Prevalence of diabetic related foot disease in Palakkad, Kerala, INDIA

 

Asma PK¹, Muneer R E², Srikanth Putte Gowda², Pradeep Kumar KM³, Soopy Kayanaduth^3*

 

 

Abstract              Background: Diabetes related foot disease (DRFD) describes a number of complications of diabetes that can occur simultaneously or in isolation. Peripheral vascular disease (PVD), peripheral neuropathy (PN), foot ulceration and amputation contribute significantly to the high rates of morbidity and mortality affecting individuals with diabetes.Despite the great burden on the health care system and the individual, prevalence of this grave long term complication of DRFD has not been documented well in Kerala, India.The main objective of the study is to determine the prevalence of this grave complication of diabetes mellitus, DRFD. Methodology: This is a prospective study which is conducted in Kerala Medical College Hospital, Palakkad, during January -February 2018. The research encompasses a questionnaire that is a previously established survey tool that discloses the presence or absence of DRFD using self-reported symptoms. Four hundred and twenty diabetic patients both type I and type II, who came for their regular follow up were interviewed.The Edinburgh claudication Questionnaire (ECQ), the diabetic Neuropathy Symptom Score(NSS) and two questions relating to the remaining components of DRFD, foot ulcer and amputation were included. Result: On evaluating subjects with NSS 190 (45.2%) were having significant diabetic neuropathy symptom score (DNS) indicating that the vast majority of patients with diabetic neuropathy were symptomatic. On evaluating for symptoms of claudication using the Edinburgh Claudication Questionnaire (ECQ) 318 (75.7%) patients were having a score of zero which indicates that they did not have any symptoms of claudication and 102 (24.3%) of the included subjects were having both grade 1 and grade 2 claudication., 30 (7.1%) patients had positive history of ulceration in the lower extremities, regarding amputation 20 (4.76%) had positive history of amputation. Conclusion: The prevalence of DRFD using survey tool that is self- reported symptoms appear to be consistent with international reports of community prevalence for all components of DRFD.

Key Words: Diabetes related foot disease, Diabetes mellitus, Claudication, Peripheral neuropathy.

 

INTRODUCTION

Diabetes related foot disease (DRFD) describes a number of complications of diabetes that can occur simultaneously or in isolation. It includes peripheral vascular disease (PVD), peripheral neuropathy (PN), foot ulceration and amputation¹. Neuropathy is considered the most common micro-vascular complications of both types 1 and 2 diabetes mellitus².Diabetic polyneuropathy (DPN) affects the peripheral nervous system and is by far the most common type of neuropathy seen in diabetic mellitus (DM)³. The resultant loss of function in peripheral nerves causes loss of protective sensations and impairs patient’s ability to perceive incipient or even apparent ulcerations in the feet. DPN is considered a main risk factor for amputation, and hence a significant cause of morbidity in DM⁴. Peripheral artery disease (PAD) is an important healthcare problem in developed nations and is associated with considerable morbidity and mortality. Intermittent claudication (IC) is the most common symptomatic manifestation of PAD, and typically occurs in up to one third of patients with this disease. Intermittent claudication is characterized by pain, aching or cramping in the calf, buttock, hip or thigh on ambulation that resolves upon rest. Symptoms arise from an inadequate blood supply to the peripheral arteries of the legs that result in anaerobic metabolism and buildup of lactic acid within the muscles. Only about a quarter of patients with IC will ever significantly deteriorate⁵⁷. Intermittent claudication can be diagnosed with the use of a questionnaire along with evidence of PAD. The Edinburgh Claudication Questionnaire (ECQ) was first validated by Leng et al.,⁸in 1992 after noting that the previous WHO/Rose questionnaire had low sensitivity. This patient administered questionnaire was administered to a predominantly European population and was found to be 91.3% sensitive and 99.3% specific for IC (Intermittent Claudication) in comparison to a doctor made diagnosis⁵.Diabetic foot ulceration (DFU) is full-thickness penetration of the dermis of the foot in a person with diabetes. Three types of DFU are known: neuropathic, ischemic and neuro-ischemic ulcers. Neuropathic ulcers are characterized by loss of sensation with intact peripheral pulses with intact sensation. In neuro-ischemic ulcers both sensation and peripheral pulses are absent. The dominant type of ulcers varies in different populations but the neuropathic ulcer appears to be the most common while the ischemic type is the least common. Poor glycemic control is highly associated with neuropathic ulcers while dyslipidemia and diastolic hypertension are significantly associated with ischemic ulcers. The major etiologies include neuropathy which is characterized by loss of pain and vibration sensation resulting in a high likelihood of trauma to the lower extremities as a result of prolonged exposure of the feet to injurious conditions. Congenital and acquired deformities of the foot place more pressure on the plantar surfaces of the feet and ultimately result in ulceration^9,10. The most dreaded end-result of DFU is lower extremity amputation. The hyperglycemic state is associated with immunoparesis and poor wound healing. Therefore the compounding effect of high rate of bacterial infection on poorly healing wound provokes an inflammatory cascade resulting ultimately in tissue necrosis and gangrene; often lower extremity amputation is inevitably offered when DFU becomes gangrenous and life threatening^11-13.Complications affecting the lower limbs are among the most common manifestations of diabetes; it was reported that 15% of diabetic patients will eventually suffer from foot ulceration during their lifetime¹⁴.These complications are a frequent cause of hospitalization and disability; with one in five hospitalizations among diabetes directly related to foot ulcers¹⁰. The prevalence of diabetes related foot disease varies regionally and the present study aim to collect the data of pervasiveness of DRFD in Palakkad district of Kerala, the southern state of India.

