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BMC Endocrine Disorders
Published in: BMC Endocrine Disorders 1/2015

Open Access 01-12-2015 | Study protocol

Lower limb biomechanical characteristics of patients with neuropathic diabetic foot ulcers: the diabetes foot ulcer study protocol

Authors: Malindu Eranga Fernando, Robert George Crowther, Margaret Cunningham, Peter Anthony Lazzarini, Kunwarjit Singh Sangla, Jonathan Golledge

Published in: BMC Endocrine Disorders | Issue 1/2015

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Abstract

Background

Foot ulceration is the main precursor to lower limb amputation in patients with type 2 diabetes worldwide. Biomechanical factors have been implicated in the development of foot ulceration; however the association of these factors to ulcer healing remains less clear. It may be hypothesised that abnormalities in temporal spatial parameters (stride to stride measurements), kinematics (joint movements), kinetics (forces on the lower limb) and plantar pressures (pressure placed on the foot during walking) contribute to foot ulcer healing. The primary aim of this study is to establish the biomechanical characteristics (temporal spatial parameters, kinematics, kinetics and plantar pressures) of patients with plantar neuropathic foot ulcers compared to controls without a history of foot ulcers. The secondary aim is to assess the same biomechanical characteristics in patients with foot ulcers and controls over-time to assess whether these characteristics remain the same or change throughout ulcer healing.

Methods/Design

The design is a case–control study nested in a six-month longitudinal study. Cases will be participants with active plantar neuropathic foot ulcers (DFU group). Controls will consist of patients with type 2 diabetes (DMC group) and healthy participants (HC group) with no history of foot ulceration. Standardised gait and plantar pressure protocols will be used to collect biomechanical data at baseline, three and six months. Descriptive variables and primary and secondary outcome variables will be compared between the three groups at baseline and follow-up.

