Predictors of Diabetic Foot Outcome in Chronic Kidney Disease Patients

NCT06684886 | Not Yet Recruiting DMC

• 1 other identifier: diabetic foot CKD in patients
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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

  baseline

Study Arms (2)

diabetic foot group

diabetic nephropathy patients with diabetic foot

Other: Ankle Brachial Index

non diabetic foot group

diabetic nephropathy patients without diabetic foot

Other: Ankle Brachial Index

Interventions

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.

diabetic foot group; non diabetic foot group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 17961157 RESULT

• 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.

  PMID: 38519239 RESULT

• 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.

  PMID: 35257052 RESULT

• Gutekunst DJ, Smith KE, Commean PK, Bohnert KL, Prior FW, Sinacore DR. Impact of Charcot neuroarthropathy on metatarsal bone mineral density and geometric strength indices. Bone. 2013 Jan;52(1):407-13. doi: 10.1016/j.bone.2012.10.028. Epub 2012 Oct 29.

  PMID: 23117208 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eman Mahmoud Zaky osman, resident doctors

CONTACT

+201102218610; Em827185@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at nephrology department

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 30, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11