|Year : 2021 | Volume
| Issue : 2 | Page : 151-154
Influence of body mass index on developing ulceration in patients with venous disease: A case–control study
Pearl Lal1, Edwin Stephen2, Prabhu Premkumar2, Albert Abhinay Kota2, Vimalin Samuel2, Sunil Agarwal1, Dheepak Selvaraj2
1 Division of General Surgery, Christian Medical College, Vellore, Tamil Nadu, India
2 Department of Vascular Surgery, Christian Medical College, Vellore, Tamil Nadu, India
|Date of Submission||03-Jun-2020|
|Date of Acceptance||15-Jun-2020|
|Date of Web Publication||13-Apr-2021|
Department of Vascular Surgery, Christian Medical College, Vellore, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Aim: The aim of this study was to assess the influence of body mass index (BMI) on the development of ulceration in patients with venous disease. We also analyzed other risk factors that might lead to the progression of disease to ulceration. Design: A prospective case–control study from January 2016 to June 2017. Materials and Methods: This study was conducted at the vascular surgery outpatient department of a tertiary care hospital in India. One hundred and thirty cases with an active or healed venous ulcer were compared with 130 controls with no ulceration. A questionnaire was administered to look at the factors that influence the risk of developing ulceration. The patients underwent a clinical examination and the clinical class of venous disease was documented using the Clinical, Etiological, Anatomical and Pathophysiological classification. The patient's height and weight were measured, and the BMI was calculated. Results: The mean BMI of the study population was 29.04. Nearly 38.8% of the 260 patients recruited were obese and another 38.8% were overweight. Nearly 35.4% of the cases and 42.3% of the controls were obese. About 45.5% of the obese patients had an active or healed ulcer. About 77.8% of the patients with recurrent ulcers were either overweight or obese. However, on comparing the BMI between the cases and controls, there was no statistically significant difference. On multivariate analysis, we found older age, male gender, deep-vein thrombosis, and prolonged periods of standing, to have a significant association with ulceration in venous disease. Conclusion: Our study suggests that there is no association between BMI and ulceration in patients with venous disease. Older age, male gender, deep-vein thrombosis, and periods of prolonged standing have a higher association with venous ulceration.
Keywords: Chronic venous disease, chronic venous insufficiency, obesity, varicose veins, venous ulcer
|How to cite this article:|
Lal P, Stephen E, Premkumar P, Kota AA, Samuel V, Agarwal S, Selvaraj D. Influence of body mass index on developing ulceration in patients with venous disease: A case–control study. Indian J Vasc Endovasc Surg 2021;8:151-4
|How to cite this URL:|
Lal P, Stephen E, Premkumar P, Kota AA, Samuel V, Agarwal S, Selvaraj D. Influence of body mass index on developing ulceration in patients with venous disease: A case–control study. Indian J Vasc Endovasc Surg [serial online] 2021 [cited 2021 Jun 24];8:151-4. Available from: https://www.indjvascsurg.org/text.asp?2021/8/2/151/313569
| Introduction|| |
Venous ulcers affect approximately 0.3% of the population. There are, as such no prevalence studies conducted in India for venous ulcers, but one study estimated the prevalence of chronic wounds as 4.48 per 1000 population. While there are many causes for chronic wounds, venous ulcers constitute a significant proportion as is evident in the large numbers that are seen in the vascular outpatient department. There are many studies which have highlighted the impact of venous insufficiency, especially venous ulcers on the quality of life of an individual. In the Indian setup, quality of life is of paramount importance because it affects mainly those from the middle and low socioeconomic status and often results in a change of occupation. Some of the risk factors that have been described for chronic venous insufficiency are older age, male sex, obesity, family history, history of phlebitis, and previous leg injury., If we look at obesity alone, worldwide, obesity has more than doubled since 1980. According to the WHO, in 2014, 39% of the adults over 18 years of age were overweight and 13% were obese. Asian Indians are more predisposed to the accumulation of visceral fat, truncal, and abdominal obesity. Hence, Indians are more likely to develop lifestyle-related diseases, at a lower body mass index (BMI) compared to their Caucasian counterparts. The Chennai Urban Rural Epidemiology Study conducted in the Chennai city in Tamil Nadu reported the prevalence of obesity to be as high as 45.9%. What remains unclear is if obesity is by in itself an etiological factor for chronic venous insufficiency or it merely worsens the severity of venous reflux, and hence, exacerbates the disease. Hence, its role in chronic venous insufficiency needs to be studied. There are data to show that healing rates are slower for venous ulcers among the obese and also that they are more likely to recur. The increased intraabdominal pressure influences the lower limb venous hemodynamic and raises venous pressures by causing reduced venous outflow, stasis, and worsens venous reflux. However, the muscle pump action is found to be better in the obese. Most Western studies that have looked at this aspect are descriptive studies with a few using suitable controls. Further, the population included in these studies had more cases with early disease as compared to the Indian population where we tend to see more patients with the advanced forms of venous disease. Keeping the above facts in mind, this study was planned to compare the patients with venous ulceration to patients who have venous disease but no ulceration.