Discussion

It is anticipated that the findings from this longitudinal study will provide important information regarding the biomechanical characteristic of type 2 diabetes patients with neuropathic foot ulcers. We hypothesise that people with foot ulcers will demonstrate a significantly compromised gait pattern (reduced temporal spatial parameters, kinematics and kinetics) at base line and then throughout the follow-up period compared to controls. The study may provide evidence for the design of gait-retraining, neuro-muscular conditioning and other approaches to off-load the limbs of those with foot ulcers in order to reduce the mechanical loading on the foot during gait and promote ulcer healing.
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Literature
1.
Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005;293(2):217–28.CrossRefPubMed
2.
Lazzarini PA, O’Rourke SR, Russell AW, Derhy PH, Kamp MC. Reduced incidence of foot-related hospitalisation and amputation amongst persons with diabetes in Queensland, Australia. PLoS ONE. 2015;10(6):e0130609.PubMedCentralCrossRefPubMed
3.
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(1):24.PubMedCentralCrossRefPubMed
4.
Boulton AJ, Krisner RS, Vileikyte L. Neuropathic diabetic foot ulcers. N Engl J Med. 2004;351:48–55.CrossRefPubMed
5.
Boulton AJM. The diabetic foot: from art to science. The 18th Camillo Golgi lecture. Diabetologia. 2004;47(8):1343–53.CrossRefPubMed
6.
Cavanagh PR, Simoneau GG, Ulbrecht JS. Ulceration, unsteadiness, and uncertainty: the biomechanical consequences of diabetes mellitus. J Biomech. 1993;26 Suppl 1:23–40.CrossRefPubMed
7.
Cavanagh PR, Ulbrecht JS. Clinical plantar pressure measurement in diabetes: rationale and methodology. Foot. 1994;4(3):123–35.CrossRef
8.
Katoulis EC, Boulton AJ, Raptis SA. The role of diabetic neuropathy and high plantar pressures in the pathogenesis of foot ulceration. Horm Metab Res. 1996;28(4):159–64.CrossRefPubMed
9.
Fernando ME, Crowther RG, Pappas E, Lazzarini PA, Cunningham M, Sangla KS, et al. Plantar pressure in diabetic peripheral neuropathy patients with active foot ulceration, previous ulceration and no history of ulceration: a meta-analysis of observational studies. PLoS ONE. 2014;9(6):e99050.PubMedCentralCrossRefPubMed
10.
Fernando M, Crowther R, Lazzarini P, Sangla K, Cunningham M, Buttner P, et al. Biomechanical characteristics of peripheral diabetic neuropathy: a systematic review and meta-analysis of findings from the gait cycle, muscle activity and dynamic barefoot plantar pressure. Clin Biomech (Bristol, Avon). 2013;28(8):831–45.CrossRef
11.
Formosa C, Gatt A, Chockalingam N. The importance of clinical biomechanical assessment of foot deformity and joint mobility in people living with type-2 diabetes within a primary care setting. Prim Care Diabetes. 2013;7(1):45–50.CrossRefPubMed
12.
Sartor CD, Watari R, Passaro AC, Picon AP, Hasue RH, Sacco IC. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2012;13(1):36.PubMedCentralCrossRefPubMed
13.
14.
Bacarin TA, Sacco IC, Hennig EM. Plantar pressure distribution patterns during gait in diabetic neuropathy patients with a history of foot ulcers. Clinics (Sao Paulo, Brazil). 2009;64(2):113–20.PubMedCentralCrossRef
15.
Savelberg HHCM, Schaper NC, Willems PJB, de Lange TLH, Meijer K. Redistribution of joint moments is associated with changed plantar pressure in diabetic polyneuropathy. BMC Musculoskelet Disord. 2009;10:16.PubMedCentralCrossRefPubMed
16.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–91.CrossRefPubMed
17.
Mancera-Romero J, Rodriguez-Morata A, Angel Sanchez-Chaparro M, Sanchez-Perez M, Paniagua-Gomez F, Hidalgo-Conde A, et al. Role of an intermittent claudication questionnaire for the diagnosis of PAD in ambulatory patients with type 2 diabetes. Int Angiol. 2013;32(5):512–7.PubMed
18.
19.
O’Rourke S, Steffen C, Raulli A, Tulip F. Diabetic major amputation in Far North Queensland 1998–2008: what is the Gap for Indigenous patients? Aust J Rural Health. 2013;21(5):268–73.CrossRefPubMed
20.
Hariri S, Yoon PW, Qureshi N, Valdez R, Scheuner MT, Khoury MJ. Family history of type 2 diabetes: a population-based screening tool for prevention? Genet Med. 2006;8(2):102–8.CrossRefPubMed
21.
Fowler MJ. Microvascular and macrovascular complications of diabetes. Clinical Diabetes. 2008;26(2):77–82.CrossRef
22.
Willi C, Bodenmann P, Ghali WA, Faris PD, Cornuz J. Active smoking and the risk of type 2 diabetes: a systematic review and meta-analysis. JAMA. 2007;298(22):2654–64.CrossRefPubMed
23.
Armstrong DG, Lavery LA, Holtz-Neiderer K, Mohler MJ, Wendel CS, Nixon BP, et al. Variability in activity may precede diabetic foot ulceration. Diabetes Care. 2004;27(8):1980–4.CrossRefPubMed
24.
