Corresponding author: Maria Polikandrioti, University of West Attica, Athens, Greece; Email:
Diabetic foot ulcers (DFUs) are an inexorable complication of diabetes mellitus which is expanding globally at an alarming rate.[
DFUs are associated with increased morbidly, mortality, and high risk for amputation[
Nowadays, there is a growing awareness of the impact of DFU not only on patients’ bodies but also on their lives including psychological, and social well-being. QoL refers to those physical, psychological, and social domains of health that are influenced by a person’s experiences, beliefs, expectations, and perceptions. Though QoL represents a subjective view, it is a well-accepted tool for evaluation of disease management or assessment of care effectiveness.[
Wagner classification is the most widely used classification system of DFUs.[
Strikingly more, Wagner classification is associated with the potential risk for amputation showing different predictors in different grades. Higher Wagner grade, lower ankle brachial pressure index, serum albumin and hemoglobin as well as the elevated white blood cell count are significantly associated with increased risk of amputation.[
Although the impact of DFUs on QoL is studied in many countries, we need more data referring to QoL in patients with grade 3 ulcer according to Wagner classification system. An in-depth understanding of QoL will enable clinicians to provide beneficial care to this growing group of population.
Therefore, the present study was conducted to determine QoL among DFU patients with grade 3 ulcer by the Wagner classification system and the associated demographic factors.
The present cross-sectional study enrolled 120 outpatients (79 men) attending follow-up visits in an outpatient clinic of a public hospital in Attica between January and October, 2019. It was a convenience sample.
The criteria for including patients in the study were as follows: a) patients with type 2 diabetes with grade 3 DFUs according to Wagner classification; b) adequate attendance of follow-up visits during the study period; and c) patients that are able to write and read the Greek language fluently. The exclusion criteria were as follows: a) patients with a history of mental disorders; b) patients with foot lesions due to trauma after any type of accident; c) patients with other severe or chronic diseases which are not associated with diabetes; d) patients that are unable to communicate throughout the study period; and e) patients with ulcers in other grades by Wagner classification than grade 3. In terms of race/ethnicity all patients were Greek.
The Wagner diabetic foot ulcer classification system we used to recruit only grade 3 ulcer patients uses the following grades[
Grade 0 – intact skin
Grade 1 – superficial ulcer of skin or subcutaneous tissue
Grade 2 – ulcers extend into tendon, bone, or capsule
Grade 3 – deep ulcer with osteomyelitis, or abscess
Grade 4 – partial foot gangrene
Grade 5 – whole foot gangrene
This widely used DFU grading system has the advantages of simplicity and ease of bedside application while it does not require sophisticated laboratory or imaging tests.[
The interview lasted approximately 15 minutes and for all participants it took place while they were waiting for their clinical follow-up in the outpatient setting.
The study was approved by the Medical Research Ethics Committee of the hospital where it was conducted. The study was performed in full accordance with the Declaration of Helsinki (World Medical Association, 1989). Prior to data collection, the patients were explained the nature and objectives of the study. All patients participated in the study voluntarily and had their anonymity preserved. Written informed consent was obtained from all patients being interviewed.
Data collection was performed by completing the SF-36 Health Survey (SF-36) and a questionnaire which included the patients’ self-reported demographic characteristics (gender, age, marital status, educational level, profession, place of residence, and number of their children).
The SF-36 Health Survey (SF-36) scale was used to assess patients’ QoL. This scale assesses physical and mental health. It consists of 36 questions comprising 8 dimensions: physical functioning, role-physical, role-emotional, energy/fatigue, emotional well-being, social functioning, pain, and general health. Respondents answer the questions on Likert-type scales. The scores assigned to the questions are summed up separately for the questions that evaluate the 8 dimensions. Higher scores indicate better QoL.[
Categorical data are presented with absolute and relative frequencies (%) while continuous data are presented with median and interquartile range since they did not follow the normal distribution (tested with Kolmogorov-Smirnov criterion and graphically with Q-Q plots and histograms). Non-parametric Mann-Whitney and Kruskal-Wallis tests were used to test for association between patients’ QoL and characteristics.
