Predictors of Diabetic Foot Outcome in Chronic Kidney Disease Patients

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

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Age ≥18 years old.

TYPE 2 DM with or without DF .

Patients are at different stages of CKD as defined according to KDIGO (9).

Disqualifiers

- Patients on dialysis or CKD stage 5 (GFR < 15 ml/min)

Patients with kidney transplant

Pregnant patients

Type 1 DM

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Ankle Brachial Index
Other intervention
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: diabetic foot group1 intervention

Group B: non diabetic foot group1 intervention

Trial outcomes

Primary outcomes

Ankle brachial index as a predictor for diabetic foot

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

Time frame

baseline

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: