Abstract
Quality of life (QOL) may be impacted by foot ulcer‐related factors, with prevention of diabetes‐related foot ulcers or more effective early healing helping to improve overall patient QOL. This study, which examined the relationship between foot ulcer‐related factors and QOL in patients with diabetes, was conducted as a secondary analysis of a prospective observational study entitled: “Factors associated with the discontinuation of wound care specialist clinic visits in patients with diabetic foot ulcers”. We investigated EQ‐5D‐5L, patient characteristics and foot ulcer‐related factors of 73 patients with diabetes‐related foot ulcers who visited one wound clinic in Indonesia between August 2020 and February 2021. Results showed that the mean health utility was 0.294 ± 0.371. Factors selected for the multiple regression analysis included inflammation/infection of DMIST, first‐ever foot ulcer, and size of DMIST. First‐ever foot ulcer (β = 0.309, p = 0.003) and size of DMIST (β = −0.316, p = 0.015) were significantly associated with the health utility (p < 0.001). Significant improvement in the health utility of 15 patients was observed when the ulcer healed (Wilcoxon signed‐rank sum test, p = 0.001). In conclusion, not only ulcer severity but also the first‐ever foot ulcer itself affected the QOL in patients with diabetes. These results suggest there will be a greater impact on the QOL of patients who develop diabetes‐related foot ulcers for the first time, along with the importance of prevention and early healing, through early infection control and wound size reduction.
Keywords: DMIST, first‐ever foot ulcer, infection, recurrent foot ulcer, wound size
Abbreviation
- QOL
Quality of life
1. INTRODUCTION
Diabetes‐related foot ulcer is one of the complications of diabetes, and defined as a foot ulcer in a patient with current or previously diagnosed diabetes mellitus, and which is usually accompanied by peripheral neuropathy and/or peripheral artery disease in the lower extremity. 1 These ulcers are the most recognizable problem, with reported annual incidence and lifetime prevalence rates of 2%–4% and 19%–34%, respectively. 2 , 3 It was reported that 65.7% healed without amputation by 12 months, 4 while 5% underwent a major amputation within the 1 year follow‐up. 5 Prevention and early healing of diabetes‐related foot ulcers are important because these ulcers affect not only the patients themselves but also their families, placing an economic burden on society. In recent years, its importance has become increasingly high due to the increase in the number of patients with diabetes. 6
The need for prevention and early healing of diabetes‐related foot ulcers has also been recognized from the perspective of quality of life (QOL). Several studies have been conducted on the QOL of patients with diabetes‐related foot ulcers. For instance, the QOL ladder revealed that diabetic patients with chronic foot ulceration were significantly more dissatisfied with their personal lives as compared to diabetic patients without any history of foot ulceration. 7 It was also reported that patients with current foot ulcers rated their health‐related QOL significantly lower than patients who had healed primarily without amputation. 8 In addition, health‐related QOL significantly improved with regard to social functioning and mental health in parallel with the healing of the ulcers, with a deterioration in the social functioning subscale in parallel with the nonhealing of the ulcers. 9 As these studies suggest, the presence of foot ulcers is known to reduce the QOL of patients with diabetes.
Several studies have reported that not only the presence of foot ulcers but also foot‐related factors can affect the QOL. For example, it was reported that the strongest association occurred between biochemical signs of inflammation such as C‐reactive protein (CRP) >10 mg/L, ankle brachial index <0.9, ulcer size >5 cm2, and the health‐related QOL on physical functioning in a study of 127 patients with diabetes‐related foot ulcers. 10 Furthermore, the patients who reported pain most or all of the time had significantly poorer health‐related QOL both statistically and clinically compared to those who did not report pain. 11 In an investigation of 525 patients with diabetes‐related foot ulcers, study results revealed there were statistically significant differences according to the clinical characteristics such as Wagner classification, frequency of foot ulcers, present peripheral vascular disease and pain in terms of QOL. 12 While it is already known that inflammation, infection, blood flow, and wound size can affect the QOL, if the relationship between QOL and more detailed information on wound characteristics such as depth, maceration and necrotic tissue could be clarified among the factors related to foot ulcers, this might make it possible to more effectively improve the QOL and heal foot ulcers at an early stage. Therefore, the purpose of the present study was to examine the relationship between the foot ulcer‐related factors, which included wound characteristics and QOL, in patients with diabetes‐related foot ulcers.