 

MATERIALS AND METHODS

This is a prospective study which is conducted in Kerala Medical College Hospital Palakkad, during January -February 2018, specifically upon those attendees at the diabetic outpatient clinic as they attend for a routine appointment. The research encompasses a questionnaire that is a previously established survey tool that discloses the presence or absence of DRFD using self-reported symptoms. Data collection was through an interview. Four hundred and twenty diabetic patients both type I and type II, who come for their regular follow up were interviewed. Those patients with already established dyslipidemia, chronic renal failure those who are chronic smokers were excluded from the study. The questionnaire includes questions from previously established survey tools. The Edinburgh claudication Questionnaire(ECQ): an improved version of the WHO/Rose questionnaire for use in epidemiological survey, the diabetic Neuropathy Symptom Score(NSS) and two questions relating to the remaining components of DRFD, foot ulcer and amputation were also included.

Statistical Analysis: Statistical analysis was performed using the software origin-8 (Origin LAB, Origin Lab Corp., MA, USA).

 

RESULTS

A total of 450 patients were invited and 445 responded, the absence for non-response was due to unwillingnessof the patients to take part in the study. Twenty five patients were excluded from the study because they have other factors which can cause peripheral neuropathy and/or peripheral vascular disease. A total of four hundred and twenty patients were included in this study. The mean age was 50.16±20.42 (range 20-85) with equal gender distribution. Baseline characteristics of the study group are given in (Table 1). Among the study group 140 (33.3%) were having type 1 diabetes mellitus and the rest had type 2 diabetes. The mean duration of diabetes mellitus in years was 8.93±5.69 (range1-34).