In addition, multiple linear regression analysis was performed to test which independent factors were independently significantly associated with QoL after testing for potential confounders. Results are presented as β regression coefficients and 95% confidence interval (95% CI). The observed level of 5% was considered significant. All statistical analyses were performed with SPSS version 22 (SPSS Inc, Chicago, IL, USA).
Sample demographic characteristics (n=120)
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Sex (Males) | 79 (65.8%) | Job | |
Age (years) | Unemployed | 2 (1.7%) | |
30-40 | 3 (2.5%) | Public servant | 10 (8.3%) |
41-50 | 11 (9.2%) | Private employee | 10 (8.3%) |
51-60 | 18 (15.0%) | Freelancer | 13 (10.8%) |
61-70 | 58 (48.3%) | Household | 18 (15.0%) |
71-80 | 30 (25.0%) | Pensioner | 67 (55.8%) |
Family Status | Residency | ||
Married | 86 (71.2%) | Attica | 75 (62.5%) |
Single | 10 (8.3%) | County capital | 23 (19.2%) |
Divorced | 14 (11.7%) | Small city | 8 (6.7%) |
Widowed | 10 (8.3%) | Rural area | 14 (11.7%) |
Education | Number of children | ||
Primary | 29 (24.2%) | None | 15 (12.5%) |
Secondary | 43 (35.8%) | One | 28 (23.3%) |
University | 46 (38.3%) | Two | 56 (46.7%) |
MSc PhD | 2 (1.7%) | More than two | 21 (17.5%) |
Patients’ QoL
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Physical functioning (range: 0–100) | 22.5 (±10.7) | 22 (16-27) |
Role physical (range: 0–100) | 35.4 (±41.1) | 0 (0-75) |
Role emotional (range: 0–100) | 38.9 (±45.2) | 0 (0-100) |
Energy/fatigue (range: 0–100) | 57.1 (±20.1) | 60 (45-70) |
Emotional well-being (range: 0–100) | 66.5 (±18.8) | 72 (52-84) |
Social functioning (range: 0–100) | 61.7 (±27.0) | 50 (50-87.5) |
Pain (range: 0–100) | 63.8 (±28.5) | 67.5 (45-90) |
General health (range: 0–100) | 48.0 (±20.1) | 48.5 (35-65) |
Physical health (range: 0–100) | 44.7 (±16.9) | 43.5 (32-55.6) |
Mental health (range: 0–100) | 55.7 (±23.9) | 56 (34-76) |
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Physical health score above 50 | 44 (±43.3%) | |
Mental health score above 50 | 68 (±56.7%) |
±SD: standard deviation; IQR: interquartile range
Physical functioning was significantly associated with the place of residence (
Physical role was significantly associated with age (
Emotional role was significantly associated with age (
Energy/fatigue was significantly associated with age (
Emotional well-being was significantly associated with gender (
Regarding social functionality, it was significantly associated with marital status (
Pain was significantly associated with education level (
General health was significantly associated with marital status (
Association between patient’s characteristics and QoL (physical functioning, role physical, role emotional)
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Sex | 0.929 | 0.178 | 0.868 | |||
Male | 23 (16-26) | 0 (0-50) | 0 (0-100) | |||
Female | 22 (16-30) | 25 (0-100) | 0 (0-100) | |||
Age (years) | 0.075 | 0.020 | 0.012 | |||
≤50 | 24 (20-27) | 75 (0-100) | 100 (0-100) | |||
51-60 | 26 (21-38) | 0 (0-0) | 0 (0-0) | |||
61-70 | 21 (14-26) | 25 (0-75) | 17 (0-100) | |||
>70 | 25 (20-28) | 0 (0-75) | 0 (0-67) | |||
Family status | 0.158 | 0.156 | 0.016 | |||
Married | 23.5 (16-28) | 12.5 (0-100) | 17 (0-100) | |||
Single / Divorced / Widowed | 22 (16-26) | 0 (0-50) | 0 (0-67) | |||
Education | 0.172 | 0.481 | 0.051 | |||
Primary | 20 (14-25) | 0 (0-50) | 0 (0-33) | |||
Secondary | 22 (18-26) | 25 (0-100) | 0 (0-100) | |||
University | 26 (15.5-31) | 25 (0-75) | 33 (0-100) | |||
Job | 0.385 | 0.018 | 0.012 | |||