The aim of this study was to assess the influence of BMI on the development of ulceration in patients with venous disease. We also analyzed other risk factors that might lead to the progression of disease to ulceration. The primary objective of the study was to find the association between BMI and venous ulcers. Our secondary objective was to look at other etiological factors that are associated with advanced stages of the disease.
| Materials and Methods|| |
This prospective, observational, case–control study was conducted at the vascular surgery outpatient department of a tertiary care hospital in India from January 2016 to June 2017.
Inclusion criteria: All patients who presented with a documented venous insufficiency using a duplex scan were enrolled into the study after signing an informed consent. Enrolled patients were clinically examined in the using the clinical, etiological, anatomical, and pathophysiological classification. The clinical grade of venous disease of the patients was documented for each limb. Patients with C0 and C1 disease were excluded. One hundred and thirty consecutive patients with C5 or C6 disease were enrolled as cases, and 130 consecutive patients with C2–C4 disease were enrolled as controls. The cases and controls were subjected to a questionnaire, which included patient's demographic data and predisposing factors to ulceration in patients with venous disease, such as number of hours of standing, history of trauma to the limb, history of deep-vein thrombosis, type of lifestyle, smoking, comorbidities, usage of compression stockings, family history of venous disease, and usage of oral contraceptive pills. The height and weight of each of the cases and controls were measured. BMI was calculated. By the WHO criteria, a BMI of 25–29.99 was defined as overweight and a BMI of 30 or more was defined as obese. All of them had a documented venous duplex showing venous insufficiency. Venous duplex findings were taken from the electronic data records of patients. This study was approved by the Institute Review Board Min. No. 9739 dated November 10, 2015.
The sample size calculation was based on a previous study, where the mean (standard deviation [SD]) of BMI was 31.7 (8.4) and 29.1 (6.4) in the two arms, respectively. The sample size was calculated to be 130 in each arm using the mean difference of 2.6 and with the provided SDs with 80% power using a two-sided hypothesis test and critical level of significance of 5%.
Data from the case report form were entered into the Epidata version 3.1 The Epidata Association, Odense, Denmark, data entry software and then exported to SPSS. Data were summarized as mean ± SD/median (range) for continuous variables, frequency along with the percentage for categorical variables. Independent t-test was used to compare the continuous variables among the cases and controls. Similarly, the Chi-square test was performed to compare the categorical variables among the cases and controls. The estimate of effect size was presented as odds ratio (OR) (95% confidence interval [CI]). A multiple logistic regression was performed to analyze the adjusted effect of variables over the case and control. The goodness of fit was tested using Hosmer–Lemshow test and McFadden's R2 was reported. In addition, the continuous variables among the BMI subgrouping were analyzed using ANOVA/Kruskal–Wallis test based on the normality along with pairwise comparison, the categorical variables were compared using the Chi-square test. All the analysis was performed using STATA I/C 13.1 StataCorp LP, Stata Press, Texas, USA.
| Results|| |
Out of the 260 participants recruited for the study, there were 203 males and 57 females. The mean age of the study population was 46. Of the 130 controls, 79 had C2 disease, 50 had C3 disease, and 56 had C4 disease. Of the 130 cases, 55 had C5 disease and 92 had C6 disease. The mean height of the study population was 165 cm, and mean weight was 79.5 kg. The BMI of the study population ranged from 17.60 to 53.50. As shown in [Table 1], the mean BMI of the cases and controls was 28.73 and 29.34, respectively. Predominant part of the population belonged to the overweight and obese categories. 38.8% of the 260 patients recruited were obese and 38.8% were overweight.
The number of patients with active ulcers in the overweight and obese category was more compared to the ones with healed ulcers [Figure 1]. On comparing the BMI with the C stage within the controls, we found that there was similar number of obese patients in all the C categories, with more overweight participants with C2 disease [Figure 2].
|Figure 2: Distribution of body mass index in each C stage of the controls|
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However, there was no statistically significant difference in the BMI between the two arms (OR = 0.98, 95% CI = 0.94–1.02). There was no statistically significant difference in both obesity (OR = 0.57, 95% CI = 0.29–0.34, P = 0.446) and overweight between the controls and cases (OR = 0.6,7 95% CI = 0.34–1.31). As the BMI classification proposed for the Asian population is different, we compared the two arms with the specified categories. However, there was no statistically significant difference between the controls and cases ( P = 0.263).
We analyzed the factors such as age, gender, recurrent ulcerations, number of hours of standing, history of trauma to the limb, history of deep-vein thrombosis, type of lifestyle, smoking, comorbidities, usage of compression stockings, family history of venous disease, and usage of oral contraceptive pills. Most of our patient population was middle aged with a mean age of 46.7 years. There were more males than females. Even though classically varicose veins have been described to be more common in females, only 21.9% of our study population was female. We found a significant association between the male gender and ulceration in venous disease. The mean duration of ulcer in those with C6 disease was 32.72 months, ranging from 1 month to 360 months, with a SD of 54.64. Among the cases, 72 patients (55.4%) had recurrent ulcers with a mean recurrence of 4.08 (range: 1–20). There were more recurrences in patients who were overweight or obese; however, it was not statistically significant ( P = 0.702).
