Risk factors for foot ulceration in adults with end-stage renal disease on dialysis: study protocol for a prospective observational cohort study

Journal of Foot and Ankle Research

Karl B. Landorf²  Bircan Erbas⁴  Lawrence P. McMahon¹  Anita Raspovic²  Michelle R. Kaminski³ 

[1] Departments of Renal Medicine and Obstetric Medicine, Eastern Health Clinical School, Monash University, Melbourne 3128, VIC, Australia;Discipline of Podiatry and Lower Extremity and Gait Studies Program, School of Allied Health, La Trobe University, Melbourne 3086, VIC, Australia;Department of Podiatry, Eastern Health, Melbourne 3156, VIC, Australia;Department of Public Health, College of Science, Health and Engineering, School of Psychology and Public Health, La Trobe University, Melbourne 3086, VIC, Australia

关键词: Prospective studies;    Risk factors;    Foot ulcer;    Dialysis;    Chronic;    Kidney failure;   

Others  :  1225691
DOI  :  10.1186/s13047-015-0110-9

 received in 2015-01-21, accepted in 2015-09-10,  发布年份 2015

【 摘 要 】

Background

Adults with end-stage renal disease treated with dialysis experience a high burden of foot ulceration and lower extremity amputation. However, the risk factors for foot ulceration in the dialysis population are incompletely understood due to the lack of high-quality prospective evidence. This article outlines the design of a prospective observational cohort study, which aims to investigate the risk factors for foot ulceration in adults on dialysis.

Methods/Design

This study will recruit 430 participants with end-stage renal disease on dialysis from satellite and home-therapy dialysis units across multiple health organisations in Melbourne, Victoria, Australia. Data collection at baseline will include a participant interview, medical record review, completion of a health-status questionnaire and a non-invasive foot assessment. Twenty participants will also be recruited to a reliability study to evaluate the reproducibility of testing procedures. Primary outcome data includes: new foot ulcer(s). Secondary outcome data includes: number of new foot ulcers, time to onset of new foot ulcer(s), new lower extremity amputation(s), episodes of infection of the foot or lower extremity, episodes of osteomyelitis, foot-related hospitalisations, revascularisation procedure(s) of the lower extremity, new podiatry interventions, kidney transplantation, and mortality. Participants will be assessed at baseline, and at 12 months they will be evaluated for the primary and secondary outcomes. Multivariate Cox proportional hazards models will be used to assess predictors of new foot ulceration and time to event secondary outcomes. Logistic regression will be used for binary outcomes including prevalence of foot ulcerations.

Discussion

This is the first multi-centre prospective observational cohort study to investigate risk factors for foot ulceration in adults with end-stage renal disease on dialysis. This study will improve on prior studies by using prospective methods, multi-centre recruitment, statistical methods to control for confounding variables, and a pre-specified sample size estimation. The findings can inform the design of future trials evaluating the effectiveness of clinical interventions, which may lead to improved patient outcomes in the dialysis setting.

【 授权许可】

   
2015 Kaminski et al.

【 图 表 】

Fig. 1.