DISCUSSION

Diabetes related foot disease is a common complication of DM. This is a first comprehensive report among diabetic patients in Palakkad pertaining to all forms diabetic foot. Our study has used a scoring system which is an already established survey tool for epidemiological studies that is DNS and ECQ, a simple clinical scores useful to diagnose peripheral neuropathy and peripheral vascular disease respectively. These survey questions were based on the most commonly occurring symptoms for these two pathologies and required dichotomous 'yes/no' responses^9,11. For sensory PN and/or PVD to be identified based on symptomology, one or more of the nominated symptoms must have been present for a minimum of one month, have occurred consistently over that time period and could not potentially be related to any other pathology. The symptoms used in order to diagnose sensory neuropathy were burning, tingling, numbness, pins and needles and tightness, whilst the PVD symptoms included claudication and rest pain.Although clinical examination may be the desired option for determining absolute disease prevalence, it is unfortunately a costly and time consuming exercise, and in our settings lack of trained podiatricians and equipments which are necessary for the assessment of peripheral neuropathy and peripheral vascular disease makes it more difficult to establish the absolute prevalence of DRFD using clinical assessment along with subjective symptoms.The age group category which is depicted in Table 2 is analyzed against the four symptoms of neuropathy (unsteadiness, prickling, burning, numbness), intermittent claudication grade, and ulceration. When analyzed against the first symptom of neuropathy that is unsteadiness the p value is  <0.001, for prickling the p value is 0.000,  for burning the p value is 0.009, for numbness the p value is 0.000. Since the p values for the four symptoms of neuropathy is below the significant p value as age increases the prevalence of neuropathy also increases.When the age category is analyzed against claudication grade (0, 1, 2) almost equal number of the participants from all age group do not have claudication (grade 0), but as for grade 1 and grade 2 as the age increases the number of participants who have claudication grade 1 and grade 2 increases there are no participants in the age group 20 to 45 who has grade 2 claudication, the p value is 0.001.The presence of ulcer analyzed against age category gives a p value of 0.081, which is not significant. When presence of ulcer analyzed against gender gives a p value of 0.444, which is not significant. When both types of diabetes mellitus (type1 and type 2) are analyzed against claudication grade, There are no type 1 participants who have grade 2 claudication and there are more type 2 participants who have grade 1 claudication, the p value is 0.005, this could be confounded by the age distribution as participants with type 2 diabetes mellitus are much older than participants with type 1 diabetic mellitus.Fasting Plasma Glucose (FPG) analyzed against symptom of peripheral vascular disease (PVD) that is claudication, those participants with FPG level greater than 200 are more affected by claudication giving a p value 0.000. Prevalence ratings calculated appear to be consistent with international reports of community prevalence for all components of DRFD. Diabetes prevalence data is sourced from the World Health Organization and is compiled using local epidemiological studies and surveys.Amputation is not included in as most international studies report findings as incidence rates not as prevalence rates, so there is little data available for comparison. Unfortunately there is no any local data which is established previously which we can compare with the current study. We tried to compare our prevalence rate of the current study with a similar study which is done in Australia in 2003which encompasses all aspects of Diabetic Related Foot Disease (DRFD), but this research used clinical assessment to establish the prevalence data. The survey findings from this study do differ somewhat from the findings of the 2003 AusDiab foot complications study. Using clinical examination to determine presence or absence of PN and PVD, AusDiab reported prevalence for PN to be just 13.1% in those with known diabetes¹⁶. This is significantly lower than our current study prevalence rate which was 45.2%. The AusDiab findings are also significantly lower than those reported in other international studies. Findings for prevalence of PVD and ulceration were more consistent across studies, with AusDiab reporting prevalence rates of 13.9% for PVD and 3.0% for ulceration compared with prevalence rate for PVD of 24.3% and prevalence rate for ulceration of 7.1% from this study.The optimal therapy for DRFD is prevention through identification of high risk patients, and it can be done by regular podiatric care. Patients at risk for foot ulcers should understand the implications of sensory loss (that is loss of protective sensation) and learn to check for and recognize impending foot problems⁵. Patient’s education should  emphasize on careful selection of footwear, daily inspection of the feet to detect early signs of poor-fitting footwear or minor trauma, daily foot hygiene to keep the skin clean and moist, avoidance of self-treatment of foot abnormalities and high risk behaviors (example, walking barefoot) and prompt consultation with a health care provider if an abnormality arises¹¹. Direct evidence of a link between glycemic control and healing is lacking; however, glycemic control is likely to be important, since leukocyte function is impaired in patients with chronic hyperglycemia⁴.Patients should be advised to stop smoking, not only because smoking may affect vascular factors, but also because smokers have higher rates of incisional-wound infections than nonsmokers or former smokers³.The principles of management of neuropathic ulcers include eradication of infection and removal of pressure from the ulcer^5,17. The benefit of removing pressure from a neuropathic foot ulcer (i.e., reducing mechanical stress, or off-loading) is well established.Techniques for removing pressure include the use of casts or boots, half shoes, sandals, and felted foam dressings^15,18.

 

 

 

CONCLUSION AND RECOMMENDATIONS

Application of this survey tool to determine the prevalence of DRFD is essential as there is no any podiatric unit to determine the early forms of DRFD  like PVD (sensory peripheral vascular disease) and PN (peripheral neuropathy). Most of the diagnosed DRFD are when they present in their gross form like ulcer, edema, callus and amputation. So determining the presence or absence of DRFD using self-reported symptoms could be as a temporary podiatric unit thereby the clinician can advise on foot care to those which were determined to have the minor forms of DRFD and both the patient and the healthcare provider could work in tackling the problem from progressing to its severe form, thereby reducing disability (burden for the patient, healthcare and the country as a whole).The limitations of using survey tools that is self- reported symptoms alone to determine presence or absence of disease must be acknowledged. In particular, the impact accuracy of self-reporting of disease symptoms can have on overall findings and the potential for over estimation of disease prevalence is a consideration.However, results from this study do not indicate an overestimation of disease prevalence, when findings are compared to similar population based studies reported from other countries (Table 4). Further to this, any over estimation of disease prevalence that does not result in significant cost or harm to the relevant patient group or the health system, makes slight variation from true estimates acceptable. What must also be acknowledged is the potential for sensory PN to mask the signs and symptoms of PVD and the possibility that a proportion of those who develop this type of PN will do so with no symptoms. Whilst acknowledging the impact this would have on the reliability of determining disease prevalence is using a survey alone, the inclusion of 'Doctor diagnosis' acts to reduce the likelihood of this group being undetected.As age increases the prevalence of neuropathy also increases, since the p values for the four   symptoms of neuropathy is below the significant p value  (p value is less than 0.005 for the four symptoms of neuropathy).The symptoms of claudication also increased in those participants with increased age group. Those participants with type 2 diabetes mellitus suffer more from symptoms of claudication andit may be due to patients with type 2 diabetes are older than patients with type 1. It is also noted that participants with FPG level greater than 200 are more affected by symptoms of PVD and the prevalence of ulceration was not affected by gender.

 

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