INTRODUCTION:

Nearly 15% of diabetic populations in India are getting affected by diabetic foot ulceration. Nearly 65 million people in India is affected by diabetes out of which 25% develop DFU and 50% of people are affected with infected ulcers and 205 are ultimately leading to amputations with increased morbidity. Cost effect of treatment of DFU is increased and leading in India for the complete DFU treatment¹.

²Diabetic Foot Ulcer (DFU) is a common and a major complication of Diabetes Mellitus where the foot lesions have significant effect on socioeconomic status and health related quality of life. It contributes largely to morbidity and mortality of patients and has involves long-term hospitalization and also have a risk of Amputation. Peripheral neuropathy, peripheral vascular disease. Foot trauma, poor podiatric care, poor glycemic control, obesity, malnutrition includes the risk of DFU with low quality of life.

²Body mass index (BMI [kg/m2]) is recommended as a way of classifying their weight as being either underweight (BMI < 18.5), healthy weight (BMI 18.5 to 24.9), overweight (BMI 25 to 29.9) or obese (BMI > 29.9). Deviations away from the healthy weight range are associated with a lower health-related quality of life (HRQoL). Diabetic patients with overweight and obesity draw a major attention in literatures having increased prevalence of DFU¹. ³Nutritional status in DFU patients helps in speedy recovery and quick healing of lesions. But as the grading of lesion is increased in patients nutritional status is decreased leading to malnutrition. Poor nutritional status has an increased risk of amputation in DFU patients. Prognosis gradually declines and leading to increased length of hospital stay and low quality of life in patients^{3. 4}Patients with many risk factors should have preventive care for foot ulcers. Poor glycemic control, peripheral neuropathy, pre ulceration, callosities, obesity, malnutrition, hypertension, poor podiatric care are the general risk factors supported by the literatures where the patients is in wide need of life style interventions thus improving the health-related quality of life in DFU patients⁴.

The ultimate goal of the study is to create a possible relation between body weight, malnutrition, lifestyle modifications in health related quality of life and thus creating and providing an improved knowledge of preventive care in Diabetic foot ulcer patients and associated risk in patients.

METHODOLOGY:

Subject selection:

Our study was designed as a cross sectional study for a period of 6 months (December 2018- May 2019). A total of 90 patients were recruited whose signed informed consent form was obtained, from Employee State Corporation Multispecialty Hospital based on the study’s inclusion and exclusion criteria, among which 51 patients were male and 39 patients were female

Inclusion criteria:

Patients aged over 18 years and should be diagnosed with diabetic foot syndrome, Patients who are giving consents and the Participants need to be free from medications known to alter body weight, nor having a history of restricted dieting in the previous year.

Exclusion criteria:

Diabetic patients who had traumatic ulcer due to accident and those who were unable to communicate independently. Pregnant and nursing women were excluded from the study. Patients who are not willing to participate in the study and the patients who failed to provide written consent form were excluded from the study.

Procedure:

Approval of the study protocol by the Institutional Ethics Committee (Ref:) of VISTAS was obtained before the commencement. After obtaining the informed consent form from the subjects they were provided with the WHO-BREF questionnaire and blood samples were collected from the patients by vein puncture method, where the site of injection was cleaned with cotton swab using spirit. Estimation of serum albumin was carried out and analyzing the impact of body weight, lifestyle modification and malnutrition on health-related quality of life of patients with Diabetic foot ulcer and to draw a plausible relationship between them.

Statistical analysis:

All data collected was compiled in Microsoft excel sheet, Graph Pad Prism version 8.0 and IBM SPSS software was used for statistical analysis. Results were expressed as the Mean ±SD. Spearman correlation was used to assess associations between variables(BMI and quality of life, Nutrition and quality of life. T-test was used to compare results of lifestyle modification and health related quality of life. P values reported were two tailed, and P at 0.05 is considered significant.

RESULTS:

Out of 90 patients included in the study 51 patients (56.67%) were male patients and 39 patients (43.44%) were female patients. Table 1 shows the baseline characteristics used in this study which is expressed as mean± standard deviation. Body weight was used in the estimation of BMI of the patient, serum albumin obtained from the patient was used in the estimation of Nutrition risk index score for the analyses of effect of nutrition in quality of life and smoking, alcohol are the lifestyle parameters used to assess their effects on quality of life. Table 2 helps to understand the effect of body weight on health related quality of life involving four domain categories: physical domain, psychological domain, social relationship domain and environmental domain (as shown in Figure 1, 2). Table 3 helps to understand the effect of nutrition on health related quality of life involving four domain categories of WHO-BREF scores (as shown in Figure 3, 4). Table 4 and 5 shows the smoking and alcoholic effects regarding the patient’s lifestyle modification on quality of life scores.

