Abstract
Aims
The goal was to gather and assess information about the features of patients suffering from Diabetic Foot Syndrome with active ulcers. This data was compared to findings gathered by a designated researcher for evaluation.
Materials and Methods
This cross-sectional observational study was designed using data from a validated survey.
Results
We conducted 102 surveys, revealing positive data on the respondents’ knowledge, awareness, attitudes, and practices. However, discrepancies appeared between the participants’ self-assessments, the researcher's evaluations and the actual implementation of recommendations, such as wearing inappropriate footwear, not moisturizing the feet or avoiding walking more than an hour while there is an active ulcer.
Conclusion
Despite participants showing positive knowledge, awareness, attitudes, and practices, it is crucial to enhance educational measures in regular clinical practice. This would further reinforce patients’ preventative actions against DFU in everyday life.
Practice Implications
This study highlights the need to enhance patient education and preventative measures in clinical practice, ensuring patients consistently apply knowledge to prevent diabetic foot ulcers daily.
Keywords
Introduction
The World Health Organization (WHO) defines diabetes mellitus (DM) in its World Diabetes Report as a severe chronic illness that arises when either the pancreas fails to produce sufficient insulin or the body cannot properly utilize the insulin it generates. As of 2014, it is estimated over 422 million adults were diagnosed with this condition. Projections suggest that by 2035, almost 630 million individuals could be living with diabetes. 1
DM brings several complications for patients, including the potential for heart and kidney diseases, neurological and eye abnormalities, and Diabetic Foot Syndrome (DFS). Each of these comorbidities significantly reduces a patient's quality of life, posing the risk of limb amputation and even premature death. Among the conditions, DFS has the highest prevalence in diabetic patients. It is estimated that 10%–25% of these patients will likely develop diabetic foot ulcers (DFU) at some point in their lives. 1
DFS, according to WHO, 2016, refers to the condition marked by infection, ulceration, and the breakdown of deep tissues in the lower extremities, coupled with neurological impairment and varying levels of peripheral vascular disease. The primary driver of this syndrome is ongoing high blood sugar, resulting in peripheral neuropathy and peripheral arterial disease (PAD). 2
DFU affect between 7.2%–15% of patients with DM, although some recent studies suggest this figure could rise to 34%. The overall prevalence is 6.3%, typically higher in men and in those with type 2 diabetes. 3 Between 5%–24% of DFU cases may necessitate amputation within 6–18 months of their initial appearance. Post-amputation, life expectancy sadly diminishes significantly; approximately 50% of amputees pass away within 5 years following the procedure.3,4
Consequently, DFS often leads to serious complications that heighten social and economic burdens, as well as amplify morbidity and mortality rates. Furthermore, the need for patients with DFS to alter their habits can significantly deteriorate their quality of life. 5
We must arrest this progression, seen as a public health issue, by utilizing preventative tools. These may not be popular among clinicians and researchers,6,7 but they have been proven to decrease all ulcerative foot lesions from DFS by up to 75%. 4 The International Working Group on Diabetic Foot (IWGDF) staunchly advocates for the introduction of preventative educational strategies. These aim to enhance patients’ familiarity with foot self-care and aid them in acquiring the requisite skills to adhere to recommended guidelines.7,8 Advice includes wearing suitable footwear for patients with neuropathy and carrying out daily self-inspections or regular self-maintenance to avert ulcers. Self-care practices encompass maintaining foot cleanliness, ensuring dryness between the toes, and using emollients for skin moisturization.7,9 To establish effective preventative educational programs, we need data on the characteristics of patients with DFS and active ulcers. This information aids in the proper design, promotion, development, and implementation of high-quality preventative programs.
The goal of this study is to collect and analyze information on the attributes of patients with DFS and active ulcers. The data will then be compared to those procured by a research evaluator.
Material and Methods
Data Collection
Patient characteristics data for this study was collected using a survey. A single investigator, conducted these surveys while patients visited a specialized Diabetic Foot Unit and fulfilled the selected criteria. Sampling was done via a non-probability convenient sampling technique. The survey had 40 questions in total—33 focused on the patient's knowledge, attitudes, practices, and awareness, while the remaining seven were for the evaluating researchers, about the patient's medical condition. The survey was administered in a suitable healthcare setting to ensure interviewee comfort and confidentiality. The data collection spanned 6 months (from January to June 2024).
