Risk factors of diabetic foot ulcer in patients attending diabetic foot outpatient clinic at Tanta University Hospital in Egypt

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1 he Journal of Diabetic Foot Complications Risk factors of diabetic foot ulcer in patients attending diabetic foot outpatient clinic at anta University Hospital in Egypt Authors: Ghada Al-Ghazaly, MD* Loai Al-Ahwal, MD Khaled Zagloul, MD he Journal of Diabetic Foot Complications, 2015; Volume 7, Issue 2, No. 3, ages All rights reserved. Abstract: Foot ulceration is one of the most serious and disabling complications of diabetes mellitus (DM). It is the most common cause of non-traumatic foot amputation worldwide. his study aimed to determine the prevalence of diabetic foot ulcers (DFU) in a group of diabetic patients and to describe the risk factors associated with this disease in the studied patients. he study included 300 diabetic patients, with different disease durations. A complete history was taken, and fasting, post-prandial glucose, HbA1c, serum cholesterol, and Doppler ultrasound for assessment of ankle-brachial index (ABI) were performed at baseline. he data was analyzed using the statistical package SSS. Eighty eight patients (29.3%) were found to have foot ulcer disease; 198 out of the 300 patients (63.3%) had vascular complications, and neuropathy was reported in 264 patients (88.0%). In this study, 88 patients (29.3%) were found to have foot ulcer disease. Uncontrolled hyperglycemia and prolonged disease duration were the most important risk factors for DFU and were associated with a worse prognosis. Key words: Diabetic Foot Ulcer, Neuropathy, Risk Factors, Vascular Complications Corresponding author * Ghada Al-Ghazaly, MD Internal Medicine Department Faculty of Medicine anta University, Egypt dodoya288@yahoo.com Affiliations From the Internal Medicine Department Faculty of Medicine anta University Egypt INRODUCION Diabetes mellitus (DM) is a group of metabolic diseases in which a person has high blood glucose. Recent estimates indicate that there were 171 million people in the world with diabetes in the year 2000, and this is projected to increase to 366 million by ,2 It is associated with reduced life expectancy, significant morbidity due to specific diabetes related microvascular complications, increased risk of macrovascular complications (ie, ischemic heart disease, stroke, and peripheral vascular disease), and diminished quality of life. 3 One of the most common complications of diabetes in the lower extremity is the diabetic foot ulcer (DFU). An estimated 15% of patients with diabetes will develop a lower extremity ulcer during the course of their disease. 4 Diabetic neuropathy is the impact of diabetes on the nervous system, most commonly causing numbness, tingling, and pain in the feet and also increasing the risk of skin damage due to altered sensation. ogether with vascular disease in the legs, neuropathy contributes to the risk of diabetes-related foot problems such as DFUs that can be difficult to treat and occasionally require amputation. 2,3 he common initial lesion leading to amputation is a non-healing skin ulcer, induced by regional pressure, pathogenically linked to sensory neuropathy, ischemia, and infection. 5 Diabetic foot complication is usually the result of the interplay of these varied causative factors, of`which neuropathy is considered to be the most important. 6 Diabetic neuropathy is present to some degree in >50% of patients who are older than 42

2 he Journal of Diabetic Foot Complications, 2015; Volume 7, Issue 2, No. 3, ages years of age. It increases the risk of foot ulceration by seven fold. 6,7,8 Diabetes accounts for up to 80% of non-traumatic amputations, with 85% of these being preceded by a foot ulcer. 9 Foot disorders are a major source of morbidity and a leading cause of hospitalization for persons with diabetes. Ulceration, infection, gangrene, and amputation are significant complications of the disease, estimated to cost billions of dollars each year. Charcot foot, which of itself can lead to limb-threatening disorders, is another serious complication of long-standing diabetes. Amputation carries with it a significantly elevated mortality at follow-up, ranging from 13% to 40% at one year to 39 80% at five years. 