Table 1: Baseline Clinical Characteristics

Age	56.2±7.6
Male	51(56.67%)
Female	39(43.33%)
BMI	25.56±5.02
NRI score	98.93±8.72
WHO-BREF(DOMAIN-1)	51.12±14.3
WHO-BREF(DOMAIN-2)	52.81±20.36
WHO-BREF(DOMAIN-3)	60.93±24.5
WHO-BREF(DOMAIN-4)	53.32±22.47
ALCOHOLIC	34.4%
NON-ALCOHOLIC	65.56%
SMOKER	37.78%

Table: 2 Determination of effect of body weight on health related quality of life (bmi vs. Who-bref domain scores)

Domains	R value	95% confidence interval	P value
Physical domain	-0.4151	-0.5771 to -0.2217	<.001
Psychological domain	-0.3443	-0.5192 to -0.1417	<.001
Social relationship domain	-0.2970	-0.4797 to -0.08963	.004
Environmental domain	-0.4281	-0.5876 to -0.2367	<.001

Table: 3 Determination of effect of Nutrition on health related quality of life (Nri vs. Who-Bref Domain Scores

Domains	R value	95% confidence interval	P value
Physical domain	0.322	0.117 to 0.501	.002
Psychological domain	0.326	0.121 to 0.504	.002
Social relationship domain	0.329	0.124 to 0.506	.002
Environmental domain	0.295	0.0874 to 0.478	.005

Table:4 Effect of lifestyle modification with QOL score

Variable	Smoker (n=33)	Non-smoker (n=56)	p- value
QOL score	212.1± 66.27	238.1± 69.20	<0.0001

Table: 5 Effect of lifestyle modification with QOL score

Variable	Alcoholic (n=30)	Nonalcoholic(n=60)	p- value
QOL score	170.3± 50.10	242.2 ± 68.59	<0.0001

Figure-1 Effect of body weight on health related quality of life (BMI vs Physical domain)

Figure-2 Effect of body weight on health related quality of life (BMI vs Phsychological domain)

Figure-3 Effect of nutrition on health related quality of life (NRI vs Social relationship domain)

Figure-4 Effect of nutrition on health related quality of life (NRI vs Environmental domain)

DISCUSSION:

Many reports were published based on the health related quality of life in diabetic and diabetic foot ulcer patients in which some studies reported a poorer quality of life in diabetic patients having been reported with DFU.^5-7Nearly 4-10% of diabetic populations are getting affected by DFU and in India the prevalence rate of DFU is increasing with 11.6%.¹Studies shows that compared with normal weight (18.5 < BMI < 25kg/m2) patients, over weight and obese diabetic patients were 2.12 times and 2.65 times more likely to develop Diabetic foot ulcer. There was an evidence to suggest that presence of high foot pressure in over weight and obese patients might decrease the normal blood circulation pattern at lower extremities leading to reduced HRQoL in diabetic foot ulcer patients.^8-10In this study it was reported the relationship between body weight, nutritional status social habits on health related quality of life in DFU patients. Out of 90 patients analyzed almost all with increased body weight showed poor quality of life with reduced domain scores and this relationship was found to statistically significant. As with increasing body weight the plantar pressure on the feet increased leading to delayed and poor healing of ulcer which creates a great impact in day to day activities.²Nutritional status is the most required for the quick and proper conduction of angiogenesis process for good healing of wounds. Malnutrition is very common among DFU patients leading to poor prognosis suggesting that nutrition plays a key role in quality of life in DFU patients. In this study the nutritional status was assessed with the Nutritional Risk Index score calculated from the patients serum albumin measurement and it was found that the poor nutritional status was found in patients with increased grading of wounds and the respective health related quality of life was decreased. The relationship was found to be statistically significant. ³Poorer glycemic control, peripheral neuropathy, hypertension, poor podiatric care leads to increased risk of DFU suggesting that effective intervention in life style modifications will have improved quality of life in DFU patients. In this the study the patient with smoking and alcoholic were assessed to have low domain scores since these social habits makes the glycemic parameters to increase abnormally thus make the poor healing of wounds. The underlying mechanisms involved the effect of body weight and malnutrition proves that the normal weight range and proper nutrition are the baseline requirements for timely healing and improved quality of life.

CONCLUSION:

In our study it is found that being overweight and obese was associated with the reductions in HRQoL, was statistically significant as measured using WHO-BREF questionnaire. And also from the data it was cofound that as grading of foot ulcer gets increased has an impact on HRQoL and it was found to be statistically significant. Nutritional assessment using NRI scores was also found to be significant with HRQoL measurement and thus maintaining normal nutritional status will increase the quality of life of patients and improvement in healing of ulcer at a faster rate. Life style modifications were significant with HRQoL and therefore life style modifications can also evidence for blood glucose control and other complications involving limb amputations. We support the fact that quality of life assessment in patients with DFU helps in the timely finding of their quality of life thus improving the treatment options and improved patient care. Patient counseling regarding the disease, infection, life style modifications should be provided to DFU patients to sustain their quality of life. Further studies are needed to explore the relationship between demographic and clinical variable

ACKNOWLEDGEMENT:

The authors would like to thank Chairman Iswari. K. Ganesh of VISTAS and Physicians of the tertiary care hospital for their constant support.

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Received on 07.05.2019 Modified on 29.06.2019

Research J. Pharm. and Tech. 2020; 13(1): 106-109.

DOI: 10.5958/0974-360X.2020.00021.9