Manal Ghazzawi,Joseph Sam Kanu,and Patrick O Erah

Abstract—Introduction:Diabetes Mellitus is a global health issue,though current prevalence data is lacking Sierra Leone has an increasing number of diagnosed and undiagnosed diabetes.Lack of education and self-care,poor adoption ofhealthy lifestyle may be the main factors leading to an increased risk of diabetic foot ulcers.Objectives:To identify patients with diabetes at risk of developing foot ulcers,diabetic neuropathy,peripheral artery disease and to investigate the association between independent risk factors involved in development of foot ulcers and other clinically related factors. Methods: Study was done at two sites,Connaught hospital and a clinic in Freetown.A standardized questionnaire was administered for risk assessment of diabetic ulcers.A total of 231 participants(Ages 45-75 years)were recruited via systematic random sampling.Descriptive statistics was used to analyze data using SPSS.Results: Majority of participants (64.5%) were diagnosed with diabetes within 1-5 years,5.5% and 13.4% had eye and kidney disease respectively.Protective sensation evaluation revealed that 38.5% had loss of protective sensation and 19% had suspected peripheral arterial disease with absent pulse at the posterior tibial artery and dorsalis pedis.Age,occupation,years since diagnosis and type of diabetes was significantly associated with high risk of developing diabetic foot ulcers with a P value ＜ 0.005.Risk Categorization of participants revealed 76% at low risk while those at moderate,high and highest risks were 20%,17% and 3.5%respectively.Individuals with prior kidney disease,eye problems and previous history of amputation had greater loss of protective sensation,absent pulse,and tingling sensation at extremities.Conclusion: There’s great need for health care workers to become diabetes educators to offer proper services like diabetes foot examination to prevent diabetes ulcers which leads to amputation.Detecting diabetic patients at risk for diabetic foot ulcers will go a long way to prevent future amputations and other associated complications.

Keywords:Diabetes Mellitus,Peripheral Arterial Disease,Loss of Protective Sensation,Diabetic Foot Ulcers

I.INTRODUCTION

Diabetes mellitus results in increased health burden or cost;increased mortality due to its life-threatening complications[1].Continuous increase in blood glucose levels leading to generalized vascular damage which in turn affects the kidney,and eyes and subsequently other complications [2].In a systematic review and meta-analysis,global prevalence of diabetic foot is 6.3% and that of Africa is 7.2%[3].In developing countries,diabetic foot ulcers (DFU) are a major cause of disability,morbidity,and mortality among diabetic patients,and it has been estimated that 15%of all people with diabetes will have an ulcer at some stage of their life[4].In Sierra Leone though studies have not been done to justify this,there is a huge number of diagnosed and undiagnosed diabetes mellitus.Among other factors,poor access to health care,low income of individuals,lack of education about diabetes and its consequences,and lack of trained health personnel are among the main reasons associated with this.Hence,Lowincome countries like Sierra Leone or sub-Saharan Africa are projected to experience the largest burden of the disease by 2030 compared to developed countries [5].

Diabetic Neuropathy (DN) is the first or most common complication of DM and it’s the most common cause of limb amputations [6].Diabetic peripheral neuropathy (DPN) is generally associated with age,duration of diabetes,male gender,alcohol intake,glycaemic control or smoking [7].From a study done in 2014-2016 at the 34,military hospital[8],21 amputations have occurred as a result of diabetic foot.Research reveals that diabetic foot ulcer (DFU) is affected by several factors including patient’s age,educational status,BMI,type of diabetes mellitus,patient habits of foot selfcare practice,and the presence of complicated peripheral neuropathy [9,10,11,12].Poverty and unhygienic conditions may be associated with foot ulceration [13].Many people in Sierra Leone like to walk barefoot at home or wear unprotected foot wears that predisposes them to foot ulcers in the street.Patients who do not have access to ongoing foot care,advice,or education are most at risk of developing infected foot ulcers generally not available at regional,district or primary health care centre[14].This is typically the case in Sierra Leone,hardly health care workers are engaged in diabetes foot examination for their patients.

