跳至主要内容
临床试验/NCT06684886
NCT06684886尚未招募不适用

Predictors of Diabetic Foot Outcome in Chronic Kidney Disease Patients

Assiut University0 个研究点目标入组 60 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Ankle brachial index as a predictor for diabetic foot

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Ankle brachial index as a predictor for diabetic foot

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Mahmoud Zaki Osman

resident doctor at nephrology department

Assiut University

相似试验