Validation of the Measurement Tool
The survey was designed, and its validity was confirmed through an analysis of the internal consistency of the questions, which was determined using Cronbach's alpha coefficient. The resulting high overall internal consistency of the test demonstrates its reliability. Details on the block analysis of this consistency can be found in Table 1. This survey was used to assess knowledge, awareness, attitudes, and practices in patients with DFU (Table 1). We further verified its reliability with a correlation analysis using Pearson's correlation coefficient, achieving a high positive correlation result of 0.953.
Internal Consistency of the Survey Used for the Assessment of Knowledge, Awareness, Attitudes and Practices in Patients with Diabetic Foot Ulcer.
To ensure unbiased analysis, the data from the survey was evaluated by two independent researcher, separate from the researcher who collected the data, after the survey was completed.
Ethics
This cross-sectional observational study was approved by the ethics committee of under the favorable opinion number 23/189-E. It was conducted by adhering to the Declaration of Helsinki guidelines. 10 All necessary data was collected in a single visit, eliminating the need for follow-up sessions due to the study's design.
Sample Size Calculation
The sample size was determined using data from previous studies conducted with the Granmo program from Barcelona's Institut Municipal d’Investigació Mèdica. We based our sample size estimation on the population of the district where the specialized diabetic foot unit is located and the primary quantitative variable, ‘ulcer recurrence’, which we assumed to occur in 30% of the population, as indicated by previous studies such as that of Armstrong et al. 11 We set a 95% confidence interval along with a 5% margin of error. No need was identified to set a replacement percentage. Consequently, the calculations yielded an estimated sample size of 89 individuals.
Inclusion Criteria
Patients agreed to participate in the study once they met the inclusion and exclusion criteria, reviewed the patient information sheet, and signed the informed consent form. Those who attended a unit specializing in diabetic foot management consecutively and voluntarily were included in the study provided they met the inclusion criteria and did not meet any of the exclusion criteria.
The inclusion criteria specified that men and women legally of age with any type of medically diagnosed diabetes, regardless of their current medication, were eligible, provided they had an active ulcer at the time of the survey.
We stipulated that the study should exclude patients who would previously had a major amputation or required assistance from caregivers or services for managing their disease. The data was collected and evaluated over a period of 6 months (from January to June 2024).
Data Analysis
The collected data was analyzed by two independent researchers. A statistical analysis was conducted, which involved a descriptive examination of quantitative variables presented as absolute frequencies and percentages. The calculation of the mean, median, and standard deviation was used to analyze these quantitative variables.
We used the statistical tests, Cronbach's alpha and Pearson's correlation, to validate the questionnaire through IMB SPPS Statistics® version 27 software.
We used the Cronbach's alpha test to assess this survey's internal consistency. Generally, the patient self-report modules showed alphas ranging from 0.47 to 0.87 (Table 1, which give the survey's internal consistency used to evaluate knowledge, awareness, attitudes, and practices in patients with diabetic foot ulcers). Yet, the entire survey demonstrated an internal consistency of 0.83, confirming its high reliability.
Pearson's correlation analysis was conducted on data from repeat tests provided by 10% (n = 10) of the total study participants. The same evaluator, administered these tests, in which participants completed the same survey twice, with a one-week interval in between. This approach facilitated an analysis of the degree of correlation between the two test results.
The comprehensive analysis of data collected from participants with DFS and DFU is given here. This data includes their understanding, perception, attitudes, and behaviors. Furthermore, it includes data from benchmarking conducted by the evaluating researcher. All of this information can be referred to comprehensively in this document (Table 2). The table lists the results of analyzing knowledge, attitudes, behavior, and awareness. For a comparative view, refer to Table 3, which contrasts the patient's personal expectation with the clinical reality.
Table of Results Obtained from the Analysis of the Blocks of Knowledge, Awareness, Attitudes and Practices.
