Clinical trial NCT06684886: Predictors of Diabetic Foot Outcome in Chronic Kidney Disease Patients
Official title: Predictors of Diabetic Foot Outcome in Chronic Kidney Disease Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Foot Disease
Chronic Kidney Disease Due to Type 2 Diabetes Mellitus
Keywords: chronic kidney disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief summary: 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.

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Ankle brachial index as a predictor for diabetic foot
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Abbas ZG, Archibald LK. Challenges for management of the diabetic foot in Africa: doing more with less. Int Wound J. 2007 Dec;4(4):305-13. doi: 10.1111/j.1742-481X.2007.00376.x. Epub 2007 Oct 24.
citation: Levin A, Ahmed SB, Carrero JJ, Foster B, Francis A, Hall RK, Herrington WG, Hill G, Inker LA, Kazancioglu R, Lamb E, Lin P, Madero M, McIntyre N, Morrow K, Roberts G, Sabanayagam D, Schaeffner E, Shlipak M, Shroff R, Tangri N, Thanachayanont T, Ulasi I, Wong G, Yang CW, Zhang L, Robinson KA, Wilson L, Wilson RF, Kasiske BL, Cheung M, Earley A, Stevens PE. Executive summary of the KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease: known knowns and known unknowns. Kidney Int. 2024 Apr;105(4):684-701. doi: 10.1016/j.kint.2023.10.016.
citation: Bonnet JB, Sultan A. Narrative Review of the Relationship Between CKD and Diabetic Foot Ulcer. Kidney Int Rep. 2021 Dec 21;7(3):381-388. doi: 10.1016/j.ekir.2021.12.018. eCollection 2022 Mar.
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