Employee | 26 (19-28) | 25 (0-75) | 10 (0-100) | |||
Pensioner | 22 (15-27) | 0 (0-75) | 0 (0-100) | |||
Residency | 0.005 | 0.444 | 0.160 | |||
Attica | 22 (15-26) | 25 (0-75) | 33 (0-100) | |||
County capital | 28 (22-38) | 0 (0-75) | 0 (0-33) | |||
Small city / Rural area | 20 (14-26) | 0 (0-50) | 0 (0-67) | |||
Number of children | 0.268 | 0.931 | 0.980 | |||
None | 26 (22-26) | 0 (0-50) | 0 (0-100) | |||
One | 24.5 (20-29.5) | 0 (0-75) | 17 (0-100) | |||
Two | 20.5 (11-26.5) | 12.5 (0-62.5) | 0 (0-100) | |||
More than two | 22 (16-26) | 50 (0-75) | 0 (0-100) |
IQR: Interquartile range
Association between patient’s characteristics and QoL (energy/fatigue, emotional well-being, social functioning)
Energy/fatigue | Emotional well-being | Social functioning | ||||
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Median (IQR) | Median (IQR) | Median (IQR) | ||||
Sex | 0.076 | 0.009 | 0.798 | |||
Male | 60 (50-75) | 76 (52-84) | 50 (50-87.5) | |||
Female | 55 (35-65) | 68 (48-76) | 62.5 (50-87.5) | |||
Age (years) | 0.026 | 0.802 | 0.228 | |||
≤50 | 57.5 (50-70) | 74 (52-80) | 75 (50-100) | |||
51-60 | 70 (60-75) | 74 (64-84) | 50 (37.5-75) | |||
61-70 | 57.5 (50-70) | 68 (48-84) | 50 (50-87.5) | |||
>70 | 50 (30-65) | 72 (48-84) | 50 (50-87.5) | |||
Family status | 0.018 | 0.115 | 0.001 | |||
Married | 60 (50-75) | 72 (56-84) | 62.5 (50-100) | |||
Single / Divorced / Widowed | 50 (35-65) | 68 (44-80) | 50 (25-50) | |||
Education | 0.125 | 0.001 | 0.053 | |||
Primary | 55 (30-65) | 52 (40-68) | 50 (50-50) | |||
Secondary | 60 (45-75) | 72 (48-88) | 75 (50-100) | |||
University | 57.5 (50-70) | 76 (66-84) | 50 (50-75) | |||
Job | 0.009 | 0.007 | 0.147 | |||
Employee | 70 (55-75) | 76 (68-84) | 50 (37.5-75) | |||
Pensioner | 55 (35-65) | 64 (48-84) | 50 (50-87.5) | |||
Residency | 0.161 | 0.948 | 0.464 | |||
Attica | 55 (40-70) | 68 (52-84) | 50 (50-100) | |||
County capital | 55 (35-70) | 72 (60-80) | 50 (50-75) | |||
Small city / Rural area | 65 (60-75) | 76 (52-84) | 50 (37.5-75) | |||
Number of children | 0.430 | 0.056 | 0.408 | |||
None | 50 (45-75) | 76 (48-80) | 50 (25-100) | |||
One | 60 (55-75) | 80 (68-84) | 75 (50-100) | |||
Two | 60 (37.5-70) | 64 (48-84) | 50 (43.75-81.25) | |||
More than two | 55 (45-60) | 68 (56-76) | 50 (50-100) |
IQR: interquartile range
Association between patient’s characteristics and QoL (pain, general health)
Pain | General health | |||
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Median (IQR) | Median (IQR) | |||
Sex | 0.203 | 0.604 | ||
Male | 57.5 (45–90) | 45 (35–65) | ||
Female | 75 (45–100) | 50 (40–65) | ||
Age (years) | 0.102 | 0.184 | ||
≤50 | 95 (57.5–100) | 38.5 (25–50) | ||
51-60 | 57.5 (55–67.5) | 52.5 (40–70) | ||
61-70 | 67.5 (45–77.5) | 50 (40–65) | ||
>70 | 76.25 (45–100) | 42.5 (25–60) | ||
Family status | 0.172 | 0.034 | ||
Married | 67.5 (45–90) | 50 (40–65) | ||
Single / Divorced / Widowed | 50 (45–90) | 40 (27–55) | ||
Education | 0.010 | 0.205 | ||
Primary | 45 (45–67.5) | 50 (27–60) | ||
Secondary | 67.5 (32.5–100) | 50 (40–65) | ||
University | 72.5 (56.25–100) | 45 (35–70) | ||
Job | 0.711 | 0.087 | ||
Employee | 67.5 (57.5–100) | 50 (40–70) | ||
Pensioner | 67.5 (45–90) | 45 (35–60) | ||
Residency | 0.362 | 0.024 | ||
Attica | 67.5 (45–100) | 50 (35–65) | ||
County capital | 67.5 (45–77.5) | 40 (27–50) | ||
Small city / Rural area | 57.5 (32.5–70) | 65 (40–65) | ||
Number of children | 0.063 | 0.175 | ||
None | 67.5 (55–100) | 40 (32–55) | ||
One | 77.5 (62.5–100) | 45 (40–60) | ||
Two | 57.5 (45–90) | 55 (40–65) | ||
More than two | 55 (32.5–70) | 40 (27–60) |
IQR: interquartile range