Screening for diabetic ulcers or DPN is very important to prevent future foot ulcers.It involves using simple screening equipments and techniques like detection of foot ulcers,anklebrachial pressure index (ABPI) to detect PAD,the use of 10g monofilament,tuning fork or biothesiometer for detecting problems with protective sensation.In addition,according to Best Practice Recommendations for The Prevention And Management of DFUs[15],comprehensive patient assessment to identify factors that may impact skin integrity and wound healing should include history and current health status (physical and emotional),head-to-toe skin assessment,wound assessment(if applicable),investigation of environmental factors such as socio-economic,cultural,care setting and access to services,and system factors such as government policies,support and program.Diabetes clinics are scarce in Sierra Leone,only few existin Freetown and hardly any in the provinces.Comprehensive foot assessment is hardly done anywhere to prevent DFUs,and most health care professionals lack the skills to do so.

This study investigatespatients at risk of developingdiabetic foot ulcers and its associated risk factors at Connaught Hospital and a clinic in the Western part of Freetown.Approximately 85% of amputations are preceded by the development of a neuropathic foot ulcer[16].Hence,identifying people at high risk of developing foot ulcers and offering advice during conduction of research can go a long way in preventing leg amputations.This study could also serve as a preliminary research to investigate further the impact of the adoption of comprehensive foot assessment in the prevention of DFUs as an interventional study.

II.METHODS

Cross sectional prospective design was used where patients that walk into the two facilities were selected by systematic random sampling technique.About 50-60 patients from various parts of Freetown that could not afford a glucometer visit the clinic every Wednesday.Eligible subjects who consented to participate in the study that visit the two clinics for follow up clinical evaluation were selected randomly.Sample size was determined based on the duration of the study which is three monthsi.e.from July to September 2019.Hence,study subjects were consecutively enrolled by systematic sampling technique,until a desired sample size of 231 participants was attained.

Semmes Weinstein Monofilament Test for light touch sensation and 128Hz tuning fork to assess vibration sense.A well-structured informed consent form and questionnaire are also included as study instruments.The questionnaire included demographic details and social and medical history including glucose monitoring,diabetes duration,type of diabetes,foot deformity,neuropathy symptoms,vascular symptoms,history of foot ulcer,history of retinopathy and nephropathy etc.was to be completed by all patients.The questionnaire had a separate section which had to be filled by the investigator because it involved physical and visual inspection of the leg and feet.Visual inspections like presence of skin change,structural deformities,fungal toenails and physical inspection like temperature of leg were to be recorded.Clinical assessment or screening for protective sensation (peripheral neuropathy)and peripheral arterial disease was also inclusive.Trained investigators were advised to do a pretest by administering the questionnaire on few patients who consented to undertake the study.From this pretest we were able to evaluate the questionnaire and to detect any errors or areas that needed more clarification.

Trained nurses applied the following instructions in conducting the diabetes foot examination:

1.They touched the monofilament to the patient’s arm or hand(avoid the hand if the person with diabetes has glove and stocking neuropathy) so they understand what to expect when monofilament testing is performed on the foot.

2.Before they touched the monofilament on patient’s foot,the patients were told to close their eyes and then instructed to say“yes”when they felt the sensation of the monofilament on their foot.

3.The monofilament was placed perpendicular to the foot and touched the skin only once,until the monofilament bends into a C-shape.The monofilament was not supposed to be applied over ulcer,callus,scar or necrotic tissue.

4.About 4 sights were tested sites as indicated in the diagram(Figure 3).

5.Response was then recorded on the questionnaire with“+”for yes and“-“for no.

6.If the monofilament was not felt in an area on the foot,this indicates loss of protective sensation (LOPS) in that area.

Use of Tuning Fork

1.Patients were asked to close their eyes.

2.The investigator thentaped the 128 Hz tuning fork.

3.The tuning fork was then placed onto the patient’s sternum and confirm the patient can feel it buzzing.

4.Patients were then asked to tell when they felt the vibration on their foot and to tell when it stopped buzzing.

5.Sensation was then assessed by placing the vibrating tuning fork onto the distal phalanx of the great toe.

