Predictors of Diabetic Foot Outcome in Chronic Kidney Disease Patients

NCT ID: NCT06684886

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-01-30

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 .

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

diabetic foot group

diabetic nephropathy patients with diabetic foot

Ankle Brachial Index

Intervention Type: 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.

non diabetic foot group

diabetic nephropathy patients without diabetic foot

Ankle Brachial Index

Intervention Type: 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.

Interventions

Ankle Brachial Index

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Eman Mahmoud Zaki Osman

resident doctor at nephrology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Eman Mahmoud Zaky osman, resident doctors

Role: CONTACT

Em827185@gmail.com

+201102218610

References

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.

Reference Type: RESULT

PMID: 17961157 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38519239 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35257052 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23117208 (View on PubMed)

Other Identifiers

diabetic foot CKD in patients

Identifier Type: -

Identifier Source: org_study_id