Abbreviations: Dk/Da, Don't know/Dońt answer; N/A, Not applicable; DM, Diabetes mellitus; PAD, Peripheral arterial disease; DFU, Diabetic foot ulcer.
Comparison of the Results Between the Patient's Point of View (Personal Expectation) and the Clinical Reality.
An independent researcher analyzed all the collected data. Two separate researchers, closely supervised both the data collection and analysis processes.
Results
After applying our inclusion and exclusion criteria, we interviewed 102 patients. Most of the participants were male (n = 82; 80.4%) and majorly had type 2 diabetes (n = 53; 52%). The patients had an average age of 69 ± 11.46 (mean ± SD) years, and the average duration of their diabetes was 21 ± 14.17 (mean ± SD). They were generally overweight, with a mean BMI of 27.5 ± 4.25 (mean ± SD). However, their glycosylated haemoglobin (HbA1c) levels were high, averaging 7.02%; 53 mmol/mol. Additionally, a significant portion of participants were unaware of their HbA1c levels (n = 59; 58.8%) and their type of diabetes (n = 34; 33.3%).
The results of the data analysis on knowledge, awareness, attitudes, practices, and evaluations can be seen in Table 2. This includes the comprehensive percentages assessed by the researcher. Table 2 provides detailed results from the analysis of knowledge, awareness, attitudes, and practice blocks.
Knowledge Block
The data analysis indicated that over 50% of participants understood the neurological and vascular changes related to the disease, as well as their connection with the onset and poor prognosis of ulcers.
Awareness Block
Participants primarily acknowledged the benefits of self-care in preventing injury. This refers to regular inspections, hydration, wearing suitable shoes, maintaining a balanced diet, exercising, resting, and attending podiatric clinics often.
Patients responded positively to learning more about their pathology. Seventy (69.6%) participants indicated that they had never received specialized education about DFS.
Self-Management Block
Many participants admitted to using foot care-based techniques. Patient reports showed that despite acknowledging the importance of the suggested rest, many engaged in discouraged activities like stair-climbing or heavy lifting.
When comparing the results of the awareness and practice block in the category of shoe inspection as a preventive measure for reulceration, a statistically significant difference was found (p ≤ .001).
Similarly, we found a statistically significant difference when comparing the results between awareness of rest until remission of the ulcer and the actual practice of the patients (p = .03). On the other hand, we found a statistically significant difference in the category of walking for more than one hour (p = .021) in patients who stated that they did take the recommended rest. Although we did not find a statistically significant difference in daily foot inspection (p = .116), we found a clinically significant difference, as 26% did not practice daily foot inspection (see Table 3).
Researcher Assessment
The researcher's assessment unveiled discrepancies between the participants’ perspectives and the actual findings. These significant divergences are notably demonstrated in Table 3. The table spotlights the gap between patient expectations of self-management techniques and their actual clinical impact. Notably, these differences are most evident in foot and footwear inspection, foot hydration, and proper footwear usage. When comparing the differences obtained between the reality assessed by the researcher and the patients’ expectations, we found statistically significant differences in the lack of foot hydration (p ≤ .001), the use of inappropriate footwear (p ≤ .001), and correct foot hygiene (p ≤ .001).
Discussion and Conclusion
Discussion
Complications related to DFS, such as ulcers, pose a significant risk to patients, impacting their overall health and mortality rates, as well as their quality of life. 12
Leading experts in the field suggest that to halt the progression of DFS, we need to create efficient preventative educational programs.1,8 Evidence from studies conducted by healthcare professionals further underscores the need to strengthen patient education, particularly regarding the risks of recurrence and the importance of adherence to prescribed preventative measures and self-care practices. 13
These programs should equip patients with practical tools for everyday use, aiming to prevent any potential complications. The WHO (1989) recommends that all healthcare professionals involved in patient care should provide preventative knowledge to the patient.