The type of lifestyle was similar between the two groups, with predominant part of the study group among both the cases and controls leading a sedentary lifestyle. There were 66 smokers in the study population. Forty-two out of the 130 cases smoked, whereas 24 out of the 130 controls gave a history of smoking, which was statistically significant between the two arms ( P = 0.010) (OR = 2.10, 95% CI = 1.19–3.75). However, on multivariate analysis, it was not found to be statistically significant between the cases and controls ( P = 0.178) (OR = 1.59, 95% CI = 0.81–3.16). The mean number of hours of standing in the study population was 5.08 h. Prolonged periods of standing were statistically significant between the controls and cases ( P = 0.034). Hence, it can be considered as one of the factors that have an association with ulceration in patients with venous disease (OR = 1.16, 95% CI = 1.08–1.26). Seven cases and one control gave a history of deep-vein thrombosis in the past in the right limb. Eighteen cases and three controls had a past history of deep-vein thrombosis in the left limb. History of deep-vein thrombosis was statistically significant in both the limbs ( P = 0.05). Twenty-two patients in the study population had chronic thrombosis on the duplex, out of which twenty were patients with active or healed ulcers. Among the cases, 60% belonged to the overweight category. We then took the patients who had chronic deep-vein thrombosis either historically or on duplex and found that it was statistically significant between the cases and controls (OR = 10.08, 95% CI = 2.96–34.31) ( P < 0.001). On multivariate analysis, it continued to be a statistically significant factor, and hence, associated with ulceration in patients with venous disease (OR = 13.15, 95% CI = 3.43–50.31). The duplex characteristics between the cases and controls were compared and were found to be similar between the two groups and similar across all BMI categories.
Using the factors that were found to be significant, a multivariate analysis was done. As shown in [Table 2], the following were found to be statistically associated with venous ulceration: Older age, male gender, deep-vein thrombosis, and prolonged periods of standing.
| Discussion|| |
Both obesity and venous ulcers are a common problem in India. Venous ulcers are difficult to heal requiring long-term treatment and tend to recur. A systematic review showed that venous ulcers, hence, have a negative impact on all aspects of daily living. Lifestyle changes continue to play an integral role in the treatment of venous ulcers. Because of the significant morbidity associated with them and the huge socioeconomic impact, it is imperative to identify the etiology and the factors that lead to progression of chronic venous insufficiency to ulceration. This would help us identify the patients who are at an increased risk of developing ulcers early, target them and thus take appropriate measures to prevent the progression of the disease. Hence, this study was designed with the aim to assess the influence of BMI on the development of ulceration in patients with venous disease. Prior studies done in patients with venous insufficiency have shown an association between obesity and advanced stages of venous disease. However, most of them have shown an association in females but not in males. It was evident that most of the patients with venous insufficiency in our study were either overweight or obese. However, there was no statistically significant difference between those with ulcers and those with no ulcers as far as BMI was concerned. The criteria to recruit the patients for our study were to have a documented venous insufficiency on a venous Duplex. A study by Padberg et al. showed that there might be no anatomic evidence of venous insufficiency in the obese, suggesting that probably the etiology in them is different. Hence, the investigators did consider the possibility of a different pathophysiology of venous disease in the obese, and hence, venous duplex alone might not be an adequate diagnostic tool to select obese patients for future studies.
About 55.4% of the cases had recurrent ulcers with a mean recurrence of 4.08. This highlights the huge morbidity that is associated with venous ulcers. Recurrent ulcers would mean more visits to the hospital, more number of loss of days at work and an overall increased socioeconomic burden for the patient. Nearly 77.8% of the patients with recurrent ulcers were either overweight or obese.
Our data reflected that only 41.9% of our study population had used compression stockings. This despite the fact that compression is the mainstay of treatment for venous insufficiency. Only 10% of the patients gave a history of exercising regularly while a predominant part of them led a sedentary life. Nearly 32.30% of the cases were smokers, and it was a statistically significant factor between the two arms of the study. Probably, more awareness needs to be created among our patients regarding lifestyle changes and compliance to compression stockings for the treatment of venous disease.
On multivariate analysis, we found older age, male gender, deep-vein thrombosis, and prolonged periods of standing, to have a significant association with ulceration in venous disease. As a limitation of our study, there is a possibility of a recall bias as our data on the etiological factors was based on the history given by the patients.
There was no association between BMI and ulceration in patients with venous disease in our study. However, we did consider the possibility of a different pathophysiology of venous disease in the obese, and hence, venous duplex alone might not be an adequate diagnostic tool to select obese patients for future studies. We propose that further studies need to be done in this regard and follow-up the obese patients in the control arm to see if they develop ulcers in the future. It is only then that we will be able to establish obesity as risk factor.
| Conclusion|| |
The results of our study did not show an association between BMI and ulceration in patients with venous disease. We also found that older age, male gender, deep-vein thrombosis, and periods of prolonged standing to have a higher association with venous ulceration. However, in order to categorically state that obesity and venous ulceration have no association, a study with far larger numbers is needed.
Financial support and sponsorship
Financial support was provided by the IRB fluid research grant.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]