Research Proposal for Diabetic Foot Ulcer

Research Proposal for Diabetic Foot Ulcer - Type 2 - The effectiveness of Honey dressing therapy versus iodine dressing therapy in the management of neuropathic diabetic foot ulcers Table of Contents 1 Abstract4 2 Introduction5 3 Literature Review7 * Studies related to foot ulcer7 * Studies related to honey and iodine dressing therapies9 * Qualities of life of DFU patients13 4 Aim15 5 Objectives15 6 Hypotheses15 7 Conceptual Framework15 8 Proposed Research Focus/Justification for the Study16 9 Proposed Methodology17 * Setting17 * Research Design17 * Sampling Procedure17 * Search Strategy17 * Sampling Criteria18 * Inclusion18 * Exclusion18 * Sampling Technique18 10 Data Collection18 Instruments19 Data Analysis19 Pilot Study20 Variables20 * Independent Variables20 * Dependent Variables20 Projected Outcomes20 Ethical Considerations21 Limitation References Abstract Diabetic neuropathy is the common factor in almost 90% of diabetic foot ulcers. Nerve damage in diabetes affects the motor, sensory, and autonomic fibers. Motor neuropathy causes muscle weakness, atrophy, and paresis. Sensory neuropathy leads to loss of the protective sensation of pain, pressure, and heat. Autonomic dysfunction causes vasodilation and decreased sweating, resulting in a loss of skin integrity, providing a site vulnerable to microbial infection. The aim of the proposed study is to determine which of the two therapies; honey dressing versus iodine dressing is more effective in treating Diabetic Foot Ulcers in terms of measuring the percentage of improvement of healing, cost and the participants’ quality of life. Both qualitative and quantitative studies will be conducted. The study will be performed in various local Podiatry clinics setting for 12 months from September 2018 till September. Patients with diabetes mellitus (DM) type 2 and neuropathic foot ulcers will be recruited and following informed consent will be randomly assigned to group A (Honey dressing) or group B (iodine dressing) followed by daily dressing changes and a standardized offloading device will be used. The time to heal, quality of life and the accumulative costs of each intervention will be recorded up to 12 months which will be the end point of the study. The end point of the study month 12 at that time we will measure all the ulcers and describe the ulcers as a percentage healing from the baseline to the end of the study, the healing will be measurement from the baseline of healing. Inferential statistics will be done to analyze the quantitative data. The statistical analysis will be using the chi-square, Friedman, and Dunn tests with a significance level of < 5% (P < 0.05). Thematic analysis will be used to analyze the qualitative data. A purposive sample from the main study (both groups) will be selected for interview in order to gain insight into the patient’s experiences of each dressing in relation to quality of life.Key Words: Honey dressing, Iodine dressing and Diabetic Foot Ulcers, diabetes type 2, age.  Introduction Diabetes is the major cause of non-traumatic lower extremity amputations in developed countries. This is due to untreated foot ulcers and they exist as a result of other complications caused by diabetes such as peripheral arterial disease (PAD), peripheral neuropathy and trauma to the foot. The neuropathy is caused by nerve damage that reduces pain and temperature sensation at the foot. The decline of sensation does not allow major traumas to be noticed allowing ulcers to develop in areas that have pressure. Besides sensory loss, other problems such as muscle weakness and motor deficits are as a result of nerve damage. Another major factor for the development of foot ulcer is peripheral arterial disease which is caused blockages in the arteries that reduces blood flow to the feet. Due to reduced blood flow to the feet, wounds are unable to heal because of reduced oxygen, white blood cells and nutrients which are transported by blood. The combination of peripheral neuropathy, insufficient blood flow to the feet and a change in foot mechanics makes diabetes patients vulnerable to foot ulcers with the inability to heal the wounds. Diabetes is a common disease which affects an approximate population of 25 million people across the world. 6.9% of them have a foot ulcer throughout their life (Amin and Doupis, 2016). Statistics show that an approximately 90,000 amputations on diabetes are done every year and 80% are as a result of ulcerations (Alexiadou, and Doupis, 2012). The onset of Type 2 Diabetes Mellitus (DM) are the result of a combination of environmental, genetic, and socio-economic factors, specifically systemic and metabolic dysfunctions, insulin resistance, leading to the body’s inability to break down glucose, effectuating hyperglycemia (Olokoba, Olusegun & Olokoba, 2012). A significant complication of diabetes is the risk of foot ulceration.  Whilst peripheral neuropathy is one of the main causes of foot ulceration, repetitive trauma, excessive pressure on the plantar regions of the foot can also contribute to the formation of a foot ulcer (Singh, Armstrong & Lipsky, 2005). The effects of these foot ulcers impact on comfort, mobility and limiting joint movements at the ankle due nerve damage. Further negative effects of foot ulcers cannot be underestimated as they can severely restrict mobility, lower a person’s quality of life Macioch et al., (2017) and has significant socioeconomic impact (Alexiadou & Doupis, 2012).  