Predictors of Diabetic Foot Outcome in Chronic Kidney Disease Patients

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.

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Key information

Conditions

Diabetic Foot Disease Chronic Disease Chronic Kidney Disease Due to Type 2 Diabetes Mellitus Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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 .

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle Brachial Index

Other

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.

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Mahmoud Zaky osman, resident doctors

CONTACT

[email protected]

+201102218610

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Nov 12, 2024
Registry last updated: Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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