Multiple linear regression analysis was then performed with dependent variables the sub-groups of patient’s QoL to estimate the effect of patient characteristics (independent factors).
Concerning emotional well-being, it is observed that female patients had 10.3 points worse emotional well-being than men did (β=-10.3; 95% CI: -16.7–3.8;
Impact of patient’s characteristics on QoL (physical functioning, role physical, role emotional)
Physical functioning | Role physical | Role emotional | ||||
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β (95% CI) | β (95% CI) | β (95% CI) | ||||
Age (years) | ||||||
≤50 | - | Ref. Cat. | Ref. Cat. | |||
51-60 | - | -55.59 (-84.81–26.6) | 0.001 | -53.7 (-84.5–22.9) | 0.001 | |
61-70 | - | -29.1 (-55.1–2.97) | 0.029 | -25.2 (-52.8–2.35) | 0.073 | |
>70 | - | -33.1 (-61.1–5.1) | 0.021 | -41.3 (-71.1–11.5) | 0.007 | |
Family Status | ||||||
Married | - | - | Ref. Cat. | |||
Single / Divorced / Widowed | - | - | -16.7 (-34.22–0.62) | 0.059 | ||
Job | ||||||
Employee | - | Ref. Cat. | Ref. Cat. | |||
Pensioner | - | -5.24 (-23.8–13.37) | 0.578 | 3.28 (-16.9–23.5) | 0.748 | |
Residency | ||||||
Attica | Ref. Cat. | - | - | |||
County capital | 8.15 (3.12–13.1) | 0.001 | - | - | ||
Small city / Rural area | 0.49 (-4.49–5.49) | 0.843 | - | - |
CI: confidence interval; Ref. Cat.: reference category
Impact of patient’s characteristics on QoL (energy/fatigue, emotional well-being, social functioning)
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Sex | ||||||
Male | - | Ref. Cat. | - | |||
Female | - | -10.3 (-16.7–3.8) | 0.002 | - | ||
Age (years) | ||||||
≤50 | Ref. Cat. | - | - | |||
51-60 | 5.2 (-7.1–17.4) | 0.406 | - | - | ||
61-70 | -4.9 (-16.2–6.3) | 0.385 | - | - | ||
>70 | -9.9 (-21.8–1.9) | 0.100 | - | - | ||
Family Status | ||||||
Married | Ref. Cat. | - | Ref. Cat. | |||
Single / Divorced / Widowed | -8.4 (-15.3–1.4) | 0.018 | - | -20.1 (-30.2–10.0) | 0.001 | |
Education | ||||||
Primary | - | Ref. Cat. | - | |||
Secondary | - | 7.9 (-0.2–16.0) | 0.055 | - | ||
University | - | 12.0 (3.9–20.0) | 0.004 | - | ||
Job | ||||||
Employee | Ref. Cat. | Ref. Cat. | - | |||
Pensioner | -5.7 (-13.8–2.2) | 0.156 | -11.2 (-18.2–4.2) | 0.002 | - |
CI: confidence interval; Ref. Cat.: reference category
Impact of patient’s characteristics on QoL (pain, general health)
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Family status | ||||
Married | - | Ref. Cat. | ||
Single / Divorced / Widowed | - | -6.7 (-14.6–1.1) | 0.093 | |
Education | ||||
Primary | Ref. Cat. | - | ||
Secondary | 10.9 (-2.1–23.9) | 0.101 | - | |
University | 16.4 (3.1–29.7) | 0.016 | - | |
Residency | ||||
Attica | - | Ref. Cat. | ||
County capital | - | -4.9 (-14.2–4.5) | 0.302 | |
Small city / Rural area | - | 8.2 (-1.0–17.5) | 0.080 |
CI: confidence interval; Ref. Cat.: reference category
The present results showed low QoL levels in physical functioning, role physical and role emotional, and moderate QoL levels in general health. Similar observations were made in a recent meta-analysis of 12 studies which showed poor QoL in four of eight subscales of SF-36: physical functioning, role physical, general health, and vitality.[
When compared to patients with no ulcer, the DFU ones have poor QoL[
In terms of age, the finding that participants below 50 years reported better QoL in physical and emotional role is almost in line with Al-Maskari et al.[
Results also revealed better QoL among participants of higher education in emotional well-being (vitality), while patients of primary education experienced more pain. Al-Maskari et al.[