According to Lipsky (2004), the treatment of diabetic foot ulcer involves debridement which includes the removal of all the affected tissue and prescription of oral antibiotics. He further stated that it also involves metabolic control and treatment of optimal diabetes control if necessary insulin can be used. He concluded that ulcer treatment and management involve regular wound debridement, inspection and absorbent dressings. According to Jeffcoate et al. (2016), diabetic foot ulcers are commonly found in people with diabetes. However, there proves to be a lack of evidence base available to assist people who have both diabetes and consequently foot ulcers, preventing effective management of the symptoms. This highlights how there is a gap in the research which needs to be addressed to explore ways in which foot ulcers, associated with type 2 diabetes, can be managed to improve patients’ quality of life. Further, a recent survey conducted by the Diabetes UK has found that over 30% of people fail to recognize how the development of foot ulcers is due to diabetes-induced complications, which can lead to amputation and possible death (Wang et al., 2016; Zimny, Schatz, & Pfohl, 2004). This can be attributed to lack of awareness of the relationship between diabetes and foot ulcers among the UK population (Diabetes UK, 2013) and can be a factor in delayed presentation with the ulcer and therefore delayed treatment and healing. There are a number of topical treatments that have been used to treat and manage DFUs. They include acidic treatments, antibiotics, debridement, off-loading and dressings (Alavi et al., 2014). However, the last three are the most commonly used within podiatry clinics. Debridement entails the removal of nonviable and infected tissues. This promotes wound healing and it can be performed through the use of various tools such as surgical blades, ultrasonic and scissors (Leaper, 2002). Offloading is another method of reducing pressure on affected areas to promote healing. There are a number of offloading methods but Total Contact Casting (TCC) is considered to be the gold standard. Katz et al. (2005) identified a number of studies that demonstrate that TCCs help in reducing pressure at areas of ulceration by more than 85% (Katz et al., 2005). Dressings are also another method that has been used by physicians to treat DFUs. The common dressing therapy that is commonly used is honey dressing. Clinicians have been using this type of dressing to treat different types of conditions for centuries. Honey dressing provides a moist micro-environment that promotes tissue formation accelerating wound healing (Molan, 2006). As stated by Jeffcoate et al., (2016) there is a lack of high-quality evidence-research based for the gold standard “treatment choice” in both the prevention and management of Foot ulcers nor is there evidence as to how increasing awareness for patients can reduce the risk of ulceration or re-ulceration. However, dressings are one of the important components in the management Diabetic neuropathic foot ulceration. Hence the purpose of the literature review is to explore the factors that lead to foot ulceration to explore the effectiveness of two types of foot ulcer dressing and factors that influence quality of life as well as the effectiveness of the two types of dressings in managing the DFUs. Literature Review Search Strategy To find the relevant literature, various databases were examined. They include; Google Scholar, Cochrane Library, PubMed, Cumulative Index for Nursing & Allied Health and Clinical Evidence. The following key terms were used: diabetic foot ulcers, honey dressing, wound treatment, wound management. The search was restricted to dates from 1999 to 2018, English and full text. The results were categorised into: * Studies related to the development of diabetic neuropathic foot ulcer. * Studies related to honey and iodine dressing therapies. * Factors that influence the Quality of life of DFU patients. Various studies have indicated multiple risk factors for the development of diabetic foot ulcers. They include, gender, age, foot deformity, high Body Mass Index, infections, peripheral vascular disease, peripheral neuropathy, duration of diabetes among others. Although the available literature points to the same direction that these risk factors contribute to diabetic foot ulcers, up to date neuropathic abnormalities and ischemic are the major causes of DFU. Of all the diabetic foot ulcers 10% caused by ischemic while 90% are as a result of neuropathy abnormalities. Over the last few years, incidences of neuro-ischemic ulcers have increased and are the most common type of ulcers experienced in most diabetic clinics in the world. In their article, Ameersing, Balasankar and Abida (2015), discuss the various aspects of diabetic foots from their epidemiology to the role of footwear in diabetic foot ulcers causation and prevention. The authors address the types diabetic foots in regard to the cause. The article provides other deformities that the foot may develop beside ulcers such as Charcot foot. It provides a detailed discussion of the causes, risk factors, pathophysiology and types of diabetic foot ulcers (Diabetic neuroischemic foot, diabetic neuropathic foot and diabetic Charcot foot) (Ameersing, Balasankar & Abida, 2015). Conversely, the article provides an alternative method for the prevention of diabetic foot ulcer by emphasizing on the significance of the customized therapeutic footwear for the various types. The authors assert that, diabetic patients should pay attention to preventing DFU by choosing appropriate footwear. They further state that diabetic foot patients wearing footwear without protective sensations increases stress on the foot. Therefore, appropriate footwear plays a significant role in reducing stress preventing the risks of ulcerations. The authors also discuss the textile materials that plays an important role in wound healing since most footwear is made of these materials. This knowledge about diabetic foot ulcer and footwear plays an important role