6.If sensation was intact,the patient should state that they felt the tuning fork buzzing.

7.The investigator then gently placed his hand onto the tuning fork to stop it vibrating.If the patient’s sensation was intact,they should be able to recognize when the vibration has stopped.

8.If sensation was impaired,assessment was continued more proximally(e.g.proximal phalanx)

9.The assessment was then repeated on the other foot.

Data collected were entered using EPI-INFO version 3.5.3 and exported to SPSS statistical version 20 software for further analysis.Descriptive statistics were carried out to characterize the study population using different variables.Chi-square test was used to relate risk of diabetic neuropathy to that of socio-demographic and clinically related variables.Where appropriate cross tabulation was used to investigate the association between different independent variables like age,years since diagnosis,exercise,eye and kidney disease to that of other dependent variables like pulse at extremity and LOPS.Risk categorization (Low,moderate,high,highest risk) was analyzed using descriptive statistics.A variable with a p value of ＜0.05 was considered statistically significant.

Risk stratification was done using the IDF guidelines 2017on diabetic foot and PAD,hence patients found at risk of developing diabetic foot ulcers were classified based on standardized clinical related symptoms.Low risk:normal plantar sensation;Moderate risk:Loss of Protective Sensation with either High Pressure or Poor Circulation (PAD) or Structural Foot Deformities or Onychomycosis;High risk:history of ulceration,amputation or neuropathic Fracture

III.RESULTS

More females participated in the study 134 (58%) than males 97 (42%),more diabetics 88 (31.8%) at age ranges of 55-65 years were in the study,while age ranges of 45-55 and 65-75 were 69 (29.9%) and 73 (36.1%) respectively.Only 26(11.3%)smoked and only 29(12.6%)drink alcohol.Those that were physically inactive was 38(16.5%).Frequency of following a healthy diet was assessed where 128 (55.4%)sometimes follow a healthy diet while only 1(0.4%) follows no diet plan at all.

Majority of subjects had diagnosed type 2 diabetes while only 21 (9.1%) had type 1 diabetes.Many participants 149(64.5%)were diagnosed within 1-5 years and 24.2%within 6-10 years,9.5% diagnosed within 11-15 years.Assessing frequency of monitoring blood glucose levels reveals that 119(51.5%) monitor their blood sugar every week,69 (29.9%)every month,40 (17.3%) does every day and only 3(1.3%)does more than once per month.Assessment of previously diagnosed diabetic eye problems showed 82 (35.5%) had eye problems.Among those with kidney disease were of the minority 31 (13.4%).Foot structural deformity evaluation(either prominent metatarsal heads,hammertoe,high medial arch,nail changes,dermopathy) reveals that 64(27.7%) had structural deformity.Subjects with previous foot ulcer was 35(15.2%).Previous history of amputation depicts that only 9(3.9%) had an amputation in the past.Toe infection assessment shows that 27(11.7%) diabetics had fungal toenail.

Table 1demonstrates clearly different parameters involved in assessment of diabetics at risk of developing DN and PAD.Protective sensation evaluation reveals that 42(18.2%) lack vibration sense and 47(20.3%) had loss of sensation in more than one site.During assessment for PAD 44(19%) had no pulse in the Posterior Tibial Artery (PTA) and Dorsalis Pedis(DP).

Table 1:Assessment for Diabetic Neuropathy(DN)and Peripheral Arterial Disease(PAD)

Most common symptoms reported by participants in lower extremities were hot sensation 86(37.2%),tingling sensation 67(29%) and foot pain 44(19.0%).Among skin changes detected,dried skin was the most common together with edema 35(15.2%),only 13(5.6%) and 12(5.2%) similarly had fungal infection and corn respectively.

Table 2below revealed that age,occupation,years since diagnosis and type of diabetes was significantly associated with high risk of developing diabetic footulcers with a P value ＜ 0.005.Below depicts risk categorization for diabetic ulcers ac-cording to IDF 2017 diabetic foot clinical practice guidelines.Participants at low risk were 76% while those at moderate,high and highest risks were 20%,17%and 3.5%respectively.

