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Predictors of Diabetic Foot Outcome in Chronic Kidney Disease Patients

A

Assiut University

Status

Not yet enrolling

Conditions

Chronic Kidney Disease Due to Type 2 Diabetes Mellitus
Diabetic Foot Disease

Treatments

Other: Ankle Brachial Index

Study type

Observational

Funder types

Other

Identifiers

NCT06684886
diabetic foot CKD in patients

Details and patient eligibility

About

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.

Full 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 .

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

diabetic foot group
Description:
diabetic nephropathy patients with diabetic foot
Treatment:
Other: Ankle Brachial Index
non diabetic foot group
Description:
diabetic nephropathy patients without diabetic foot
Treatment:
Other: Ankle Brachial Index

Trial contacts and locations

0

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Central trial contact

Eman Mahmoud Zaky osman, resident doctors

Data sourced from clinicaltrials.gov

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