2. MATERIALS AND METHODS
This study was conducted as a secondary analysis of a prospective observational study entitled: “Factors associated with the discontinuation of wound care specialist clinic visits in patients with diabetic foot ulcers.” 13 In 73 patients with diabetes‐related foot ulcers who visited one wound clinic in Indonesia between August 2020 and February 2021, we investigated and followed the QOL and the characteristics of the patients and foot ulcer‐related factors until healing was completed.
QOL was investigated using the Indonesian version of the EQ‐5D‐5L on the day of the first visit and at the time the ulcer had healed. 14 , 15 The EQ‐5D‐5L was originally developed to quantitatively assess health‐related QOL and is currently being used around the world. This includes the descriptive evaluation and an evaluation using a visual analogue scale. In the descriptive evaluation, subjects evaluate their health status for five categories: mobility, self‐care, usual activities, pain/discomfort, and anxiety/depression. A total of five items are used to evaluate each, with this number then converted into a health utility using a formula. A higher health utility value indicates a higher QOL. The visual analogue scale is rated by the subjects, with 100 being the best imaginable state of health and 0 being the worst imaginable state of health.
With regard to the characteristics of the patients, we collected data on age, sex, body mass index, duration of diabetes, HbA1c, blood glucose levels, results for a monofilament test, and ankle brachial pressure index from the medical charts of the patients. For the foot ulcer‐related factors, we collected information on the history of the foot ulcer and the DMIST score. First‐ever foot ulcer was defined as a foot ulcer occurring in a person who has never had a foot ulcer, and recurrent foot ulcer was defined as a new foot ulcer in a person who had a prior history of foot ulceration, irrespective of the location and the time since the previous foot ulcer. 1 DMIST is a validated tool developed to assess the healing process of diabetes‐related foot ulcers. 16 This tool consists of seven items: depth, maceration, inflammation/infection, size, tissue type of wound bed, type of wound edge, and tunnelling or undermining, with the scores ranging from 0 to 34. Higher scores are indicative of more severe disease, with 0 indicating healing.
To examine factors related to the health utility, a t‐test was used for categorical data, and Pearson's correlation coefficient was used for continuous data. Data that showed statistically significant differences in these tests were included as independent variables in a multiple regression analysis using the stepwise method with the health utility used as the dependent variable. At that time, the relationship between the independent variables was confirmed using Spearman's correlation coefficient, and if there was a correlation coefficient of 0.8 or higher, the variable was selected. In the multiple regression analysis, the independent variable categorical data were converted into dummy variables. To clarify changes in the QOL due to healing, changes in the health utility and visual analogue scale were examined using the Wilcoxon signed‐rank sum test, with the descriptive evaluation performed using the chi‐square test. SPSS version 22 was used for the statistical analysis, with a significance level of p = 0.05.
The study was conducted in compliance with the Declaration of Helsinki. This study protocol was approved by the Muhammadiyah School of Nursing Ethics Committee in Pontianak, Indonesia (01/II.I.AU/KET.ETIK/VIII/2020).
3. RESULTS
The mean age of the 73 patients was 55.9 ± 10.0 years, 52.1% were female, mean duration of diabetes was 9.3 ± 7.1 years, and the mean HbA1c was 12.0 ± 1.9%. For the foot ulcer‐related factors, 65.8% were first‐ever ulcers, the mean DMIST total score was 12.3 ± 4.7, and the mean health utility at the first visit was 0.294 ± 0.371.
Univariate analysis revealed that there was a significant relationship between the health utility and the history of the foot ulcer, duration of diabetes, depth, maceration, inflammation/infection, size, tissue type of wound bed of the DMIST score, and DMIST total score (Table 1). Spearman's correlation results showed there was a high correlation between the DMIST total score and the inflammation/infection and size of the DMIST (ρ = 0.829, p < 0.001, ρ = 0.830, p < 0.001, respectively). In addition, the DMIST total score also showed a moderate correlation with the depth, maceration, and tissue type of the wound bed of the DMIST (ρ = 0.742, p < 0.001, ρ = 0.414, p < 0.001, ρ = 0.621, p < 0.001). Therefore, multiple regression analysis using the health utility as the dependent variable was conducted in two ways: using the DMIST total score and using the DMIST items.