Table 2:Chi square for risk of DN and socio-demographic and clinically related variables

Table 3Below depicts risk categorization for diabetic ulcers according to IDF 2017 diabetic foot clinical practice guidelines.Participants at low risk were 76%while those at moderate,high and highest risks were 20%,17% and 3.5%respectively.

Table 3:＊Risk Stratification for Participants at Risk of Developing Diabetic Foot Ulcers

Participants of older age (65-75 years) had greater LOPS(37%)at more than 2 sites compared to lower age groups,older age was also associated with greater absent pulse andvibration sense.Subjects smoke and drink alcohol had associated LOPS,absence of pulse,and symptoms of DN

LOPS among those that were physically active was 13%compared to those that were not physically active which had approx.58% of LOPS.Participants that are also physically inactive had greater absent pulse 58%.Subjects diagnosed of diabetes 11-15 years ago had the greatest LOPS(86.40%).Individuals with prior kidney disease had greater LOPS (80.6%) and absence of pulse (80.6%).Those with eye problems had more LOPS (39%) using the monofilament and 35.4% using the tuning fork.Eye problem was also associated with greater pulse absence (37.8%) and tingling sensation (34%).Adults with previous history of amputation had greater LOPS(78%),absent pulse (78%)together with greater tingling sensation symptoms.

IV.DISCUSSION

Majority of participants (91%) in this study had type 2 diabetes since it is the most common type of diabetes.DPN of the foot leads to loss of protective sensation (LOPS) doubling the likelihood of developing a foot ulcer and tripling the risk of a lower extremity amputation (LEA) [17].The increased risk of developing diabetic foot ulcers(DFU)can be accounted for in terms of patient’s age,physical inactivity,longer years since diagnosis,previous history of amputation,kidney and eye disease.These findings are in line with other studies which shows that many of the predisposing factors for DFU are well established and include advancing age,long duration of diabetes,poor glycemic control,presence of neuropathy and peripheral vascular disease[18].For example,previous report indicates that a person with diabetes has a 25% lifetime risk of developing DFU[19].In Sierra Leone and other parts of Africa,the prevalence of DFUs is expected to continue to rise because of poor health resources and infrastructure.Diabetes foot examination is hardly done as a routine check among diabetic patients in these countries.All individualswith peripheral neuropathy are normally expected to wear proper footwear and examine their feet daily to detect lesions early which is poorly practiced in these countries.Anyone with a foot injury or open sore is also expected to be restricted to non-weight-bearing activities (ADA 2016).Physicaltherapists and other health care practitioners in Sierra Leone need to be aware of these guidelines and understand how to implement them in clinical practice and health promotion or wellness settings.ADA 2017 confirms that due to lack of training,ithas been estimated that less than one third of physicians recognize the symptoms of diabetic peripheral neuropathy,even when it is symptomatic,and discuss them with their patients[20].

In the current study more women were at risk of developing DFU,women were shown to have more diabetic neuropathy symptoms,PAD due to absent pulse in the PTA and DP together with greater LOPS.This might be the case because less women are engaged in physical activity,poor glycemic control and lipid control due to their eating habit and lifestyle generally[21].Other studies confirm that women with diabetes had worse control of their blood pressure,lipid and glycemic levels compared to males [21].These could explain why our current study showed that more women had history of amputation compared to males;however this is in disparity with other studies which showed that men care less for their feet resulting in a higher prevalence of amputations among them[22],[23].Hence this provides an opportunity for further research to investigate the prevalence of amputation in bothwomen and men and to explore predisposing factors leading to an increase.

Smoking is one of the major risk factors for developing DN[24].The study showed that smoking is associated with some degree of LOPS,symptoms of DN and absent pulse at the PTA and DP.However,interestingly the degree of association of the latter was far lesser compared to those of non-smokers.This might be the case because less smokers participated in the study compared to non-smokers.Studies have confirmed that active smokers had a much lower mean age at amputation compared with non-smokers[25] and smoking cessation improved amputation-free survival in diabetes patients[26].Diabetes is associated with macrovascular complications like atherosclerosis and smoking has also been implicated in causing the latter hence smoking serves as an added risk factor in the formation of plaques and increased mortality in diabetic patients[27].

