View clinical trials related to Diabetic Neuropathies.
Filter by:Type 2 DM subjects having numbness, tingling and paresthesia in hands and feet (neuropathy) will be recruited. Screening of neuropathy will be done by Michigan screening instrument. This will be followed by nerve conduction studies. Specific blood parameters will also be checked. The subjects will then be divided into four treatment arms. Three groups will receive single drug and the fourth one will receive all the three drugs. These will be given for four months. Follow up will be done every month. At the end of four months, they will be assessed for any improvement in neuropathy by using Michigan neuropathy instrument and nerve conduction studies. Blood parameters will also be measured again.
Diabetic peripheral neuropathy (DPN) occurs due to long standing hyperglycemia and associated metabolic derangements. Cognitive impairment is a common complication in diabetes mellitus. It is associated with a faster rate of cognitive decline.
Compare Axon Therapy plus conventional medical management (CMM) to Sham plus CMM in reducing neuropathic pain in patients with painful diabetic neuropathy (PDM).
The purpose of this study is to evaluate the efficacy and safety of intramuscular (IM) administration of Engensis on pain in participants with painful diabetic peripheral neuropathy (DPN) in the feet and lower legs, as compared to Placebo, as a second Phase 3, well controlled study, sufficient in supporting the efficacy and safety of Engensis.
This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective, randomized comparison of the two treatments.
The objectives of the MEDIAN study are to evaluate the short-term and long-term safety and nutritional benefits of Metanx® versus placebo in subjects with mild to moderate diabetic peripheral neuropathy (DPN). Short-term effects will be evaluated during the first 16 weeks of treatment, and long-term effects will be evaluated over the duration of a 48 week treatment period.
Type 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and early diabetes affects a considerably larger but unknown population group. At the current time there is no effective therapy to completely prevent, or reverse neuropathy associated with IGR and this represents a considerable challenge in rehabilitation. There is a particularly strong incentive to prevent IGT and related complications from advancing to DM2. IGR is a growing problem among all older adults and its strong association with many functional limitations, particularly mobility limitations, is not always recognized, even though diabetes-related disability occurs in up to 2/3 of older adults with diabetes and is associated with dependency, poor quality of life, and increased acute and long-term care utilization. Autonomic dysfunction is a significant problem in subjects with IGT. The Preliminary Data shows that over 90% of subjects with IGT have an abnormal score on questionnaires about autonomic symptoms such as lightheadedness, dry mouth or dry eyes, pale or blue feet, feet that are colder than the rest of the body, decreased sweating in the feet or increased sweating in the hands, nausea or bloating after eating, persistent diarrhea or constipation, or leaking of urine. In addition, patients with IGR have impaired balance control. These factors can increase the risk of falls in affected subjects. A non-randomized and non-controlled study showed that a diet and exercise intervention in patients with diabetes led to an overall improvement in autonomic function. Furthermore, it was shown that standing balance can be improved with a balance intervention program. However, there are no published studies that assess the effect of an intense physical activity intervention on autonomic function in IGR related neuropathy. This study will test an aerobic exercise and balance intervention in participants with IGR. The investigators will examine if an individually tailored, carefully monitored, Diet, Physical Activity, and Balance Enhancement Program (DPAEP) can improve autonomic function and balance control when compared to patients who receive standard care. Improving balance control and autonomic function can decrease the risk of falls and have a significant effect on the health of participants. The research is also significant because it will test subjects either before they become diabetic, or at an early stage in their diabetes, thus enhancing the chance of reversing the autonomic neuropathy or balance impairment. Furthermore, the study is designed to test whether improvement in autonomic function and balance is associated with improvement in clinical outcomes, quality of life, and the metabolic state of participants. Thus, the proposed interventions are likely to have a real life impact on participants and their health.
The purpose of this study is to evaluate the efficacy of the NormaTec PCD, a non-invasive pneumatic compression device with the patented peristaltic pulse pneumatic waveform, in the treatment of Diabetic Peripheral Neuropathy (DPN). The study will compare treatment with a NormaTec PCD and a sham device to assess whether the NormaTec PCD improves the signs and symptoms of DPN.
Rationale: Diabetic neuropathy is one of the most common complications of Diabetes Mellitus (DM). Pain is a common symptom of diabetic neuropathy, affecting 11-34% of patients suffering form DM. The burden of disease of painful diabetic polyneuropathy (PDP) is high for both the patient and society, due to significant pain levels, frequent co-morbidity, polypharmacy and significant health resource use. Spinal cord stimulation (SCS) has been used for over 30 years to treat neuropathic pain. Several small clinical studies have shown a beneficial effect of SCS on pain in PDP. Objective: The primary objective of this study is to investigate whether SCS leads to clinically relevant (≥50%) pain relief in patients with moderate-to-severe PDP in the lower limbs after 6 months of treatment. Secondary objectives to investigate 1) the effect of SCS on health related quality of life in PDP; 2) the effect of SCS on the quality of sleep in PDP; 3) the effect of SCS on mood in PDP; 4) the effect of SCS on blood glucose control in PDP; 5) the effect of SCS on large and small nerve fibre functions in PDP; 6) identifying predictive factors for success of SCS treatment of PDP; after 6 months 7) the effect of SCS on small fibre loss and regeneration in PDP; and 8) costs, cost-utility and cost-effectiveness after 12 months of treatment. Study design: the study is a multi centre randomized controlled trial. Study population: Patients suffering from moderate-to-severe PDP in the lower limbs due to diabetes mellitus type 1 or type 2 as diagnosed by clinical symptoms (glove and stocking distribution). Intervention: patients assigned to group 1 will receive spinal cord stimulation (SCS) and/or best (drug) treatment as possible, patients assigned to group 2 will receive best (drug) treatment as possible. Main study parameters/endpoints: The main study parameter will be the mean pain intensity and/or maximal pain intensity during daytime and/or during night time as measured on a weighted NRS and/or a PGIC for pain and sleep measured on a 7-point Likert scale, after 6 months of treatment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: SCS related risks include: lead migration (14%), lead breakage (7%), implanted pulse generator migration (1%), loss of therapeutic effect, lost or unpleasant paresthesias (12%), infection or wound breakdown (10%), Pain at IPG incision site (12%), IPG pocket fluid collection (5%). Treatment-as-usual related risks are related to the medication used and do not increase due to participation in this study.
The primary objective of this study is to identify whether cardiovascular complication rates are lower in patients who participate in managed diabetes care, in comparison to provincial and national rates. This study will involve an electronic medical record (EMR) chart audit, augmented by a manual review of hospital and other pertinent medical records, as necessary.