TABLE 1.
Factors associated with health utility.
| A. Category data (n = 73) a | |||
|---|---|---|---|
| n | Health utility | p | |
| Sex | 0.897 | ||
| Male | 35 | 0.288 ± 0.382 | |
| Female | 38 | 0.300 ± 0.365 | |
| History of foot ulcers | <0.001 | ||
| First‐ever foot ulcer | 48 | 0.169 ± 0.366 | |
| Recurrent foot ulcer | 25 | 0.534 ± 0.244 | |
| Monofilament test | 0.712 | ||
| Normal | 47 | 0.282 ± 0.373 | |
| Abnormal | 26 | 0.316 ± 0.374 | |
| B. Continuous data (n = 73) b | ||
|---|---|---|
| Correlation coefficient with health utility | p | |
| Age | −0.038 | 0.749 |
| Body mass index | 0.087 | 0.462 |
| Duration of diabetes | 0.231 | 0.049 |
| Ankle brachial index | −0.013 | 0.910 |
| HbA1c levels | 0.029 | 0.807 |
| Blood sugar levels | 0.184 | 0.119 |
| DMIST | ||
| Depth | −0.500 | <0.001 |
| Maceration | −0.298 | 0.010 |
| Inflammation/infection | −0.547 | <0.001 |
| Size | −0.507 | <0.001 |
| Tissue type of wound bed | −0.362 | 0.002 |
| Type of wound edge | 0.126 | 0.287 |
| Tunnelling or undermining | 0.017 | 0.887 |
| Total | −0.609 | <0.001 |
Means±standard deviation, t‐test.
Pearson correlation coefficient.
Multiple regression analysis results that included the total DMIST score, the total DMIST score and the first‐ever foot ulcer showed that these were significantly associated with the health utility (Table 2A). For the multiple regression analysis results that included the DMIST items, inflammation/infection of DMIST, first‐ever foot ulcer and the size of DMIST were selected. The analysis showed that the first‐ever foot ulcer and the size of DMIST were significantly associated with the health utility (Table 2B).
TABLE 2.
Multiple regression models with health utility as the dependent variable.
| A. Models with DMIST's total scores entered (n = 73) a , b | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Model 1 | Model 2 | Model 3 | |||||||
| β | p | VIF | β | p | VIF | β | p | VIF | |
| Age | −0.037 | 0.757 | 1.006 | 0.042 | 0.664 | 1.022 | 0.082 | 0.364 | 1.040 |
| Male | −0.013 | 0.917 | 1.006 | 0.094 | 0.335 | 1.035 | 0.092 | 0.311 | 1.035 |
| DMIST total score | −0.631 | <0.001 | 1.049 | −0.535 | <0.001 | 1.154 | |||
| First‐ever foot ulcer | 0.318 | 0.001 | 1.134 | ||||||
| B. Models with DMIST items entered (n = 73) c , d | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Model 1 | Model 2 | Model 3 | Model 4 | |||||||||
| β | p | VIF | β | p | VIF | β | p | VIF | β | p | VIF | |
| Age | −0.037 | 0.757 | 1.006 | −0.033 | 0.748 | 1.006 | 0.018 | 0.851 | 1.037 | 0.071 | 0.461 | 1.091 |
| Male | −0.013 | 0.917 | 1.006 | 0.011 | 0.913 | 1.007 | 0.020 | 0.834 | 1.008 | 0.103 | 0.299 | 1.139 |
| Inflammation/infection | −0.547 | <0.001 | 1.002 | −0.431 | <0.001 | 1.164 | −0.244 | 0.054 | 1.838 | |||
| First‐ever foot ulcer | 0.314 | 0.004 | 1.198 | 0.309 | 0.003 | 1.199 | ||||||
| Size | −0.316 | 0.015 | 1.917 | |||||||||
Multiple regression analysis, Stepwise method, Adjustment factors: age and being male, Durbin‐Watson: 1.700, VIF: variance inflation factor.
