A Phase III, Double-Blinded, Randomized, Placebo-Controlled, Multicenter Superiority Trial to Assess the VM202 in Painful Diabetic Peripheral Neuropathy Introduction Diabetic peripheral neuropathy (DPN) is the most common type of diabetic neuropathy (NIH, 2009). Chronically high levels of blood sugar lead to nerve damage not only in the extremities, but also in other parts of the bodies. This damage occurs in an approximate 60% to 70% of all diabetic patients, eventually, developing into peripheral neuropathy (WebMD,2013). These damaged nerves have trouble effectively transfer messages between the brain and other parts of the body, which means DNP patients are prone to unaware the sores or injuries in the feet until infected. Also, this form of neuropathy patients has a high risk of pain and autonomic dysfunction. DPN is a progressive, poorly reversible or irreversible complication and no approved drugs could be used to reverse or halt the progression of it. It is the most frequent reason for seeking medical concerns and …show more content…
The Shapiro-Wilk statistical test is used to assess the normal distribution of the pain intensity before conducting subsequent statistical tests. Data analysis is performed using mixed models with two-sided, with a type I error set as .05. Concerning the primary objective, the comparison between randomized groups will be performed using ANOVA with a baseline score as a covariate. The correlation between baseline and follow-up scores is also calculated (Vickers, 2001). In the secondary analysis, chi-square is carried out to express the frequencies of adverse effects and response rate. Also, A paired student test is suggested to evaluate the pain reduction within the two groups. Sensitivity analysis will be proposed to assess the robustness of the data based on the pattern-mixture and selection
Adequate pain assessment is essential for measuring the efficacy of treatment in clinical practice, provide patient with target pain treatment, and avoid the high number of non-responders.15 Clinically, valuable pain assessment would associate certain signs and symptoms that comprise the pain phenotype with underlying mechanisms.15 Methods such as quantitative sensory testing, functional imaging, skin biopsies and genetic screening are assessment tools provide valuable information regarding the neurobiology of pain.15 However, these tools are expensive, require technical expertise and not suitable for routine assessment of a patient’s pain.15 Therefore, the purpose of this study is to establish biopsychosocial pain profiling of multiethnic
Neuropathy – this Nerve Damage is caused by Sugar present in high levels which is capable of injuring the walls of the tiny capillaries within the blood vessels that nourish your nerves specifically in your legs. Resulting in feeling such as numbness, burning, tingling staring at the tips of the toes or fingers is usually felt as pain and gradually spreads upward. When this is left untreated
Diabetes Mellitus Type 2 with Diabetic Peripheral Neuropathy, Diagnostic Code 250.60, E11.42 – “ Stoke Risk 2-4 Times Higher than Non-diabetics” [5]
Most of the patients that I have encountered are diagnosed with Diabetic Neuropathy (DN). Diabetic Neuropathy is a brought about by a complication of Type 1 and Type 2 Diabetes. In 2012, there are about 29.1 million Americans, or 9.3% of the population, had diabetes (American Diabetes Association [ADA], 2016). Due to its increase
My patient has idiopathic progressive neuropathy. This means that the cause of his neuropathy cannot be determined and is developing gradually. Nerve damage is interfering with the functioning of the peripheral nervous system (PNS). Damaged nerves can occur in the brain and spinal cord and affect how the peripheral nervous system communicates with the rest of the body, it sends incorrect signals which can be a risk factor for falls. He is not a diabetic which is one of many causes of neuropathy.