Bus SA, Valk GD, van Deursen RW, Armstrong DG, Caravaggi C, Hlavacek P, et al. The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a systematic review. Diabetes Metab Res Rev. 2008;24 Suppl 1:S162–80.CrossRefPubMed
25.
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(7):1331–6.PubMedCentralCrossRefPubMed
26.
Mooradian AD. Dyslipidemia in type 2 diabetes mellitus. Nat Clin Pract End Met. 2009;5(3):150–9.CrossRef
27.
Harris EH. Elevated liver function tests in type 2 diabetes. Clin Diabetes. 2005;23(3):115–9.CrossRef
28.
Yentes JM, Sayles H, Meza J, Mannino DM, Rennard SI, Stergiou N. Walking abnormalities are associated with COPD: an investigation of the NHANES III dataset. Respir Med. 2011;105(1):80–7.CrossRefPubMed
29.
30.
Golledge J, van Bockxmeer F, Jamrozik K, McCann M, Norman PE. Association between serum lipoproteins and abdominal aortic aneurysm. Am J Cardiol. 2010;105(10):1480–4.CrossRefPubMed
31.
Johnson DW, Jones GR, Mathew TH, Ludlow MJ, Doogue MP, Jose MD, et al. Chronic kidney disease and automatic reporting of estimated glomerular filtration rate: new developments and revised recommendations. MJA. 2012;197(4):224–5.
32.
Golledge J, Ewels C, Muller R, Walker PJ. Association of chronic kidney disease categories defined with different formulae with major adverse events in patients with peripheral vascular disease. Atherosclerosis. 2014;232(2):289–97.CrossRefPubMed
33.
Jebb SA, Cole TJ, Doman D, Murgatroyd PR, Prentice AM. Evaluation of the novel Tanita body-fat analyser to measure body composition by comparison with a four-compartment model. Br J Nutr. 2000;83(2):115–22.CrossRefPubMed
34.
Klein S, Allison DB, Heymsfield SB, Kelley DE, Leibel RL, Nonas C, et al. Waist circumference and cardiometabolic risk: a consensus statement from Shaping America’s Health: Association for Weight Management and Obesity Prevention; NAASO, The Obesity Society; the American Society for Nutrition; and the American Diabetes Association. Am J Clin Nutr. 2007;85(5):1197–202.PubMed
35.
Esmaillzadeh A, Mirmiran P, Moeini SH, Azizi F. Larger hip circumference independently contributed to reduced metabolic risks in Tehranian adult women. Int J Cardiol. 2006;108(3):338–45.CrossRefPubMed
36.
37.
Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, et al. Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the subcommittee of professional and public education of the American Heart Association Council on high blood pressure research. Hypertension. 2005;45(1):142–61.CrossRefPubMed
38.
Wofford MR, Harkins KG, King DS, Habeeb GE, Wyatt SB, Jones DW. P-175: accurate cuff size in blood pressure measurement. Am J Hypertens. 2002;15(S3):92A.CrossRef
39.
Kruse I, Edelman S. Evaluation and treatment of diabetic foot ulcers. Clin Diabetes. 2006;24(2):91–3.CrossRef
40.
Stubbing NJ, Bailey P, Poole M. Protocol for accurate assessment of ABPI in patients with leg ulcers. J Wound Care. 1997;6(9):417–8.PubMed
41.
42.
Wood WA, Wood MA, Werter SA, Menn JJ, Hamilton SA, Jacoby R, et al. Testing for loss of protective sensation in patients with foot ulceration: a cross-sectional study. J Am Podiatr Med Assoc. 2005;95(5):469–74.CrossRefPubMed
43.
Thivolet C, el Farkh J, Petiot A, Simonet C, Tourniaire J. Measuring vibration sensations with graduated tuning fork. Simple and reliable means to detect diabetic patients at risk of neuropathic foot ulceration. Diabetes Care. 1990;13(10):1077–80.CrossRefPubMed
44.
Moghtaderi A, Bakhshipour A, Rashidi H. Validation of Michigan neuropathy screening instrument for diabetic peripheral neuropathy. Clin Neurol Neurosurg. 2006;108(5):477–81.CrossRefPubMed
45.
Hu H, Li H, Zheng FP, Cheng Y, Miao J, Zhang W. A comparison of clinical effectiveness of different neuropathy scoring systems in screening asymptomatic diabetic peripheral neuropathy. Zhonghua Nei Ke Za Zhi. 2012;51(1):13–7.PubMed
46.
Dyck PJ, Karnes J, O’Brien PC, Swanson CJ. Neuropathy symptom profile in health, motor neuron disease, diabetic neuropathy, and amyloidosis. Neurology. 1986;36(10):1300–8.CrossRefPubMed
47.
Perkins BA, Orszag A, Ngo M, Ng E, New P, Bril V. Prediction of incident diabetic neuropathy using the monofilament examination: a 4-year prospective study. Diabetes Care. 2010;33(7):1549–54.PubMedCentralCrossRefPubMed
48.
Feng Y, Schlösser FJ, Sumpio BE. The Semmes Weinstein monofilament examination as a screening tool for diabetic peripheral neuropathy. J Vasc Surg. 2009;50(3):675–82.CrossRefPubMed
49.
England JD, Gronseth GS, Franklin G, Miller RG, Asbury AK, Carter GT, et al. Distal symmetrical polyneuropathy: a definition for clinical research. A report of the American Academy of Neurology, the American Association of Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Arch Phys Med Rehabil. 2005;86(1):167–74.CrossRefPubMed
50.
