame: 1 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 NCT04572945, which also lists 4 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 Mar 2021.