NCT04572945

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

September 27, 2020

Last Update Submit

March 21, 2021

Conditions

CKDDiabetic Foot

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1- Cases: Diabetic patients with CKD.

classified according to estimated GFR into 5 stages according to KIDGO 2012 classification.

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.

Diagnostic Test: kidney function test

Interventions

kidney function testDIAGNOSTIC_TEST

laboratory and imaging

Also known as: HB A1c, urine analysis, abd us
1- Cases: Diabetic patients with CKD.2- Controls: Diabetic patients without CKD.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 32144399BACKGROUND

  • 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.

    PMID: 22348369BACKGROUND

  • 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.

    PMID: 20532700BACKGROUND

  • 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.

    PMID: 23642720BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Interventions

Kidney Function TestsUrinalysis

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, UrologicalDiagnostic Techniques and ProceduresDiagnosisClinical Chemistry TestsClinical Laboratory TechniquesInvestigative Techniques

Study Officials

  • usra mo farrag, M.B.B.ch

    eygpt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Usra mo Farrag, M.B.B.ch

CONTACT

01013460518usramohamed24@gmail.com

Effat ab Toni, Prof.

CONTACT

01097330309effattoni@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2020

First Posted

October 1, 2020

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

March 24, 2021

Record last verified: 2021-03