in the maintaining healthy feet and preventing of adverse complications (Ameersing, Balasankar & Abida, 2015). In the quest to determine the effectiveness of honey dressing, Shukrimi (2008) conducted a prospective study to compare the effectiveness of honey dressing and Povidone Iodine dressing for Wagner Type II Diabetic Foot Ulcers. Surgical debridement and antibiotics were prescribed for all patients. The study used 30 patients aged between 31-65 years with the mean year of 52.1 years. The average healing time for the honey group was 14.4 days (7-26 days) as compared to 15.4 days in the standard dressing therapy group (9-36 days). The study concluded that there was no significant difference in ulcer healing in both groups. However, the results demonstrated that honey dressing therapy is safe for Wagner grade-II diabetic foot ulcers (Shukrimi, 2008). In another study, Hussein et al., 2014 conducted a similar study to compare the effectiveness of honey dressing in diabetic foot ulcer healing with povidone iodine dressing. The study used 320 patients who were divided into two groups consisting of 160 patients each. Povidone iodine dressing was used in one group while honey therapy on the other group. The patients were monitored on a weekly basis to assess their time recovery. Surgical debridement followed by daily dressing was done for each patient. The results showed that recovery time for honey dressing in the first 3 weeks was 56.2% and 44.6% in the 4-6 weeks. In Povidone dressing, in the first 3 weeks recovery was 43.8% and 56.6% in 4-6 weeks (Hussein, et al., 2001). It was found that honey had a faster recovery rate as compared to povidone iodine dressing. Consequently, it was established that honey was more effective in wound healing. The study conquered with Shukrimi’s early study which concluded that honey dressing is a safe and effective alternative in diabetic foot ulcers. However, this study concluded that more research is required to explore the effectiveness of honey in other wounds as well as validate the existing results. Another group of researchers (Alam et al.,2014) conducted a systematic review to demonstrate how and why honey should be considered as the best alternative in diabetic wound management. The review also provided scientific evidences which supports this traditional therapy in the treatment of diabetic wounds. They reviewed various aspects ranging from the association of honey, its effects to the role of nutrients in honey on diabetic wounds. They also provided clinical evidences supporting the use of honey in wound healing. The review concluded that honey is a safe and suitable alternative with improved outcomes in diabetic wound healing (Alam et al., 2014). Further to the study by Alam et al (2014), da Silva et al. (2015), conducted a systematic review which described the chemical characteristics of honey elements, their quality when heated or stored for long periods as well as the parameters that can be used to identify the elements and their quality. Some of the chemical characteristics of the elements that were examined include sugars, organic acids, proteins, minerals, vitamins, amino acids, enzymes and other compounds that are present in honey. The review discussed the stability of these compounds in regard to various reactions such as heating and long storage periods. These helps in understanding the behavior which may compromise the quality of honey. This review plays a significant role in choosing the best quality of honey to be used in the experiment. For best results, best quality products are to be used. There are instances where honey does not heal the wounds fast, to eliminate the benefit of doubt on the quality of honey used, the best quality has to be used (da Silva et al., 2015). In 2005 Singh, Armstrong and Lipsky conducted a systematic review on the efficacy of the advocated methods for the prevention of diabetic foot ulcers. In their review, they addressed various protocols beginning with patient screening to identify the risk factors. Theirs was not just a review but also a framework development for the prevention of diabetic foot ulcers. In their review they also addressed the cost-effectiveness of the methods. They found out that the average annual costs for the treatment in 2001 was “$9,306 for an uninfected diabetic foot ulcer, $24,582 for an infected foot ulcer, and $45,579 for a foot ulcer with osteomyelitis” (Singh, Armstrong & Lipsky, 2005). In general, the review provides a holistic model for diabetic foot ulcer treatment. In 2008, Visavadia, Honeysett and Danford conducted a study in the UK on Manuka honey dressing. This was as a result of methicillin-resistant Staphylococcus aereus (MRSA) wound infection which was becoming more difficult as drug resistance was also increasing in the community. Manuka honey dressing has been used as a non-antibiotic therapy for the management of chronic wounds. The studied clinic affirmed that they have successfully been using honey dressing in their wound care clinic for more than a year and there were remarkable results (Visavadia, Honeysett & Danford, 2008). As a result of increasing antibiotic resistance and interest in natural therapies in wound treatment and management. Stephen-Haynes (2004) conducted a study on the use of honey and its healing properties. Much of the available literature focuses on the antibacterial properties of honey. Some of these properties include stimulation of new tissue growth and promotion of epithelialization. This claimed properties of honey proves to be valuable to the treatment and management of honey. The study evaluated the effectiveness of honey dressing in a number of wounds. The study concluded that although there is a need for further study, honey dressing is valuable in wound treatment