【 参考文献 】

• [1]Krishnan AV, Kiernan MC. Uremic neuropathy: clinical features and new pathophysiological insights. Muscle Nerve. 2007; 35:273-90.
• [2]Moeller S, Gioberge S, Brown G. ESRD patients in 2001: global overview of patients, treatment modalities and development trends. Nephrol Dial Transplant. 2002; 17:2071-6.
• [3]Schieppati A, Remuzzi G. Chronic renal diseases as a public health problem: epidemiology, social, and economic implications. Kidney Int. 2005; 68:S7-10.
• [4]Eggers PW, Gohdes D, Pugh J. Nontraumatic lower extremity amputations in the Medicare end-stage renal disease population. Kidney Int. 1999; 56:1524-33.
• [5]Kaminski M, Frescos N, Tucker S. Prevalence of risk factors for foot ulceration in patients with end-stage renal disease on haemodialysis. Intern Med J. 2012; 42:e120-8.
• [6]Locking-Cusolito H, Harwood L, Wilson B, Burgess K, Elliot M, Gallo K, Ische J, Lawrence-Murphy JA, Ridley J, Robb M, Taylor C, Tigert J. Prevalence of risk factors predisposing to foot problems in patients on hemodialysis. Nephrol Nurs J. 2005; 32:373-84.
• [7]Margolis DJ, Hofstad O, Feldman HI. Association between renal failure and foot ulcer or lower-extremity amputation in patients with diabetes. Diabetes Care. 2008; 31:1331-6.
• [8]Ndip A, Lavery LA, Lafontaine J, Rutter MK, Vardhan A, Vileikyte L, Boulton AJ. High levels of foot ulceration and amputation risk in a multiracial cohort of diabetic patients on dialysis therapy. Diabetes Care. 2010; 33:878-80.
• [9]Ndip A, Rutter MK, Vileikyte L, Vardhan A, Asari A, Jameel M, Tahir HA, Lavery LA, Boulton AJ. Dialysis treatment is an independent risk factor for foot ulceration in patients with diabetes and stage 4 or 5 chronic kidney disease. Diabetes Care. 2010; 33:1811-6.
• [10]Pliakogiannis T, Bailey S, Cherukuri S, Taskapan H, Ahmad M, Oliver T, Bargman JM, Oreopoulos DG. Vascular complications of the lower extremities in diabetic patients on peritoneal dialysis. Clin Nephrol. 2008; 69:361-7.
• [11]Speckman RA, Frankenfield DL, Roman SH, Eggers PW, Bedinger MR, Rocco MV, McClellan WM. Diabetes is the strongest risk factor for lower-extremity amputation in new hemodialysis patients. Diabetes Care. 2004; 27:2198-203.
• [12]Jones NJ, Chess J, Cawley S, Phillips AO, Riley SG. Prevalence of risk factors for foot ulceration in a general haemodialysis population. Int Wound J. 2012. doi:. 10. 1111/j.1742-481X.2012.01044.x webcite
• [13]Hill MN, Feldman HI, Hilton SC, Holechek MJ, Ylitalo M, Benedict GW. Risk of foot complications in long-term diabetic patients with and without ESRD: A preliminary study. ANNA J. 1996; 23:381-6.
• [14]Lavery LA, Lavery DC, Hunt NA, La Fontaine J, Ndip A, Boulton AJ. Amputations and foot-related hospitalisations disproportionately affect dialysis patients. Int Wound J. 2013. doi:10.1111/iwj.12146.
• [15]Boulton AJM. The diabetic foot: grand overview, epidemiology and pathogenesis. Diabetes Metab Res Rev. 2008; 24 Suppl 1:S3-6.
• [16]Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005; 293:217-28.
• [17]Ragnarson Tennvall G, Apelqvist J. Health-related quality of life in patients with diabetes mellitus and foot ulcers. J Diabetes Complications. 2000; 14:235-41.
• [18]Lewis S, Raj D, Guzman NJ. Renal failure: Implications of chronic kidney disease in the management of the diabetic foot. Semin Vasc Surg. 2012; 25:82-8.
• [19]Valabhji J. Foot problems in patients with diabetes and chronic kidney disease. J Ren Care. 2012; 38:99-108.
• [20]Driver VR, Fabbi M, Lavery LA, Gibbons G. The costs of diabetic foot: the economic case for the limb salvage team. J Am Podiatr Med Assoc. 2010; 100:335-41.