10 herefore, this study aimed to determine the prevalence of DFUs in a group of diabetic patients and to describe the risk factors associated with this disease. AIENS AND MEHODS his study included 300 patients at the Diabetes and Endocrinology Outpatient Clinic, Internal Medicine Department, anta University Hospital, from August 2012 through December atients were informed about the study and signed a consent form. hey were divided into the following three groups, excluding those with neuropathy of non-diabetic etiology, and ulcer or amputation of non-diabetic etiology. Group I: atients with ype 2 diabetes for less than five years. Group II: atients with ype 2 diabetes for between five to ten years. Group III: atients with ype 2 diabetes for more than ten years. All patients provided medical, general, and wound and ulcer histories. atient exams included a vascular examination (ie, peripheral pulse, ABI), a gait evaluation, an assessment of foot wear or type of shoes, a determination of depth of toes boxes, a dermatological examination, a neurological examination, a musculoskeletal examination, and a biomechanical examination in the form of limited mobility and previous amputation. When present, ulcers were characterized by base, presence or absence of granulations, size, color, vascularity, depressed or elevated, composition and odor, and surrounding tissue type (ie, congested, edematous, inflamed or indurated). Laboratory investigations include fasting, post-prandial blood glucose, HbA1c, lipids, serum cholesterol, and ABI by Doppler ultrasound. For an ABI examination Doppler ultrasound blood flow detector and a sphygmomanometer (ie, blood pressure cuff) are usually needed. he blood pressure cuff is inflated proximal to the artery in question. Measured by the Doppler probe, the inflation continues until the pulse in the artery ceases. he blood pressure cuff is then slowly deflated. When the artery's pulse is redetected through the Doppler probe, the pressure in the cuff at that moment indicates the systolic pressure of that artery. Where Leg is the systolic blood pressure of dorsalis pedis or posterior tibial arteriesand Arm is the highest of the left and right arm brachial systolic blood pressure. he higher systolic reading of the left and right arm brachial artery is generally used in the assessment. he pressures in each foot's posterior tibial artery and dorsalis pedis artery are measured, with the higher of the two values used as the Ankle-Brachial pressure index (ABI) for that leg. he ABI test is a popular tool for the noninvasive assessment of peripheral vascular disease (VD). Studies have shown the sensitivity of ABI is 90% with a corresponding 98% specificity for detecting hemodynamically significant (serious) stenosis >50% in major leg arteries, defined by angiogram. 11 INERREAIONS OF RESULS In a normal subject the ankle pressure is slightly higher than at the elbow. here is reflection of the pulse pressure from the vascular bed of the feet; whereas at the elbow, the artery 43

3 he Journal of Diabetic Foot Complications, 2015; Volume 7, Issue 2, No. 3, ages continues on some distance to the wrist. he ABI is the ratio of the highest ankle to brachial artery pressure. An ABI between 0.9 and 1.2 is considered normal (ie, free from significant peripheral arterial disease (AD)) while less than 0.9 indicates arterial disease. An ABI value greater than 1.3 is also considered abnormal, and suggests calcification of the walls of the arteries and incompressible vessels. While this can occur in normally perfused feet, it can also occur in those with severe peripheral vascular disease. In the latter case, this false elevation of arterial pressures can make diagnosis of AD a challenge. rovided that there are no other significant conditions affecting the arteries of the leg, the ABI ratios in able 1 can be used to predict the severity of AD, as well as to assess the nature and best management of various types of leg ulcers. able 1. ABI values, action, and nature of ulcers, if present. ABI Value Above 1.2 Interpretation Abnormal vessel hardening from VD Normal range Acceptable Under 0.5 Some arterial disease