Married participants had better QoL in emotional role, vitality, social functioning, and general health. Possibly, support provided in marital bonds prompts patients to develop adaptive mechanisms or to handle the disease more effectively, thus having better QoL. The family was shown to be the main source of support in a cross-sectional study of 140 DFU outpatients.[
Compared to married participants, the single ones had 8 and 20.1 points worse QoL in energy/fatigue and in social functioning, respectively. Aschalew et al.[
In terms of occupation, employees had better QoL in physical role, emotional role, energy/fatigue, and emotional well-being. Employment status and DFU seem to have an interactive relationship. On the one hand, DFU management may lead to unemployment, prolonged medical leave, and increased economic costs for patient. On the other hand, unemployment may be threatening to health state. In more detail, unemployment may increase DFU onset mainly through unhealthy behaviours such as smoking, lack of regular exercise, obesity, heavy alcohol drinking or sleeping <6 hours per night.[
Concerning gender, male patients had better QoL in emotional well-being. AlSadrah et al.[
Last but not least, DFU patients living in a small town or rural areas had worse physical functioning. A possible contributor to the lower QoL is the rural related issues, such as lack of immediate access to specialized medical help or transportation difficulties, especially in winter, limited information and living standards.[
DFUs as a chronic condition need multidisciplinary interventions which are promising to meet the complexity of patients’ needs. This approach includes several professionals from different sectors, such as nurses, physicians, psychotherapists, and occupational therapists.[
This study has some limitations. Convenience sampling is one of the limitations since this method is not representative of all population with DFU grade 3 living in Greece, thus limiting the generalizability of results.
The present sample size was relatively small, although many significant associations were observed.
Moreover, there was no other measurement in future time that would allow evaluation of possible changes in QoL. It would be interesting to compare QoL and association with demographic characteristics among different stages of Wagner classification.
Results of the present study showed the following:
Age was associated with physical and emotional role and energy/fatigue.
Gender was associated with emotional well-being.
Marital status was associated with emotional role, energy/fatigue, social functionality, and general health.
Occupation was associated with physical and emotional role, energy/fatigue, and emotional well-being.
Level of education was associated with emotional well-being and pain.
Place of residence was associated with physical functioning and general health.
Evaluation of association between patients’ demographic profiles and QoL is essential to provide a context for improvement in ulceration management. Also, this measurement may enable clinicians to provide specialized education tailored to the patients’ needs. Thereinafter, better QoL means a significant decrease in the economic burden of DFU for both patient and the health care system.
This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
The author declares no conflict of interest.
The study was approved by the Medical Research Ethics Committee of the hospital.
Written informed consent was obtained from all individual participants included in the study.
All procedures performed in the studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.