• [21]Lazzarini PA, Gurr JM, Rogers JR, Schox A, Bergin SM. Diabetes foot disease: the Cinderella of Australian diabetes management? J Foot Ankle Res. 2012; 5:24. BioMed Central Full Text
• [22]Boulton AJM, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005; 366:1719-24.
• [23]Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014; 37:651-8.
• [24]Kaminski MR, Raspovic A, McMahon LP, Strippoli GFM, Palmer SC, Ruospo M, et al. Risk factors for foot ulceration and lower extremity amputation in adults with end-stage renal disease on dialysis: a systematic review and meta-analysis. Nephrol Dial Transplant. 2015; doi:10.1093/ndt/gfv114.
• [25]Portney LG, Watkins MP. Foundations of clinical research: applications to practice. 3rd ed. Pearson Education Inc, Upper Saddle River, NJ; 2009.
• [26]Abbott CA, Vileikyte L, Williamson S, Carrington AL, Boulton AJ. Multicenter study of the incidence of and predictive risk factors for diabetic neuropathic foot ulceration. Diabetes Care. 1998; 21:1071-5.
• [27]Boyko EJ, Ahroni JH, Cohen V, Nelson KM, Heagerty PJ. Prediction of diabetic foot ulcer occurrence using commonly available clinical information: the Seattle diabetic foot study. Diabetes Care. 2006; 29:1202-7.
• [28]Ribu L, Birkeland K, Hanestad BR, Moum T, Rustoen T. A longitudinal study of patients with diabetes and foot ulcers and their health-related quality of life: wound healing and quality-of-life changes. J Diabetes Complications. 2008; 22:400-7.
• [29]Ribu L, Hanestad BR, Moum T, Birkeland K, Rustoen T. Health-related quality of life among patients with diabetes and foot ulcers: association with demographic and clinical characteristics. J Diabetes Complications. 2007; 21:227-36.
• [30]McHorney CA, Ware JE, Lu JFR, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994; 32:40-66.
• [31]McHorney CA, Ware JE, Raczek AE. The MOS 36-item short-form health survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993; 31:247-63.
• [32]McHorney CA, Ware JE, Rogers W, Raczek AE, Lu JFR. The validity and relative precision of MOS short- and long-form health status scales and Dartmouth COOP charts. Results from the Medical Outcomes Study. Med Care. 1992; 30 Suppl 5:MS253-65.
• [33]Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care. 1992; 30:473-83.
• [34]Ware JE, Kosinski M, Bjorner JB, Turner-Bowker DM, Gandek B, Maruish ME. User’s manual for the SF-36v2® health survey. 2nd ed. QualityMetric Incorporated, Lincoln, RI; 2007.
• [35]Boulton AJM, Mueller MJ, Sheehan P, Wukich DK, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman SM, Lavery LA, Lemaster JW, Mills JL. Comprehensive foot examination and risk assessment: A report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care. 2008; 31:1679-85.
• [36]Feng Y, Schlösser FJ, Sumpio BE. The Semmes Weinstein monofilament examination as a screening tool for diabetic peripheral neuropathy. J Vasc Surg. 2009; 50:675-82.
• [37]Booth J, Young MJ. Differences in the performance of commercially available 10-g monofilaments. Diabetes Care. 2000; 23:984-8.
• [38]Feng Y, Schlösser FJ, Sumpio BE. The Semmes Weinstein monofilament examination is a significant predictor of the risk of foot ulceration and amputation in patients with diabetes mellitus. J Vasc Surg. 2011; 53:220-6.
• [39]Bakker K, Apelqvist J, Schaper NC. International Working Group on Diabetic Foot Editorial Board: Practical guidelines on the management and prevention of the diabetic foot 2011. Diabetes Metab Res Rev. 2012; 28:225-31.