Moderate arterial disease Severe arterial disease 10-g MONOFILAMENS Action Refer routinely None Manage risk factors Routine specialist referral Urgent specialist referral Nature of, if resent Venous ulcer: use full compression bandaging Mixed ulcers: use reduced compression bandaging Arterial ulcers: no compression bandaging Nylon monofilaments are constructed to buckle when a 10-g force is applied. Loss of the ability to detect this pressure at one or more anatomic sites on the plantar surface of the foot has been associated with loss of large-fiber nerve function. It is recommended that four sites (ie, 1st, 3rd, and 5th metatarsal heads and plantar surface of distal hallux) be tested on each foot. Caution is necessary when selecting the brand of monofilament to use, as many commercially available monofilaments have been shown to be inaccurate. Single-use disposable monofilaments are the most suitable. he sensation of pressure using the buckling 10-g monofilament should first be demonstrated to the patient on a proximal site (ie, upper arm). he sites of the foot may then be examined by asking the patient to respond yes or no when asked whether the monofilament is being applied to the particular site. he patient should recognize the perception of pressure, as well as identify the correct site. Areas of callus should always be avoided when testing for pressure perception HZ UNING FORKS Vibratory sensation should be tested over the tip of the great toe bilaterally. An abnormal response can be defined as when the patient loses vibratory sensation and the examiner still perceives it while holding the fork on the tip of the toe. INRICK SENSAION Similarly, the inability of a subject to perceive pinprick sensation has been associated with an increased risk of ulceration. A disposable pin should be applied just proximal to the toenail on the dorsal surface of the hallux, with just enough pressure to deform the skin. Inability to perceive pinprick over either hallux would be regarded as an abnormal test result. ANKLE REFLEXES Absence of ankle reflexes has also been associated with increased risk of foot ulceration. Ankle reflexes can be tested with the patient either kneeling or resting on a couch/table. he Achilles tendon should be stretched until the ankle is in a neutral position before striking it with the tendon hammer. If a response is initially absent, the patient can be asked to hook fingers together and pull, with the ankle reflexes then retested with reinforcement. otal absence of ankle reflex either at rest or upon reinforcement is regarded as an abnormal result. 44

4 he Journal of Diabetic Foot Complications, 2015; Volume 7, Issue 2, No. 3, ages RESULS Results are displayed in ables 2-9 and are presented below. able 3. Disease duration in the studied patients (n=300). Disease Duration Range: Mean ± SD 9.8 ± 6.1 Number % 5 years able 2. Clinical findings in the studied patients (n=300). Smoking Variant resent or Not Number % eripheral pulse Skin emperature sensitivity resence of hair Edema Varicose veins Numbness Burning pain Sensitivity to touch Muscle cramps Weakness revious amputation in prick test Ankle reflex Friable tissue Nail dystrophy Callus eeling or maceration positive negative Intact Absent Normal Abnormal Absent Normal resent Absent resent Absent resent Absent resent Absent resent Good oor Absent resent Absent resent Absent resent Good oor Good oor Absent resent Absent resent Absent resent Absent resent years >10 years able 4. Laboratory findings in the studied patients (n=300). Laboratory Range Mean ± SD Fasting BG ± 85.0 ostprandial BG ± HbA1c (%) ± 1.1 Serum cholesterol ± 38.1 able 5. revalence of DFU in the studied patients (n=300). Foot Ulcer Number ercent resent Absent able 6. Comparison between patients with DFU and patients without regarding the demographic characteristics. Foot n=88 No Foot n=212 Age 54.9 ± ± BMI 27.4 ± ± Gender Male 64 (72.7 %) 128 (60.4 %) Female 24 (27.3 %) 84 (39.6) * statistically significant able 6 shows that patients with a DFU had statistically significant higher frequency in male gender when compared with patients without. able 7 shows that patients with DFU had significantly longer disease duration when compared with patients without. Chi-square test X * 45