Elveru RA, Rothstein JM, Lamb RL. Goniometric reliability in a clinical setting: Subtalar and ankle joint measurements. Phys Ther. 1988;68(5):672–7.PubMed
51.
Lázaro-Martínez J, Aragón-Sanchez F, Beneit-Montesinos J, González-Jurado M, Morales E, Hernández D. Foot biomechanics in patients with diabetes mellitus: doubts regarding the relationship between neuropathy, foot motion, and deformities. J Am Podiatr Med Assoc. 2011;101(3):208–14.CrossRefPubMed
52.
Fernando DJS, Masson EA, Veves A, Boulton AJM. Relationship of limited joint mobility to abnormal foot pressures and diabetic foot ulceration. Diabetes Care. 1991;14(1):8–11.CrossRefPubMed
53.
Paternostro-Sluga T, Grim-Stieger M, Posch M, Schuhfried O, Vacariu G, Mittermaier C, et al. Reliability and validity of the Medical Research Council (MRC) scale and a modified scale for testing muscle strength in patients with radial palsy. J Rehabil Med. 2008;40(8):665–71.CrossRefPubMed
54.
Menz HB, Fotoohabadi MR, Wee E, Spink MJ. Visual categorisation of the Arch Index: a simplified measure of foot posture in older people. J Foot Ankle Res. 2012;5 Suppl 1:15.CrossRef
55.
Bus SA, Maas M, de Lange A, Michels RPJ, Levi M. Elevated plantar pressures in neuropathic diabetic patients with claw/hammer toe deformity. J Biomech. 2005;38(9):1918–25.CrossRefPubMed
56.
Garrow AP, Papageorgiou A, Silman AJ, Thomas E, Jayson MI, Macfarlane GJ. The grading of hallux valgus. The Manchester Scale. J Am Podiatr Med Assoc. 2001;91(2):74–8.CrossRefPubMed
57.
Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound classification system- the contribution of depth, infection, and ischemia to risk of amputation. Diabetes Care. 1998;21(5):855–9.CrossRefPubMed
58.
Piaggesi A, Palumbo F, Tedeschi A, Ambrosini L, Macchiarini S, Scatena A, et al. Measurements in the diabetic foot. Wounds. 2005;17(9):247–54.
59.
Wu SC, Driver VR, Wrobel JS, Armstrong DG. Foot ulcers in the diabetic patient, prevention and treatment. Vasc Health Risk Manag. 2007;3(1):65–76.PubMedCentralPubMed
60.
Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG, et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54(12):1679–84.CrossRefPubMed
61.
Apelqvist J. The foot in perspective. Diabetes Metab Res Rev. 2008;24 Suppl 1:110–5.CrossRef
62.
Nelson EA, O’Meara S, Craig D, Iglesias C, Golder S, Dalton J, et al. A series of systematic reviews to inform a decision analysis for sampling and treating infected diabetic foot ulcers. Health Technol Assess. 2006;10(12):3. –4, 9–10, 1–221.CrossRef
63.
64.
Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG, et al. Executive summary: 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54(12):1679–84.CrossRefPubMed
65.
Armstrong DG, Lavery LA. Evidence-based options for off-loading diabetic wounds. Clin Podiatr Med Surg. 1998;15(1):95–104.PubMed
66.
Frykberg RG. Diabetic foot ulcers: pathogenesis and management. Am Fam Physician. 2002;66(9):1655–62.PubMed
67.
Davis RB, Ounpuu S, Tyburski D, Gage JR. A gait analysis data collection and reduction technique. Hum Mov Sci. 1991;10:575–87.CrossRef
68.
Whittle J. Whittle’s Gait Analysis. 5th ed. China: Elsevier; 2012.
69.
Eshraghi A, Abu Osman NA, Karimi M, Gholizadeh H, Soodmand E, Abas WABW. Gait biomechanics of individuals with transtibial amputation: effect of suspension system. PLoS ONE. 2014;9(5):e96988.PubMedCentralCrossRefPubMed
70.
Raspovic A. Gait characteristics of people with diabetes-related peripheral neuropathy, with and without a history of ulceration. Gait Posture. 2013;38(4):723–8.CrossRefPubMed
71.
72.
Qiu X, Tian DH, Han CL, Chen W, Wang ZJ, Mu ZY, et al. Risk Factors Correlated with Plantar Pressure in Chinese Patients with Type 2 Diabetes. Diabetes Technol Ther. 2013;15:1025–32.CrossRefPubMed
73.
Peters EJ, Urukalo A, Fleischli JG, Lavery LA. Reproducibility of gait analysis variables: one-step versus three-step method of data acquisition. J Foot Ankle Surg. 2002;41(4):206–12.CrossRefPubMed
74.
Wolfson L. Gait and balance dysfunction: a model of the interaction of age and disease. Neuroscientist. 2001;7(2):178–83.
75.
Ludbrook J. Multiple comparison procedures updated. Clin Exp Pharmacol Physiol. 1998;25(12):1032–7.
76.
Knudson D. Significant and meaningful effects in sports biomechanics research. Sports Biomech. 2009;8(1):96–104.
Metadata
Title
Lower limb biomechanical characteristics of patients with neuropathic diabetic foot ulcers: the diabetes foot ulcer study protocol
Authors
Malindu Eranga Fernando
Robert George Crowther
Margaret Cunningham
Peter Anthony Lazzarini
Kunwarjit Singh Sangla
Jonathan Golledge
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Endocrine Disorders / Issue 1/2015
Electronic ISSN: 1472-6823
DOI
https://doi.org/10.1186/s12902-015-0057-7

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