The culture of regular physical activity in Sierra Leone is still evolving.From observation people believe that exercise can be helpful just once a week which is the norm in Sierra Leone.The American Diabetes Association recommends a150 mins of exercise per week and not to go two consecutive days with no exercise.Apart from limited physical activity,limited diabetes education offered to patients,dietary habits,expensive nutritious foods and adoption of unhealthy lifestyle may be factors which will continue to increase prevalence of diabetes in Sierra Leone.Though evidence is lacking to support this,the aforementioned factors may also contribute largely to impaired management in those already affected with diabetes.Several large randomized controlled trials established that aerobic exercise improves physical fitness,glycemic control,and insulin sensitivity in people with diabetes[28].Therefore,exercise is recommended as a way for people with diabetes to improve glycemic control and minimize diabetic complications.Hence,the study depicts among those that were physically inactive as patients experience a greater LOPS,absent pulse(on the PTA and DP)and more tingling sensation in the extremities compared to those that were physically active.The aforementioned findings are definitely signs of diabetes complications.

Exercise can be very challenging for patients with DN which can limit their mobility and make their condition worse.The Standards of Medical Care in Diabetes position statement published by the American Diabetes Association(ADA) included the recommendation that“in the presence of severe peripheral neuropathy,it may be best to encourage non-weight-bearing activities such as swimming,bicycling,or arm exercises”because of the increased risk of skin breakdown,infection,and Charcot joint destruction.However,there is a controversy on this position statement which shows exercise to be very beneficial among those with DN since it enhances blood circulation in the extremity and many other benefits [29].

According to WHO 2018 [30] the total life expectancy of Sierra Leoneans is 53.1 years.Deaths due to DM in Sierra Leone reached 1,433 or 1.77% of total deaths.The age adjusted Death Rate is 55.85 per 100,000 of population ranks which ranks Sierra Leone 33thin the world.The study clearly showed that increased age (65-75 years) was associated with the greatest LOPS.This is in line with other studies which con-firms that there is an age-related decline in vibration sensation,with almost one-quarter of those older than age 65 years and one-third of those older than 75 years having absent vibration sensation on clinical examination[31].The aged population have less tendency to be physically active or to be compliant to a life-long task which is involved in the management of diabetes.Studies have shown the influence of age which persists even after adjusting for other,very important risk factors,like glycemic control or diabetes duration[32].From the current study it is shown that the aged population had greatest of one of the most limiting symptoms of peripheral neuropathy which is neuropathic pain.Among diabetic patients with neuropathy,11% to 26% have neuropathic pain.In addition,the study showed dramatic increase in absent pulse as age is advanced among the studied population.Studies have shown to confirm this in which there is a striking association between increasing age and prevalence of PAD[33].

Diabetes duration is a major and well-established risk factor of Distal Symmetrical Peripheral Neuropathy (DSPN),regardless of the patient’s age.A strong association have been reported between PDN and the duration of diabetes,especially after 10 years of evolution[34,35].The study conforms to the latter which shows that adults diagnosed after 10 years had greatest associated positive symptoms of DN like tingling sensation,LOPS and absent pulse.

The population prevalence of blindness in Sierra Leone is estimated at 0.7% affecting 43,842 people,while the prevalence of blindness in people over 50 years of age is estimated as 5.9%,according to the most recently available national data[36].There is lack of data on the types of eye diseases associated with diabetes in Sierra Leone.Among participants with eye problems the actual type of eye dis-ease was not captured in the current study.Diabetes causes glaucoma,cataract and diabetic retinopathy (DR).DR is the most common microvascular complication of diabetes with its prevalence highly related to duration of diabetes and poor glycemic control[37].DR is highly related to,nephropathy[38],hypertension[39],and dyslipidemia[40].Researchers at Johns Hopkins University in Baltimore suggest that retina changes in the eye could help detect individuals who are at risk for peripheral artery disease (PAD).The latter research further discovered that individuals who had abnormalities in the small vessels of the retina had double the odds of developing PAD and almost 3.5 times the odds of developing limb ischemia.The association between retinal damage and PAD was strongest among individuals with diabetes.This is in line with the current study which shows that individuals with eye problems had greater absent pulse.