5 he Journal of Diabetic Foot Complications, 2015; Volume 7, Issue 2, No. 3, ages able 8 shows that patients with foot ulcer had statistically significant higher HbA1c levels when compared with patients without. able 9 shows that patients with neuropathy had significantly longer disease duration when compared with patients without. able 7. Comparison between patients with DFU and patients without regarding the disease duration. Foot n=88 No Foot n=212 Disease duration 11.2 ± ± years years > 10 years * statistically significant able 8. Comparison between patients with DFU and patients without regarding the laboratory findings. he Foot n=88 No Foot n=212 Chi-square test X * Fasting BG ± ± ostprandial BG ± ± HbA1c 7.6 ± ± * Serum cholesterol ± ± able 9. Comparison between patients with neuropathy and patients without regarding the disease duration. Disease duration Neuropathy (n=264) No Neuropathy (n= 36) 12.4 ± ± * 5 years years > 10 years Chi-square test X * DISCUSSION Diabetes continues to be the most common underlying cause of non-traumatic lower extremity amputations (LEAs) in the US and Europe. 12 he prevalence of DFU ranges from 4% to 10% in hospitalized patients. he risk of developing a foot ulcer in diabetic patients could be as high as 25% in their lifetime. 13 Nearly 14% 24% of patients with DFU require amputation, which means that every thirty seconds a lower limb is lost because of diabetes. he Global Lower Extremity Amputation Study Group estimated that 25% 90% of all amputations were associated with diabetes. 14 In the present study, 88 patients (29.3 %) were found to have foot ulcer disease. his figure is close to what found by Mansour and Dahyak (2008), 15 who estimated the prevalence of foot abnormalities among Iraqis with diabetes, and found that 27.0% of the studied diabetic patients had foot ulcers. Also, in the study of Moura Neto et al., (2013) 16 the prevalence of DFU in the studied patients was 25.3%. When comparing patients with DFU and patients without DFU regarding the demographic characteristics we found that patients with DFU had statistically significant higher frequency in males when compared with patients without. his is in accordance with the study of Hokkam (2009) 17 who aimed to identify risk factors for DFU and their impact on the outcome of the disease. In their study, male gender was a significant risk factor for the development of foot ulcer disease in diabetic patients. It is possible to suggest that males are more liable to foot trauma, and hence they are more prone to have diabetic foot ulceration. 18 Regarding the relation between DFU and diabetes duration, the present study showed that patients with DFU had significantly longer disease duration when compared with patients without. his is consistent with the results of Boyko et al., (2006) who conducted a prospective study to discover the factors predictive of foot ulcer occurrence. In their study, patients with * statistically significant 46

6 he Journal of Diabetic Foot Complications, 2015; Volume 7, Issue 2, No. 3, ages foot ulcer disease had a statistically significant higher duration of diabetes when compared with patients without. 19 Comparison of laboratory findings between patients with DFU and patients without shows that foot ulcer patients had significantly higher HbA1c when compared with patients without. his suggests a poorer glycemic control in patients with foot ulcer. his is consistent with Boyko who also found a significant association between glycemic control as expressed by HbA1c and the occurrence of DFU. 19 Regarding the frequency of diabetic neuropathy in the studied patients, the present study found that neuropathy was reported in 264 of the 300 patients (88.0 %). Also, those with neuropathy had significantly longer disease duration when compared with patients without. his is consistent with the study of Ibarra et al., (2012) who aimed to determine the prevalence of diabetic peripheral neuropathy in ype 2 diabetic patients in a family medicine unit and found an increasing prevalence of neuropathy with increasing diabetes duration. 