Model 1: F = 0.056, p = 0.945, adjusted R 2 = ‐0.027, Model 2: F = 14.195, p < 0.001, adjusted R 2 = 0.355, Model 3: F = 15.141, p < 0.001, adjusted R 2 = 0.440.
Multiple regression analysis, Stepwise method, Adjustment factors: age and being male, Durbin‐Watson: 1.877, VIF: variance inflation factor.
Model 1: F = 0.056, p = 0.945, adjusted R 2 = ‐0.027, Model 2: F = 9.874, p < 0.001, adjusted R 2 = 0.270, Model 3: F = 10.547, p < 0.001, adjusted R 2 = 0.347, Model 4: F = 10.319, p < 0.001, adjusted R 2 = 0.393.
The average follow‐up period was 21.5 ± 24.9 days. A total of 15 patients were followed until the ulcer healing. 53.3% of them were first‐ever ulcer patients. Patient QOL was significantly improved in all areas after the ulcer had completely healed (Table 3).
TABLE 3.
Changes in health utility, visual analogue scale scores and problems in 5 dimensions due to healing (n = 15).
| First visit | Healing complete | p | |
|---|---|---|---|
| Health utility | 0.542 (0.459–0.617) | 1.000 (0.824–1.000) | 0.001 a |
| Visual analogue scale scores | 70.0 (60.0–80.0) | 95.0 (90.0–95.0) | 0.001 a |
| Mobility | <0.001 b | ||
| No problems | 2 (13.3) | 14 (93.3) | |
| Slight problems | 10 (66.7) | 1 (6.7) | |
| Moderate problems | 3 (20.0) | 0 (0.0) | |
| Severe problems | 0 (0.0) | 0 (0.0) | |
| Unable | 0 (0.0) | 0 (0.0) | |
| Self‐care | 0.003 b | ||
| No problems | 3 (20.0) | 12 (80.0) | |
| Slight problems | 8 (53.3) | 3 (20.0) | |
| Moderate problems | 4 (26.7) | 0 (0.0) | |
| Severe problems | 0 (0.0) | 0 (0.0) | |
| Unable | 0 (0.0) | 0 (0.0) | |
| Usual activities | 0.009 b | ||
| No problems | 3 (20.0) | 12 (80.0) | |
| Slight problems | 8 (53.3) | 3 (20.0) | |
| Moderate problems | 3 (20.0) | 0 (0.0) | |
| Severe problems | 0 (0.0) | 0 (0.0) | |
| Unable | 1 (6.7) | 0 (0.0) | |
| Pain/discomfort | <0.001 b | ||
| No problems | 2 (13.3) | 13 (86.7) | |
| Slight problems | 9 (60.0) | 2 (13.3) | |
| Moderate problems | 4 (26.7) | 0 (0.0) | |
| Severe problems | 0 (0.0) | 0 (0.0) | |
| Extreme problems | 0 (0.0) | 0 (0.0) | |
| Anxiety/depression | 0.001 b | ||
| No problems | 4 (26.7) | 14 (93.3) | |
| Slight problems | 8 (53.3) | 1 (6.7) | |
| Moderate problems | 3 (20.0) | 0 (0.0) | |
| Severe problems | 0 (0.0) | 0 (0.0) | |
| Extreme problems | 0 (0.0) | 0 (0.0) |
Note: Median (quartiles) or n (%).
Wilcoxon signed‐rank sum test.
Chi‐square test.
4. DISCUSSION
This is the first study to examine the relationship between foot ulcer‐related factors, which included wound characteristics and the QOL in patients with diabetes. Results revealed that not only the severity of the foot ulcer but also the fact that it was the first‐ever foot ulcer itself affected their QOL. Focusing on QOL in addition to wound healing and cost is important for patients with diabetes to lead more physically, mentally, and socially fulfilling lives, and the results of this study will contribute to enriching their lives.
