Predictors of Diabetic Foot Outcome in Chronic Kidney Disease Patients

November 11, 2024 updated by: Eman Mahmoud Zaki Osman, Assiut University

Individuals with diabetic neuropathy and Chronic kidney disease (CKD) are 15 times more likely to have a non-traumatic lower extremity amputation compared to those with DM alone . The incidence of DF and its evolution appear to be proportionally related to the stage of CKD . One of the most important causes is vascular calcification, which is common in patients with atherosclerosis, DM, CKD, and elderly .

Various factors, including age, gender, infection severity, local ischemia, diabetes duration, neuropathy, and blood sugar control, are considered potential predictors for DF outcome. However, there remains a lack of complete this study aim to Assessment of predictors of diabetic foot development and outcome in chronic kidney disease patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

About 537 million adults are living with diabetes mellitus (DM). This number is predicted to rise to 643 million by 2030 . Diabetic foot (DF), being one of the most prevalent, severe, and costly complications of DM. It is primarily characterized by skin infections, ulcers, or destruction of deep tissues below the ankle joint. It is commonly associated with neuropathy or vascular disorders in the lower extremities, and in severe cases, it may involve muscles and bones . Ultimately, 19% to 34% of patients with diabetes will suffer from DF during their lifetimes . Around 20% of DF patients may require lower limb amputations, which can be either minor (below the ankle joint) or major (above the ankle joint), and sometimes both .

Individuals with diabetic neuropathy and Chronic kidney disease (CKD) are 15 times more likely to have a non-traumatic lower extremity amputation compared to those with DM alone . The incidence of DF and its evolution appear to be proportionally related to the stage of CKD . One of the most important causes is vascular calcification, which is common in patients with atherosclerosis, DM, CKD, and elderly .

Various factors, including age, gender, infection severity, local ischemia, diabetes duration, neuropathy, and blood sugar control, are considered potential predictors for DF outcome. However, there remains a lack of complete understanding regarding the most significant factors and their respective impact on the outcome .

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eman Mahmoud Zaky osman, resident doctors
  • Phone Number: +201102218610
  • Email: Em827185@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

diabetic nephropathy patients will be divided into two groups ( DF and non-DF groups, 30 patients for each group).

Description

Inclusion Criteria:

  • - Age ≥18 years old.
  • TYPE 2 DM with or without DF .
  • Patients are at different stages of CKD as defined according to KDIGO (9).

Exclusion Criteria:

  • - Patients on dialysis or CKD stage 5 (GFR < 15 ml/min)
  • Patients with kidney transplant
  • Pregnant patients
  • Type 1 DM

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diabetic foot group
diabetic nephropathy patients with diabetic foot
Other: Ankle Brachial Index

Normal ABI ranges from 1.0 - 1.4

  • Pressure is normally higher in the ankle than the arm.
  • Values above 1.4 suggest a noncompressible calcified vessel.
  • In diabetic or elderly patients, the limb vessels may be fibrotic or calcified. In this case, the vessel may be resistant to collapse by the blood pressure cuff, and a signal may be heard at high cuff pressures. The persistence of a signal at a high pressure in these individuals results in an artifactually elevated blood pressure value.
  • An value below 0.9 is considered diagnostic of PAD.
  • Values less than 0.5 suggests severe PAD.
  • Individuals with such severe disease may not have sufficient blood flow to heal a fracture or surgical wound; they should be considered for revascularization if they have a non-healing ulcer.
non diabetic foot group
diabetic nephropathy patients without diabetic foot
Other: Ankle Brachial Index

Normal ABI ranges from 1.0 - 1.4

  • Pressure is normally higher in the ankle than the arm.
  • Values above 1.4 suggest a noncompressible calcified vessel.
  • In diabetic or elderly patients, the limb vessels may be fibrotic or calcified. In this case, the vessel may be resistant to collapse by the blood pressure cuff, and a signal may be heard at high cuff pressures. The persistence of a signal at a high pressure in these individuals results in an artifactually elevated blood pressure value.
  • An value below 0.9 is considered diagnostic of PAD.
  • Values less than 0.5 suggests severe PAD.
  • Individuals with such severe disease may not have sufficient blood flow to heal a fracture or surgical wound; they should be considered for revascularization if they have a non-healing ulcer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle brachial index as a predictor for diabetic foot
Time Frame: baseline
Ankle brachial index is calculated for each leg. The ABI value is determined by taking the higher pressure of the 2 arteries at the ankle, divided by the brachial arterial systolic pressure. In calculating the ABI, the higher of the two brachial systolic pressure measurements is used. In normal individuals, there should be a minimal (less than 10 mm Hg) interarm systolic pressure gradient during a routine examination. A consistent difference in pressure between the arms greater than 10mmHg is suggestive of (and greater than 20mmHg is diagnostic of) subclavian or axillary arterial stenosis, which may be observed in individuals at risk for atherosclerosis
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Estimated)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diabetic foot CKD in patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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