• [40]Garrow AP, Boulton AJM. Vibration perception threshold - a valuable assessment of neural dysfunction in people with diabetes. Diabetes Metab Res Rev. 2006; 22:411-9.
• [41]Abbott CA, Johnson KE, Ryder CH, Torkington R, Van Ross ERE, Whalley AM, Widdows P, Williamson S, Boulton AJM, Carrington AL, Ashe H, Bath S, Every LC, Griffiths J, Hann AW, Hussein A, Jackson N. The North-West diabetes foot care study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort. Diabet Med. 2002; 19:377-84.
• [42]Young MJ, Breddy JL, Veves A, Boulton AJM. The prediction of diabetic neuropathic foot ulceration using vibration perception thresholds. A prospective study. Diabetes Care. 1994; 17:557-60.
• [43]Jayaprakash P, Bhansali A, Bhansali S, Dutta P, Anantharaman R, Shanmugasundar G, Ravikiran M. Validation of bedside methods in evaluation of diabetic peripheral neuropathy. Indian J Med Res. 2011; 133:645-9.
• [44]Garimella PS, Hart PD, O’Hare A, DeLoach S, Herzog CA, Hirsch AT. Peripheral artery disease and CKD: a focus on peripheral artery disease as a critical component of CKD care. Am J Kidney Dis. 2012; 60:641-54.
• [45]Leskinen Y, Salenius JP, Lehtimäki T, Huhtala H, Saha H. The prevalence of peripheral arterial disease and medial arterial calcification in patients with chronic renal failure: requirements for diagnostics. Am J Kidney Dis. 2002; 40:472-9.
• [46]Ng S-Y, Cheng S-W, Chu W-L, Lui S-L, Lo W-K. Screening by trained nurses for peripheral vascular disease in continuous ambulatory peritoneal dialysis patients with and without diabetes. Perit Dial Int. 2003; 23 Suppl 2:S134-8.
• [47]Hoyer C, Sandermann J, Petersen LJ. Randomised diagnostic accuracy study of a fully automated portable device for diagnosing peripheral arterial disease by measuring the toe-brachial index. Eur J Vasc Endovasc Surg. 2013; 45:57-64.
• [48]Pérez-Martin A, Meyer G, Demattei C, Böge G, Laroche JP, Quéré I, Dauzat M. Validation of a fully automatic photoplethysmographic device for toe blood pressure measurement. Eur J Vasc Endovasc Surg. 2010; 40:515-20.
• [49]Bhamidipaty V, Dean A, Yap SL, Firth J, Barron M, Allard B, Chan STF. Second toe systolic pressure measurements are valid substitutes for first toe systolic pressure measurements in diabetic patients: a prospective study. Eur J Vasc Endovasc Surg. 2015; 49:77-82.
• [50]Xu D, Zou L, Xing Y, Hou L, Wei Y, Zhang J, Qiao Y, Hu D, Xu Y, Li J, Ma Y. Diagnostic value of ankle-brachial index in peripheral arterial disease: a meta-analysis. Can J Cardiol. 2012; 29:492-8.
• [51]Young MJ, Every N, Boulton AJM. A comparison of the neurothesiometer and biothesiometer for measuring vibration perception in diabetic patients. Diabetes Res Clin Pract. 1993; 20:129-31.
• [52]Armstrong DWJ, Tobin C, Matangi MF. The accuracy of the physical examination for the detection of lower extremity peripheral arterial disease. Can J Cardiol. 2010; 26:e346-50.
• [53]O’Hare A, Johansen K. Lower-extremity peripheral arterial disease among patients with end-stage renal disease. J Am Soc Nephrol. 2001; 12:2838-47.
• [54]Takahara M, Kaneto H, Iida O, Katakami N, Matsuoka T-A, Ikeda M, Shimomura I. Association of diabetes and hemodialysis with ankle pressure and ankle-brachial index in Japanese patients with critical limb ischemia. Diabetes Care. 2012; 35:2000-4.
• [55]Reiber GE, Vileikyte L, Boyko EJ, del Aguila M, Smith DG, Lavery LA, Boulton AJ. Causal pathways for incident lower-extremity ulcers in patients with diabetes from two settings. Diabetes Care. 1999; 22:157-62.
• [56]Ledoux WR, Shofer JB, Smith DG, Sullivan K, Hayes SG, Assal M, Reiber GE. Relationship between foot type, foot deformity, and ulcer occurrence in the high-risk diabetic foot. J Rehabil Res Dev. 2005; 42:665-71.