Given the high percentage of HbA1c ignorance (n = 59; 58.8%) alongside an average value that exceeds recommended levels (7.02%; 53 mmol/mol), we suggest initiating patient empowerment programs. These educational initiatives have been effective in regulating blood glucose levels in diabetes patients and enhancing their adherence to healthy eating and adequate physical activity.14–21
We find it highly concerning that a large proportion (69.6%) of patients with active wound have never received education on diabetic foot care, especially considering that patient education significantly improves knowledge and self-care behaviors in individuals with DM. 22 This finding may be explained by the limited availability of structured hospital-based educational programs in our setting, rather than by a lack of willingness of patients to attend such programs. It is also possible that some patients perceived they had not received structured education because, although they were provided with basic information about foot care, it was not delivered within the framework of a structured, patient-centered educational process led by professionals trained in therapeutic patient education, as recommended by the (IWGDF). 23
Consequently, we believe it is crucial to intensify structured educational measures delivered by professionals specialized in DFS and patient education. Such interventions would provide patients with the necessary knowledge and follow-up support, thereby facilitating improved management of their condition.
The researcher's comparative evaluation revealed inconsistencies between the participants’ responses and observed practices pertaining to hydration, foot inspection, and appropriate footwear use. These discrepancies highlight the possibility of insufficient or improper preventative measures, potentially exacerbating disease control and increasing the risk of developing or recurring DFU. Consequently, it may be beneficial to regularly conduct observational follow-ups and educational interventions. These corrective actions could rectify patient errors in daily practices, thereby mitigating negative impacts on disease management and lessening the likelihood of DFU occurrences.
The insights gained from data extraction on the knowledge, awareness, attitudes, and practices of patients with DFS and DFU are crucial. We highly encourage the inclusion of this research approach in future studies. It serves as an effective method for developing educational interventions. By understanding the characteristics of patients with DFS and DFU using validated assessment tools, we can identify educational prevention gaps or amend incorrect practices. These findings should inform the design, promotion, and enactment of future educational interventions. Such interventions will help prevent injuries, empower patients in managing their conditions, and foster efficacious preventative measures.
The main limitation is the disparities in cultural, social, and care aspects render direct comparisons of survey results challenging, especially when the subject matter pertains to the knowledge, practices, and attitudes of patients suffering from active ulcers due to DFS. These differences notably affect the reception, interpretation, and application of received educational interventions. For instance, a similar study in South Africa 24 evidenced poor results concerning the patients’ education level, contrasting with our findings. Nonetheless, self-care practices disclosed by participants were inadequate in both scenarios. It underscores the need to establish educational programs that include follow-up periods to bolster the application of acquired self-management knowledge.
One of the primary strengths of this study is the methodological structure. Independent researchers were involved in both data collection and analysis, lending more credibility to the process. Two researchers focused on gathering data, while the other two researchers, performed the analysis. Their work was further supervised by two independent investigators, ensuring a balanced and accurate study.
Conclusion
The level of knowledge and awareness of the patients was acceptable, although patients with DFS and active DFU have educational deficiencies in the knowledge of HbA1c, despite it being considered a control parameter in their underlying disease to prevent complications.
The differences found with their behavior in terms of feet hydration deficit and the use of inappropriate footwear should motivate us to follow up to encourage adherence to the preventive measures available to address DFS.
The high percentages of patients who had not received structured education on SPD indicate that we should continue to provide structured educational interventions that are effective in improving the knowledge of patients with SPD, regardless of their level of risk.
It's essential to enhance educational activities in daily clinical practice. This will bolster the preventative measures patients take against DFU in their everyday lives.
Practice Implications
The practical implications of this study emphasize the need to intensify educational initiatives for patients with DFS, particularly focusing on self-care practices like foot inspection, hydration, and footwear use. Structured, follow-up educational interventions are crucial to correcting discrepancies between patient self-assessments and actual practices, ultimately preventing DFUs and improving disease management. Additionally, empowering patients through education about diabetes management, especially in regulating blood glucose levels, is essential to reducing the incidence and recurrence of DFUs.
Footnotes
Acknowledgements
This study has not received specific grants from commercial or non-profit public sector funding agencies. The authors declare that they have no conflict of interest concerning the research, authorship and/or publication of this article.
ORCID iDs
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