20 Vascular disease is a common problem in patients with long-standing diabetes. he present study found that 190 out of 300 patients (63.3%) had vascular complications. Also, it was found that patients with vasculopathy had significantly longer disease duration when compared with patients without. his is similar to the study of Zhang et al., (2002) who found a prevalence of coronary heart disease of 25.1%, cerebral vascular disease 17.3%, and vessel complications of the lower limbs in 9.3% of their patients. 21 In addition, the present study found that patients with vasculopathy had statistically significant higher fasting and postprandial glucose levels when compared with patients without. his is in line with the conclusions of Xu et al., (2005) that hyperglycemia is a significant and independent risk factor for the vascular complications in patients with diabetes. 22 In conclusion, 88 patients (29.3 %) were found to have foot ulcer disease. Male gender, uncontrolled hyperglycemia, and prolonged disease duration were the most important risk factors of DFU in this study. References 1. Chauchard MC, Cousty-ech F, Martini J, et al. 2001: Le pied diabétique. La revue du praticien. 2001;51: Armstrong DG, Lavery LA. Diabetic foot ulcers; prevention, diagnosis and classification. J foot Ankle Surg. 1996;35: Inlow S, Orsted H, Sibbald RG. Best practices for the prevention, diagnosis, and treatment of diabetic foot ulcers. Ostomy Wound Manage. 2001;52: Reiber GE. Epidemiology of foot ulcers and amputations in the diabetic foot. he Diabetic Foot. 2001; Reed JF 3rd.An audit of lower extremity complications in octogenarian patients with diabetes mellitus. Int J Low Extrem Wounds. 2004;3(3): Reiber GE, Vileikyte L, Boyko EJ, et al. Lavery LA, Boulton AJ. Causal pathways for incident lower extremity ulcers in patients with diabetes from two settings. Diabetes Care. 1996;22: Young MJ, Boulton AJ, MacLeod AF, et al. A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologia. 1993;36: Young MJ, Breddy JL, Veves A, et al. he prediction of diabetic neuropathic foot ulceration using vibration perception thresholds. A prospective study. Diabetes Care. 1994;17: rautner C, Haastert B, Giani G, et al. Incidence of lower limb amputations and diabetes. Diabetes Care. 1996;19: Singh N, Armstrong DG, Lipsky BA. reventing foot ulcers in patientswith diabetes. JAMA. 2005;1: Urbancic-Rovan V. Causes of diabetic foot lesions. Lancet. 2005;366:

7 he Journal of Diabetic Foot Complications, 2015; Volume 7, Issue 2, No. 3, ages Jeffcoate WJ. he incidence of amputation in diabetes. Acta Chir Belg. 2005;105: Norris SL, Nichols J, Caspersen CJ, et al. Increasing Diabetes Self-Management Education in Community Settings. A Systematic Review. Am J rev Med. 2002;22(4): Oyibo SO, Jude EB, arawneh I, et al. A comparison of two diabetic foot ulcer classification systems: the Wagner and the University of exas wound classification systems. Diabetes Care. 2001;24(1): Mansour AA.Dahyak SG. Foot abnormalities among adults. Are they are more common in diabetics? A Cross sectional study in Basrah, Iraq. he ermanente Journal. 2008;12(4): Moura Neto A, Zantut-Wittmann DE, Fernandes D, et al. Risk factors for ulceration and amputation in diabetic foot: study in a cohort of 496 patients. Endocrine. 2013;44(1): Hokkam EN. Assessment of risk factors in diabetic foot ulceration and their impact on the outcome of the disease. rim Care Diabetes. 2009;3(4): McDermott MM, Criqui MH, Liu K, et al. Lower ankle/brachial index, as calculated by averaging the dorsalis pedis and posterior tibial arterial pressures, and association with leg functioning in peripheral arterial disease. JJ Vasc Surg. 2000;32(6): Boyko EJ, Ahroni JH, Cohen V, et al. rediction of Diabetic Foot Ulcer Occurrence Using Commonly Available Clinical Information. Diabetes Care. 2006;29: Ibarra C, Rocha Jde J, Hernández RO, et al. revalence of peripheral neuropathy among primary care type 2 diabetic patients. Rev Med Chil. 2012;140(9): Zhang B, Xiang HD, Mao WB, et al. Epidemiological survey of chronic vascular complications of type 2 diabetic in-patients in four municipalities. Zhongguo Yi Xue Ke Xue Yuan Xue Bao, 2002;24(5): Xu Y, He Z. King GL. Introduction of hyperglycemia and dyslipidemia in the pathogenesis of diabetic vascular complications. Curr Diab Rep. 2005;5(2):