Introduction
Diabetic foot ulcers are among the most widespread complications of diabetes and a major nursing problem, as they are difficult to treat and may lead to amputation. The key problem with diabetic ulcers is that they are the primary reason for non-traumatic amputations (Sarinnapakorn, Sunthorntepwarakul, Deerochanawong, Niramitmahapanya, & Napartivaumnuay, 2016). Negative-pressure wound therapy and hyperbaric oxygen therapy are considered to be beneficial in the management of diabetic foot ulcers (Kavitha et al., 2014).
The purpose of this study is to compare the effectiveness of the two interventions in diabetic ulcer healing and closure. The independent variables for this study are the provision of negative-pressure wound therapy or hyperbaric oxygen therapy, measured in hours. The dependent variable is the healing of ulcers, represented by a reduction in the ulcer area.
Definition of Terms
Primary intervention
The primary intervention for this study is negative-pressure wound therapy, which is a treatment method that uses an open cell structured sponge and a drain to expose the wound to sub-atmospheric pressure, promoting the healing process (Mafi, Malahias, Jordan, & Hindocha, 2014).
Comparison intervention
The comparison intervention is hyperbaric oxygen therapy, which involves placing the patient into a chamber, which is gradually pressurized with pure oxygen. The exposure of the wound to oxygen accelerates healing processes (D’Agostino & Poff, 2012).
Effectiveness
The effectiveness of the intervention is the change in the ulcer area during the follow-up period after the treatment.
Follow-up period
The follow-up period is the time after which the effect of the intervention is measured.
Hypotheses and Research Questions
Negative-pressure wound therapy is a well-established method that proved to be effective in treating diabetic foot ulcers (Zhang et al., 2014). In the case of hyperbaric oxygen therapy, less research proving its effectiveness is available. Therefore, the primary hypothesis for this study is that negative-pressure wound therapy will result in a higher reduction in the ulcer area during the follow-up period, compared to hyperbaric oxygen therapy. The secondary hypothesis is that there will be no statistically significant difference in the effectiveness of the two methods. The null hypothesis is that none of the interventions will yield statistically significant results compared to normal wound care.
The research questions that will be addressed as part of the study are as follows:
- What is the percentage reduction in the ulcer area following negative-pressure wound therapy?
- What are the cm2 and percentage reductions in the ulcer area following negative-pressure wound therapy?
- What are the cm2 and percentage reductions in the ulcer area following hyperbaric oxygen therapy?
- What is the comparative effectiveness of negative-pressure wound therapy and hyperbaric oxygen therapy, as indicated by the research outcomes?
- Were there any patients that showed no statistically significant results after the primary or alternative intervention?
- If so, what are the patient factors that could have affected the effectiveness of the chosen treatment in individual patients?
Theoretical Framework
The theoretical framework utilized in the proposed study is largely based on two studies on the effectiveness of the chosen methods in treating diabetic foot ulcers. First, a meta-analysis by Zhang et al. (2014) provides evidence in support of the primary theory. Zhang et al. (2014) show that there is a strong evidence of the effectiveness of negative-pressure wound therapy in the treatment of diabetic foot ulcers: according to the results of the studies examined, this method of therapy was associated with higher healing rates, lower recovery time, and more reduction of the ulcer area.
However, a study by Stoekenbroek et al. (2014) indicates that some evidence is available in support of the effectiveness of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers. Both studies provide a comprehensive overview of the current research regarding the two interventions; moreover, they identify the need for further research on the treatment methods, which is why they were chosen as the theoretical framework of the proposed research.
Thus, this study will seek to compare the two methods to determine their comparative effectiveness. The main concept to be explored is the reduction of ulcer size, as it is widely used to measure the efficiency of treatment (Zhang et al., 2014). For any patients that show no significant positive dynamic, the research will also try to describe the personal factors that impaired the efficiency of the applied treatment method.
Review of the Literature
As diabetic foot ulcers are a pressing nursing problem, they are extensively studied in modern research. For instance, Zhang et al. (2017) provide a useful overview of the prevalence of diabetic foot ulcers. The researchers found the global prevalence of diabetic foot ulcers to be 6.3%, with the highest prevalence rate in the United States (13%) and the lowest (1.5%) in Australia (Zhang et al., 2017).
The researchers also examine the possible risk factors for the development of diabetic foot ulcers, which is important as it helps to identify high-risk patients and begin prevention efforts to avoid the issue. The risk factors for the development of diabetic ulcers include type 2 diabetes, male sex, smoking, diabetic retinopathy, as well as older age and lower body mass index (Zhang et al., 2017). Another study that examines the prevalence of diabetic foot ulcers and provides information on the frequent complications of the disease is research by Sarinnapakorn et al. (2016).
The researchers studied diabetic foot ulcers in the context of the Rajavithi Hospital in Thailand. The study found the prevalence of diabetic foot ulcers to be 3.4%, with 2.2% of patients having a history of amputation (Sarinnapakorn et al., 2016). Overall, both studies show that diabetic foot ulcers are a prevalent problem among the patients with type II diabetes that can lead to severe complications.
There are also many studies on the treatment of diabetic foot ulcers. For example, a study by Zhang et al. (2014) describes the effectiveness of negative-pressure wound therapy in the treatment of diabetic foot ulcers, compared to other treatment methods, such as standard wound care. The researchers found that the use of negative-pressure wound therapy was associated with shorter recovery periods, higher reduction in the ulcer area, and a higher proportion of fully healed ulcers (Zhang et al., 2014).