In this study, two regression models were proposed: one that included the total DMIST score and one that included the DMIST items. Since this was a secondary analysis, no sample size calculation was performed. However, as a post hoc analysis calculated using the coefficient of determination R 2 (R 2 = 0.471 and R 2 = 0.435 respectively), both models had a power of 0.99. Thus, the number of subjects was sufficient to perform this analysis. Since the variance inflation factor for all models was less than 10.0, there was no problem with the multicollinearity. In addition, the Durbin‐Watson ratios were 1.700 and 1.877, respectively, which suggests that the residuals were likely to be random. In contrast, as the adjusted R 2 was 0.440 and 0.393, respectively, the goodness of fit may not be high. However, the model that includes the total DMIST score appears to have a better fit. Since this study focused on examining the extent of the influence of the independent variables on the dependent variables, rather than trying to find a predictive formula, the point that the fitness was not high should not be considered as a major drawback that threatens the novelty of this study. While we had expected that the use of DMIST would clarify the relationship between the wound characteristics and QOL in more detail, only wound size was found to be associated with the QOL. Wound size may also be indicative of the healing process itself, and thus, both the DMIST total score and the size score may reflect the same perspective of the foot ulcer severity. Moreover, it is no surprise that severe foot ulcers have a negative impact on the QOL, as this has been reported by the result of previous studies. 10 , 12 Therefore, the results of the present study once again suggest the importance of healing the foot ulcers before they can become severe from a QOL perspective. In addition, these findings also suggest that by controlling the infection early and reducing the wound size, this can potentially and greatly contribute to improving the QOL of patients.
It is also of note that our results showed that the first‐ever foot ulcer independently affected the health utility value. To the best of our knowledge, no other studies have compared the QOL of patients with initial and recurrent diseases, even for diseases other than diabetes‐related foot ulcers. In diseases where recurrence implies progression of the disease, recurrence may mean loss of hope. In contrast, first‐time patients may feel a loss of hope and anxiety about their first diagnosis. Diabetes‐related foot ulcers are not only directly linked to restrictions on daily routine activities, but also can lead to anxiety with regard to foot amputation. This can be a major factor in reducing the QOL of first‐time patients. However, most patients with recurrent ulcers have had a successful experience in the past with regard to the healing of ulcers. In addition, it is possible that first‐time patients have yet to accept their foot ulcers, as it has been reported in patients with lower limb amputation that there is an association between the acceptance of illness and their QOL. 17 For patients with diabetes‐related foot ulcers, healthcare professionals need to be aware that the QOL of newly diagnosed patients can oftentimes be significantly affected.
Several studies have examined the QOL of patients with diabetes. 18 In two studies that were conducted in Indonesia, the mean health utility of patients with type 2 diabetes was 0.74 and 0.77, respectively. 19 , 20 Compared to these previous findings, the results of the present study, determined there was a health utility value of 0.294 ± 0.371, which is quite low. Moreover, this low health utility value was found to improve in conjunction with the healing. Thus, these results emphasize the importance of foot ulcer prevention and early healing from a QOL perspective.
However, it should be noted that since this study was a secondary analysis, verifiable data were limited. In particular, because there were many dropouts, verification of the QOL factors was limited to the data that was available at the time of the first visit, and thus, examination of the relationship with the healing was insufficient. Even so, this does not undermine the novelty of the present study in that for the foot ulcer‐related factors, items such as the severity of the ulcer and whether it is a first‐ever ulcer, can affect the QOL.
In conclusion, the findings of the present showed that not only the severity of the foot ulcer but also the fact that an ulcer was the first‐ever foot ulcer itself can affect the QOL in patients with diabetes. Healthcare professionals need to be aware that when patients develop diabetes‐related foot ulcers for the first time, this may have a significant impact on their QOL. Moreover, prevention and early healing of diabetes‐related foot ulcers, through early infection control and wound size reduction, can have a significant effect from a QOL perspective.
FUNDING INFORMATION
This work was supported by JSPS KAKENHI Grant Number 23H03193.
CONFLICT OF INTEREST STATEMENT
The authors declare no conflicts of interest associated with this manuscript.
Oe M, Saad SS, Jais S, Sugama J. Impact of foot ulcer‐related factors on quality of life in patients with diabetes: Prospective observational study. Int Wound J. 2024;21(5):e14895. doi: 10.1111/iwj.14895
Makoto Oe and Supriadi Syafiie Saad equally contributed to this work.
DATA AVAILABILITY STATEMENT
Data sharing is not applicable to this article as no new data were created or analyzed in this study.
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Associated Data
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Data Availability Statement
Data sharing is not applicable to this article as no new data were created or analyzed in this study.