• [57]Garrow AP, Papageorgiou A, Silman AJ, Thomas E, Jayson MIV, Macfarlane GJ. The grading of hallux valgus - the Manchester scale. J Am Podiatr Med Assoc. 2001; 91:74-8.
• [58]Menz HB, Munteanu SE. Radiographic validation of the Manchester scale for the classification of hallux valgus deformity. Rheumatology (Oxford). 2005; 44:1061-6.
• [59]Lavery LA, Armstrong DG, Vela SA, Quebedeaux TL, Fleischli JG. Practical criteria for screening patients at high risk for diabetic foot ulceration. Arch Intern Med. 1998; 158:157-62.
• [60]Hopson MM, McPoil TG, Cornwall MW. Motion of the first metatarsophalangeal joint. Reliability and validity of 4 measurement techniques. J Am Podiatr Med Assoc. 1995; 85:198-204.
• [61]Veves A, Murray HJ, Young MJ, Boulton AJ. The risk of foot ulceration in diabetic patients with high foot pressure: a prospective study. Diabetologia. 1992; 35:660-3.
• [62]Pham H, Armstrong DG, Harvey C, Harkless LB, Giurini JM, Veves A. Screening techniques to identify people at high risk for diabetic foot ulceration: a prospective multicenter trial. Diabetes Care. 2000; 23:606-11.
• [63]Kästenbauer T, Sauseng S, Sokol G, Auinger M, Irsigler K. A prospective study of predictors for foot ulceration in type 2 diabetes. J Am Podiatr Med Assoc. 2001; 91:343-50.
• [64]Zammit GV, Menz HB, Munteanu SE. Reliability of the TekScan MatScan(R) system for the measurement of plantar forces and pressures during barefoot level walking in healthy adults. J Foot Ankle Res. 2010; 3:11. BioMed Central Full Text
• [65]Barton CJ, Menz HB, Bonanno DR. Development and evaluation of a tool for the assessment of footwear characteristics. J Foot Ankle Res. 2009; 2:10. BioMed Central Full Text
• [66]Jennings MB, Logan L, Alfieri DM, Ross CF, Goodwin S, Lesczczynski C. A comparative study of lactic acid 10 % and ammonium lactate 12 % lotion in the treatment of foot xerosis. J Am Podiatr Med Assoc. 2002; 92:143-8.
• [67]Rogers RS, Callen J, Wehr R, Krochmal L. Comparative efficacy of 12 % ammonium lactate lotion and 5 % lactic acid lotion in the treatment of moderate to severe xerosis. J Am Acad Dermatol. 1989; 21:714-6.
• [68]Jennings MB, Alfieri D, Ward K, Lesczczynski C. Comparison of salicylic acid and urea versus ammonium lactate for the treatment of foot xerosis. A randomized, double-blind, clinical study. J Am Podiatr Med Assoc. 1998; 88:332-6.
• [69]Frowen P, O’Donnell M, Burrow GJ, Lorimer DL. Neale’s disorders of the foot. 8th ed. Churchill Livingstone/Elsevier, Edinburgh/New York; 2010.
• [70]Dyachenko P, Shustak A, Rozenman D. Hemodialysis-related pruritus and associated cutaneous manifestations. Int J Dermatol. 2006; 45:664-7.
• [71]Khanna D, Singal A, Kalra OP. Comparison of cutaneous manifestations in chronic kidney disease with or without dialysis. Postgrad Med J. 2010; 86:641-7.
• [72]Budisavljevic MN, Cheek D, Ploth DW. Calciphylaxis in chronic renal failure. J Am Soc Nephrol. 1996; 7:978-82.
• [73]Oyibo SO, Jude EB, Tarawneh I, Nguyen HC, Harkless LB, Boulton AJM. A comparison of two diabetic foot ulcer classification systems: The Wagner and the University of Texas wound classification systems. Diabetes Care. 2001; 24:84-8.
• [74]Rayman G, Krishnan ST, Baker NR, Wareham AM, Rayman A. Are we underestimating diabetes-related lower-extremity amputation rates? Results and benefits of the first prospective study. Diabetes Care. 2004; 27:1892-6.
• [75]Campbell LV, Graham AR, Kidd RM, Molloy HF, O’Rourke SR, Colagiuri S. The lower limb in people with diabetes: position statement of the Australian Diabetes Society. Med J Aust. 2000; 173:369-72.