The most common cause of chronic kidney disease (CKD)is diabetes.Patients with CKD and diabetes develop lengthdependent neuropathy of greater severity than do nondiabetic-CKD patients.This is in conformity with current study which reveals that diabetic patients with kidney disease had length dependent neuropathy i.e.positive symptoms like tingling sensation evidence also by loss of protective sensation in more than 2 sites.In Sierra Leone there is no current data on the burden of kidney disease.However,according to the latest WHO data published in 2017 Kidney Disease Deaths in Sierra Leone reached 1,067 or 1.31%of total deaths.The age adjusted Death Rate is 30.74 per 100,000 of population which ranks Sierra Leone 26thin the world.From observation most kidney diseases are caused by hypertension and diabetes among adult Sierra Leoneans.It is sad that only two dialysis center exists currently in the country one owned by a private clinic in Freetown and the other located at Connaught Hospital where machines get faulty sometimes.People can hardly afford to undergo dialysis which increases mortality rate.The cost for each dialysis session is more than $100.It is evident that cardiovascular disease (CVD) related ischemic events are more common in individuals with chronic kidney disease(CKD)[41,42].The presence of PAD in CKD patients markedly increases the short-term risk of heart attack,stroke,and serves as the key cause of limb loss and mortality,with such rates being much greater than that of the general population[43].Hence,the current study shows absent pulse among those with kidney diseases.

V.CONCLUSION

The study clearly showed a high prevalence of participants at risk of developing foot ulcers.Age,occupation,duration of diabetes and type of diabetes was significantly associated with risk of developing DFU.In addition,participants that were physical inactive,had history of kidney and eye disease together with risk of amputation had significant LOPS,absent pulse at the extremities and DN related symptoms especially tingling sensation.

Patients with diabetes are extremely difficult to treat once they develop neuropathy.Identifying the modifiable risk factors for the development of neuropathy and effectively controlling them at an early stage is critical for the successful management of diabetes and preventing serious DPN-related consequences and social disease burden.Hence it is urgent for clinical practitioners in Sierra Leone to use systemic methods,including identification and reduction of risk factors,optimization of metabolic control (e.g.,blood glucose,blood pressure and cholesterol),patient podiatric education and so on,to avoid the onset of foot ulcerations,and reduce limb amputation rate and related mortality.The Ministry of Health and Sanitation should improve on its provision of services by offering certificate courses for health care workers to become diabetes educators.This will go a long way to reduce prevalence of diabetes and its devastating complications.

Authors contribution:

MG developed the project and oversaw the collection of data.JSK advised on the data management and undertook analysis of the data.MG and PE were involved in interpretation of data and critically revising the article.

Competing interests:

The authors declare no conflict of interest.

Funding:

Research was funded by CitiGlobe Pharmacies Ltd.

Acknowledgments:

Ahmed Ramadan for facilitating collection of data.Mark Aruna for being there always and for your brilliant relentless support.My colleague Abdulai Jawo Bah for your support.Mr.Sylvester Kpulun at Sierra Leone Statistics for your great support and patience in making this work a success.

Abbreviations:

DFU,Diabetic foot ulcer;DN,Diabetic neuropathy;DPN,Diabetic peripheral neuropathy;ABPI,Ankle-brachial pressure index;LOPS,Loss of protective sensation;PAD,Peripheral Arterial Disease;PTA,Posterior Tibial Artery;DP,Dorsalis Pedis;LEA,Lower extremity amputation;DSPN,Distal Symmetrical Peripheral Neuropathy;DR,Diabetic retinopathy;CKD,Chronic kidney disease;CVD,Cardiovascular disease.

Ethics approval and consent to participate:

Ethics approval was sought from the Sierra Leone Ethics and Scientific Review Committee and approval granted to conduct the study on human subjects before commencement of research.Informed consent was given to participants and confidentiality was maintained.

Availability of data and materials:

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.