Globally, The number of patients with diabetes is increasing rapidly. By the year 2035, the number of people with diabetes worldwide is expected to rise to 592 million (IDF ATLAS 20131). Diabetic peripheral neuropathy (DPN) is a common microvascular complication of diabetes and a leading cause to amputations in hospitals (Boulton 20052). The prevalence of DPN is estimated to be 50-60% (Sandireddy R 20143). The pain associated with DPN can affect the patient quality of life (QOL). It affects their sleep, lifestyle, work and even can cause or be associated with depression (Jensen MP 20074). It is not well understood whether the mechanism behind peripheral neuropathy with diabetes is hyperglycemia or other insulting pathophysiological mechanism like proinflamatory immune mediators (Herder C 20135, Goh S-Y 20086). One of the possible mechanisms is the demyelination of the small C fiber, this is the leading cause behind the pain sensation with
First, we will talk about Peripheral neuropathy which is a medical term used to describe a whole series of disorders resulting from damage to the body's peripheral nervous system( Alexiadou and Doupis, 2012). According to research, Diabetic neuropathy is the common factor in almost 90% of diabetic foot ulcers ( Alexiadou and Doupis, 2012). Because even a slightly high blood sugar level can causes damage of some nerves. It will affected
Diabetes affects every system in the body, including the nervous and circulatory system, and immune system. Dysfunction in these three systems set up a catch-22 situation that can have serious consequences. A diabetic may have neuropathy, or nerve death in the feet. This means that your feet are not very sensitive, and he may not notice if he has stepped on something sharp, or have an ulcer on the foot. Poor circulation means he does not have enough blood to help the wound heal, and if infection sets in the wound, can
Management of diabetic neuropathy will reduce the symptoms of the pain and improve the quality of life of an individual. However, it important that clinicians are thorough in clinical evaluation of patients to be aware of the indirect warnings of disease process (Cox, DeGraauw, & Klein, 2016). One cannot design a treatment plan, until a complete history and physical examination are necessary. Armed with extensive information about diabetes, signs, complications, and cognizance to make appropriate therapeutic intervention then it can be anticipated that we can take account of any possibility of differential diagnosis, so as to efficiently classify the patient for treatment or to direct patients to the proper healthcare provider, thereby minimizing and preventing mortality and morbidity (Mathers, 2012, p. 216).
While there are a variety of medical conditions which go hand in hand with peripheral neuropathy, diabetes is the most common. When nerves which transmit pain and other signals to the brain are damaged due to regularly high blood sugar levels, diabetic neuropathy can occur.
Eligible patients are at ≥ 18 years to ≤ 75 years who diagnosis of painful diabetic peripheral neuropathy in both lower extremities. Patients who suffer from lower extremity pain for at least 6 months and had been given a primary diagnosis of PDPN. Patient eligibility required a score of ≥4cm on VAS at screening and a score of ≥3 on MNSI.
Foot problems are a big risk in diabetics therefore diabetic patients must constantly monitor their feet or face severe consequences, including amputation. With a diabetic foot, a wound as small as a blister from wearing a shoe that's too tight can cause a lot of damage. Because diabetes decreases blood flow, injuries are slow to heal as new blood often doesn’t flow freely to the injury. When wounds do not heal in a timely fashion, they are at risk for infection meaning that infections in the feet of diabetic patients spread quickly. If you have diabetes, you should inspect your feet every day. Look for puncture wounds, bruises, pressure areas, redness, warmth, blisters, ulcers, scratches,
A t-test and an OLS regression were used to determine the differences of pain rating in the past seven days between males and females. The t-test output indicates a significant difference of pain score between females and males, t (2130) = 5.8629, p<0.001.
This paper will focus on a common, though not inevitable, side effect of Diabetes – Diabetic Foot Ulcers. An ulcer is a wound or sore that fails to heal correctly or at all. In well-developed countries, it is estimated that the annual incidence of foot ulcers in diabetic patients is 2%. However, in less-developed countries, where diabetes is more common, it is estimated to be much higher (Boulton 2005).
Diabetic peripheral neuropathy (DNP), also know as Neuropathy nerve damage. “Diabetes can impair blood flow to your feet and cause nerve damage” (Castro 180). High blood sugar can injure nerve fibers throughout your body, but diabetic neuropathy most often damages nerves in legs and feet. “ Enigmatically, recent reports have described that long-term tight glycemic control may be major risk factor for the development of diabetic neuropathy” (Zhang, et al. 1). Diabetic neuropathy can also affects the eyes, retinopathy, increasing the risk for glaucoma and blindness. Physicians recommend eye exams every six months to one year. The eyes must be checked often as vision can deteriorate quickly in patients with diabetes. A person with diabetes may not be aware of a wound or injury to their foot due to a decreased sensation in their feet, a condition called diabetic neuropathy. Therefore, great care must be taken to inspect the feet everyday. Neuropathy is a chronic condition, which will get worst over the time. Been diagnosed with neuropathy can change a patients life; this can turn into a chronic disease that will be treated with adequate medication, maintaining low blood sugars, doing self-examinations of the feet to prevent any further complications and visiting the physician as directed to do routine check ups.