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Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch: PATHON.
Silva SY, Rueda LC, Marquez G, Lopez M, Smith D, Calderon CA, Castillo JC, Matute J, Rueda-Clausen CF, Orduz A, Silva FA, Kampeerapappun P, Bhide M, Lopez-Jaramillo P. Trials. 2007 Sep 26;8(1):26 [Epub ahead of print]
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BACKGROUND: Diabetes Mellitus constitutes one of the most important public health problems due to its high prevalence and enormous social and economic consequences. Diabetic foot ulcers are one of the chronic complications of diabetes mellitus and constitute the most important cause of non-traumatic amputation of inferior limbs. It is estimated that 15% of diabetic population will develop an ulcer sometime in their life. Although novel therapies have been proposed, there is no effective treatment for this pathology. Naturally produced nitric oxide participates in the wound healing process by stimulating the synthesis of collagen, triggering the release of chemotactic cytokines, increasing blood vessels permeability, promoting angiogenic activity, stimulating the release of epidermical growth factors, and by interfering with the bacterial mitochondrial respiratory chain. Topically administered nitric oxide has demonstrated to be effective and safe for the treatment of chronic ulcers secondary to cutaneous leishmaniasis. However, due to their unstable nitric oxide release, the topical donors needed to be applied frequently, diminishing the adherence to the treatment. This difficulty has led to the development of a multilayer polymeric transdermal patch produced by electrospinning technique that guarantees a constant nitric oxide release. The main objective of this study is to evaluate the effectiveness and safety of this novel nitric oxide releasing wound dressing for the treatment of diabetic foot ulcers.
Methods and Design. A double-blind, placebo-controlled clinical trial, including 100 diabetic patients was designed. At the time of enrollment, a complete medical evaluation and laboratory tests will be performed, and those patients who meet the inclusion criteria randomly assigned to one of two groups. During 90 days group 1 will receive active patches and group 2 placebo patches. The patients will be seen by the research group at least every two weeks until the healing of the ulcer or the end of the treatment. During each visit the healing process of the ulcer, the patient's health status and the presence of adverse events will be assessed. Should the effectiveness of the patches be demonstrated an alternative treatment would then be available to patients. Trial registration: NCT00428727
Re: Trial of nitric oxide patch in diabetic foot ulcers
Here is more on the role of nitric acid:
ScienceDaily are reporting: Diabetes Makes It Hard For Blood Vessels To Relax
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ScienceDaily (Jan. 31, 2008) — One way diabetes is bad for your blood vessels is by creating too much competition for an amino acid that helps blood vessels relax, researchers say.
That amino acid, L-arginine, is broken down by the enzyme arginase to urea, which helps the body eliminate toxins resulting from the proteins we eat. Diabetics have a lot of arginase activity, which means they use a lot more L-arginine, says Dr. Maritza Romero, postdoctoral fellow at the Medical College of Georgia and lead author of the paper published in the current issue of Circulation Research.
It also means too little L-arginine is available to help nitric oxide synthase make nitric oxide, the powerful vasodilator that helps blood vessels relax, says Dr. Romero, who works in the lab of Dr. R. William Caldwell, chair of the MCG Department of Pharmacology and Toxicology and the study's corresponding author.
Researchers also found the amino acid, L-citrulline, as well as statins, compounds known to lower cholesterol, prevent elevation of arginase activity, restoring normal dilation abilities in animal models of type 1 diabetes. In fact, L-citrulline can be recycled into L-arginine.
Now they want to know specific factors and pathways involved in arginase activation and develop pharmaceutical agents to combat excessive arginase activity in diabetes. They also suggest clinical trials of L-citrulline ...
Trial of nitric oxide patch in diabetic foot ulcers
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