%0 Journal Article
%T Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch: PATHON
%A Sandra Y Silva
%A Ligia C Rueda
%A Gustavo A M¨¢rquez
%A Marcos L¨®pez
%A Daniel J Smith
%A Carlos A Calder¨®n
%A Juan C Castillo
%A Jaime Matute
%A Christian F Rueda-Clausen
%A Arturo Orduz
%A Federico A Silva
%A Piyaporn Kampeerapappun
%A Mahesh Bhide
%A Patricio L¨®pez-Jaramillo
%J Trials
%D 2007
%I BioMed Central
%R 10.1186/1745-6215-8-26
%X 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. Over the course of 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.NCT00428727.Diabetes Mellitus (DM) constitutes one of the most important public health problems with a worldwide impact due to its high prevalence and enormous social and economic consequences. It is believed that there are more than 135 million diabetics, and this number is expected to increase to 300 million in the next 25 years (30% in developed and 70% in developing countries) [1,2].This epidemic is related to several factors like ethnicity, the longer life expectancy, and the epidemiological and nutritional transition in developing countries due to the urbanization process that brings about obesity and sedentarism [3,4]. In Colombia, the 2002 basic health indicators showed a 2% prevalence of DM. However, it is believed that these numbers are underestimated [5]. Diabetic Foot Ulcers (DFU) are one of the chronic consequences of DM which constitute the most important cause of non-traumatic amputation of the Inferior Limbs (IL), and are associated with high human, social and economic costs [6-11]. It is estimated that approximately 15% of the diabetic population will develop a DFU some time in their life [12-16].DFU is a consequence of two of the most frequent chronic complications of DM: Peripheral neuropathy and vascu
%U http://www.trialsjournal.com/content/8/1/26