• [76]Combe C, Jadoul M, Pisoni RL, Albert JM, Bragg-Gresham JL, Andreucci VE, Disney A, Fukuhara S, Goodkin DA, Gillespie BW, Saito A. The burden of amputation among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2009; 54:680-92.
• [77]Otte J, van Netten JJ, Woittiez AJ. The association of chronic kidney disease and dialysis treatment with foot ulceration and major amputation. J Vasc Surg. 2015. doi:10.1016/j.jvs.2015.02.051.
• [78]Kulkarni N, Pierse N, Rushton L, Grigg J. Carbon in airway macrophages and lung function in children. N Engl J Med. 2006; 355:21-30.
• [79]Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999; 8:135-60.
• [80]Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005; 85:257-68.
• [81]Tooth LR, Ottenbacher KJ. The kappa statistic in rehabilitation research: an examination. Arch Phys Med Rehabil. 2004; 85:1371-6.
• [82]Bernal Pedreño E, Salces Sáez E, Sambruno Giráldez A. Exploración del pie a los pacientes diabéticos de una unidad de hemodiálisis [Examination of the foot of diabetic patients in a haemodialysis unit]. Rev Soc Esp Enferm Nefrol. 2009; 12:111-6.
• [83]García Viejo A. Enfermedad arterial periférica y pié diabético en pacientes en programa de hemodiálisis [Peripheral arterial disease and diabetic foot in patients on haemodialysis programme]. Enferm Nefrol. 2012; 15:255-64.
• [84]Lancho Casares JM, Juan Larma T, de Vega JC, Nieto Guerrero M, Acedo Agúndez J. Patient on dialysis programme and peripheral arteriopathy [Paciente en programa de diálisis y arteriopatía periférica]. Rev Soc Esp Enferm Nefrol. 2008; 11:82-7.
• [85]Mark P, McNally M, Jones GC. Deficiencies in foot care of diabetic patients on renal replacement therapy. Pract Diab Int. 2003; 20:294-6.
• [86]McIntyre I, Boughen C, Trepman E, Embil JM. Foot and ankle problems of Aboriginal and non-Aboriginal diabetic patients with end-stage renal disease. Foot Ankle Int. 2007; 28:674-86.
• [87]Yasuhara H, Naka S, Yanagie H, Nagawa H. Influence of diabetes on persistent nonhealing ischemic foot ulcer in end-stage renal disease. World J Surg. 2002; 26:1360-4.
• [88]Schleiffer T, Hölken H, Brass H. Morbidity in 565 type 2 diabetic patients according to stage of nephropathy. J Diabetes Complications. 1998; 12:103-9.
• [89]Freeman A, May K, Frescos N, Wraight PR. Frequency of risk factors for foot ulceration in individuals with chronic kidney disease. Intern Med J. 2008; 38:314-20.
• [90]Wolf G, Müller N, Busch M, Eidner G, Kloos C, Hunger-Battefeld W, Müller UA. Diabetic foot syndrome and renal function in type 1 and 2 diabetes mellitus show close association. Nephrol Dial Transplant. 2009; 24:1896-901.
• [91]Armstrong DG. The 10-g monofilament: the diagnostic divining rod for the diabetic foot? Diabetes Care. 2000; 23:887.
• [92]Bonham PA. Get the LEAD out: noninvasive assessment for lower extremity arterial disease using ankle brachial index and toe brachial index measurements. J Wound Ostomy Continence Nurs. 2006; 33:30-41.
• [93]Romanos MT, Raspovic A, Perrin BM. The reliability of toe systolic pressure and the toe brachial index in patients with diabetes. J Foot Ankle Res. 2010. doi:. 10. 1186/1757-1146-3-31. webcite
• [94]Bus SA, Lange A. A comparison of the 1-step, 2-step, and 3-step protocols for obtaining barefoot plantar pressure data in the diabetic neuropathic foot. Clin Biomech. 2005; 20:892-9.
• [95]Malhotra S, Bello E, Kominsky S. Diabetic foot ulcerations: biomechanics, Charcot foot, and total contact cast. Semin Vasc Surg. 2012; 25:66-9.