NCT06684886|Not Yet RecruitingDMC
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Sponsor study identifier
observational
60
0 countries
N/A
Study Start
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 10, 2024
Actual (reported)November 12, 2024
Actual (reported)December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
diabetic nephropathy patients with diabetic foot
diabetic nephropathy patients without diabetic foot
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.
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diabetic nephropathy patients will be divided into two groups ( DF and non-DF groups, 30 patients for each group).
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.
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.
First Submitted
November 10, 2024
First Posted
November 12, 2024
Study Start
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2025
Implementation of a Diabetic Foot Prevention Strategy in Primary Care (iMplanta Study)
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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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 12, 2024
Record last verified: 2024-11
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