Thus, negative-pressure wound therapy is considered to be the preferred method of treating diabetic foot ulcers. Another study by Mafi et al. (2014) supports these findings, discussing other positive aspects of negative-pressure wound therapy, such as its cost-effectiveness and its role in preventing infection. The number of recent studies examining the effectiveness of the alternative intervention, hyperbaric oxygen therapy, is relatively low. Stoekenbroek et al. (2014) provide a comprehensive systematic review of existing research on the treatment of diabetic foot ulcers with hyperbaric oxygen therapy. The researchers analyzed seven studies with an overall participant count of 376 patients.
The findings indicate a low level of evidence of the effectiveness of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers, as well as a need for further comprehensive research. Overall, the existing body of research shows more evidence of the effectiveness of negative-pressure wound therapy in the treatment of diabetic foot ulcers, compared to hyperbaric oxygen therapy. However, given the lack of high-quality primary research on hyperbaric oxygen therapy, considering this method as an alternative intervention could provide useful information regarding the comparative effectiveness of the two interventions.
Methodology
The research will use quantitative methodology. Randomized control trial is the preferred study design, as it is widely used to determine the effectiveness of clinical interventions. For instance, all studies mentioned in Stoekenbroek et al. (2014) used the RCT methodology to evaluate the effectiveness of hyperbaric oxygen therapy. Moreover, RCT will help to reduce the possible bias, as the allocation of subjects to one of the intervention groups occurs at random. In order to apply this methodology to the chosen research topic, three groups of patients are needed.
The primary intervention group will receive negative-pressure wound therapy, whereas the alternative intervention group will receive hyperbaric oxygen therapy and the control group will receive standard wound care with no add-on procedures. The overall study sample should include a minimum of 30 patients, to ensure that at least ten are in each group. The main inclusion criteria are age (50-65 years old), existing diagnosis of diabetes, and currently present diabetic foot ulcers.
Exclusion criteria include the presence of absolute contradictions to one or more interventions. Random sampling method will be used to choose the participants for the study. Data collection instruments appropriate for the study include follow-up examinations and nurse surveys. Data should be collected weekly after each follow-up examination. The researchers will measure the ulcer area, whereas the nurses will be asked to fill in surveys specifying their observations and the number of hours of treatment provided.
Nurses’ observations will be used to determine individual patient factors that could impair the treatment outcomes. For the protection of human subjects, informed consent will be obtained before the beginning of the research. The informed consent should indicate that the patient is aware of the goals of the study, as well as the possible side effects of the treatment, and agrees to comply with the follow-up scheme.
Data Analysis
The data on the size of ulcers and hours of treatment received will be analyzed using descriptive statistics, as this will assist in comparing the interventions easily. Moreover, regression analysis for each intervention should be performed to determine the significance of positive correlation. The results of data analysis will be presented in tables (descriptive statistics) and graphs (regression analysis), which will allow comparing the effectiveness of the interventions. The findings will also be presented in text form to provide all the necessary explanations and allow the results to be used in secondary research.
Applicability to Nursing
Diabetic foot ulcers present a significant nursing problem due to their high prevalence and severe consequences, such as amputation. Despite the fact that both negative-pressure wound therapy and hyperbaric oxygen therapy are used as add-on treatments in patients with diabetic foot ulcers, there is a lack of current research comparing the effectiveness of the two methods. The results of this research could be used to inform the use of add-on treatments in the management of diabetic foot ulcers, and will thus be beneficial to several areas of nursing, including wound care, hyperbaric nursing, geriatric nursing, and clinical nursing.
References
D’Agostino, D., & Poff, A. (2012). Hyperbaric oxygen therapy. The South-African Journal of Natural Medicine, 104(1), 12-14.
Kavitha, K. V., Tiwari, S., Purandare, V. B., Khedkar, S., Bhosale, S. S., & Unnikrishnan, A. G. (2014). Choice of wound care in diabetic foot ulcer: A practical approach. World Journal of Diabetes, 5(4), 546-556.
Mafi, R., Malahias, M., Jordan, D. J., & Hindocha, S. (2014). The evidence-based principles of negative pressure wound therapy (NPWT) dressing applications: A review of the literature. International Journal of Infection Control, 10(2), 1-8.
Sarinnapakorn, V., Sunthorntepwarakul, T., Deerochanawong, C., Niramitmahapanya, S., & Napartivaumnuay, N. (2016). Prevalence of diabetic foot ulcers and risk classifications in type 2 diabetes mellitus patients at Rajavithi Hospital. Journal of the Medical Association of Thailand, 99(2), 99-105.
Stoekenbroek, R. M., Santema, T. B., Legemate, D. A., Ubbink, D. T., Van den Brink, A., & Koelemay, M. J. W. (2014). Hyperbaric oxygen for the treatment of diabetic foot ulcers: A systematic review. European Journal of Vascular and Endovascular Surgery, 47(6), 647-655.
Zhang, J., Hu, Z. C., Chen, D., Guo, D., Zhu, J. Y., & Tang, B. (2014). Effectiveness and safety of negative-pressure wound therapy for diabetic foot ulcers: A meta-analysis. Plastic and Reconstructive Surgery, 134(1), 141-151.
Zhang, P., Lu, J., Jing, Y., Tang, S., Zhu, D., & Bi, Y. (2017). Global epidemiology of diabetic foot ulceration: A systematic review and meta-analysis. Annals of Medicine, 49(2), 106-116.