Significant hepatic disease as judged by the clinical investigator (that might cause neuropathy unrelated to diabetes).Documented DVT within the previous 3 months (since an acute DVT is a contraindication for Pneumatic Medicine treatment).Medication for glucose control changed within the previous 3 months (to avoid confounding the results of the study). Medication for neuropathic pain initiated within the previous 3 months (to avoid confounding the results of the study).Neuropathy documented to be caused by something other than diabetes.Unlikely to be compliant with the research protocol as judged by the clinical investigator.Abnormal peroneal motor nerve conduction study where CMAP amplitude is less than 4 mV bilaterally.Patient diagnosed with distal symmetric polyneuropathy (DPN) attributable to diabetes.Patient diagnosed with type 1 or type 2 diabetes.In this prospective, randomized, double-blind study, subjects will be randomly placed in one of two groups: a control group using a sham NormaTec PCD ("placebo") and an experimental group using a NormaTec PCD. numbness, pain, and tingling in the legs) and the underlying functioning of the nerves in the legs (as determined by sensory perception assessments and Nerve Conduction Studies testing). The goal of this research project is to assess the effectiveness of a non-invasive, patented peristaltic pulse pneumatic compression device (the NormaTec PCD) in a home treatment program to improve the symptoms of DPN (e.g. However, to date there are no medications currently approved by the Food and Drug Administration to treat DPN. DPN is an important risk factor for the development of foot ulceration, one of the most common causes for hospital admissions and lower-limb amputations among diabetic patients. Why Should I Register and Submit Results?ĭiabetes frequently leads to decreased sensation in the legs caused by diabetic peripheral neuropathy (DPN).
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