and management (Stephen-Haynes, 2004). In 2016 Tsang et al. conducted a prospective randomised pilot study to compare the effectiveness of nanocrystalline silver (nAg), manuka homey (MH) and conventional dressing therapies in diabetic foot ulcer healing. The study used 31 participants who were grouped into three groups (11 in nAg group, 10 in MH group and 10 in the conventional dressing therapies group). Only patients diagnosed with type 2 diabetes were enrolled in the study. There was wound cleaning, debridement and dressing according to the group. The results showed that the proportions of ulcer healing were 81.8%, 50% and 40% in nAg, MH and conventional dressing respectively (Tsang et al., 2016). They also showed that the reduction of ulcer size was higher in nAg group followed by MH group and lastly in conventional dressing. The study concluded that nAg is more effective than MH and conventional dressing in the treatment of diabetic foot ulcer. In 2018, Nuwa et al., conducted a systematic review to determine the effectiveness of honey dressing in diabetic foot ulcer healing. The reviewed articles were searched on 7 electronic databases. The used databases include CINAHL, Google Scholar, Ebsco, Proquest, Science Direct, and Sage Journal. The search was limited to articles that were published in English and between 2000 and 2016. The results show that 7 out of 10 articles addressed wound management through honey using RCT design. The overall results of the study demonstrate that honey is a good alternative in diabetic foot ulcer treatment. In conclusion, the study concluded that to validate these results, more randomised clinical trials are required and in comparison, with other dressing therapies (Nuwa et al, 2018). Nasiriziba et al., (2015), conducted a cross-sectional study which investigated the factors that are associated with the quality of life of DFU patients. 60 patients (32 males and 28 females) were enrolled in the study and they were supposed to answer 29 questions in regard to their daily life. The questionnaire addressed the following aspects; physical health, concern about the wound, negative emotions, wound caring, enjoying life and daily activities dependence. The findings from the study showed that DFU has a significant impact on the quality of life of patients. One factor affecting the quality of life is the location of the ulcer which affects the various dimensions such as negative emotions, physical health, wound care and enjoying life. The study identified various factors of DFU that affects the level of quality of life of patients. These factors include the number of ulcers, smoking, marital status, job and many more (Nasiriziba et al., 2015). In 2015, Jull et al., conducted a review on honey as a topical treatment for wounds. They reviewed previous studies that have compared the efficacy of honey in comparison with other alternative wound dressings. The findings of this review showed that there is low quality evidence in some studies supporting the claims that honey heals wounds more quickly than the alternative conventional dressings such as SSD. However, other studies demonstrated that honey healed post-surgical wounds more quickly than alternative dressings. Moreover, the effects of honey in comparison with the conventional alternative dressings were unclear in venous leg ulcers, diabetic foot ulcers, minor acute wounds, mixed chronic wounds and Leishmaniasis (Jull et al., 2015). The authors concluded that it is difficult to make conclusions in regard to the effects of honey in the treatment and management of wounds due to various factors such as low quality of evidence and heterogeneous nature of patient populations. Honey appears to be effective in healing partial thickness burns and post-surgical wounds than the conventional therapies. Due to the low quality of evidence, the review calls for further explorations in this area to provide quality evidence that will help in drawing conclusions. According to (Goodridge Trepman & Embil 2005), the quality of life is worse among diabetic patients than in those individuals who are not suffering from the condition. Diabetic foot ulcers reduce the mobility of patients affecting their daily activities which has a positive relationship with the quality of life (Goodridge Trepman & Embil, 2005). From the findings of their study, DFU have a significant impact to the psychological and social aspects of the patients. The participation in social activities is reduced, there is increased family tensions, financial problems as well as limited employment. Moreover, these findings confirm results from previous studies which assert that DFU has a negative effect on the physical, psychological and social aspects of people. The authors conclude that disease-specific surveys will play a significant role in the evaluation of health-related quality of life in ulcer healing, the impact of different treatment and management therapies on the quality of life and the relationship between specific qualities of life, compliance of the patients as well as effectiveness of the treatment therapy (Goodridge Trepman & Embil, 2005). Findings from the above systematic review are not definitive. Furthermore, the findings only suggest that honey dressing may be effective in speeding up the treatment period as compared to other dressing therapy. Therefore, the need for high-quality researches to clarify the efficacy of honey dressing in DFU treatment and management. Summary The available literature demonstrates that the reason why foot ulcers are on the rise is because patients are in denial of their conditions and fail to take full responsibility of their well-being. However, these studies have demonstrated that DFUs have adverse impact on patients and effective management of foot re...