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At present research has generated controversy regarding the utility of antiseptics in wound management for diabetic foot ulcers syndrome. However, these studies have been done in tissues and animal models. This study involves the best presently antiseptic for residual effect and low toxicity in an approach to eliminate microorganisms promoters formation of biofilm, contributing to the treatment for accelerated closure the diabetic foot ulcers syndrome .
So it is necessary to determine if irrigation ulcer diabetic foot syndrome with chlorhexidine 0.125 % aqueous solution determines the decrease of the surface to a greater extent than the standard treatment using irrigation with sterile deionized water .
Full description
The present study be made performed at the Hospital General Leon.
Population:
People with Diabetes Mellitus state of Guanajuato.
Universe:
People with diabetes mellitus and diabetic foot syndrome Guanajuato state . sample: Will be evaluated in patients with diabetes mellitus presenting loss of continuity of the skin of the lower limbs and coming to the clinic wound´s of the León General Hospital . This clinic provides services to patients in the state of Guanajuato with diabetic foot syndrome, including them within a multidisciplinary management program .
Calculation of Sample :
72 patients; more eight for lost estimates, 40 patients for each group are required to have a 80 % chance of detecting , with a significance level of 5%, an increase in the primary outcome measure of 5% in the control group and 6 % in group experimental .
Alpha: 5 % Power : 80 %
Inclusion Criteria:
Indistinct gender Patients over 18 years with Diabetes Mellitus and submit ulcer from diabetic foot syndrome not involving tendon , capsule or bone.
With proper state of vascular perfusion.
Exclusion Criteria :
Ulcers in patients with interdigital or difficult to measure the affected surface areas.
Patients not be located at follow-up or wish to stop participating in the study.
Methodology:
Will be invited to participate in the study patients with diabetes mellitus consecutive presented with ulcers plantar to IA or IB grade classification system ulcers , University of Texas, in the area of Clinical wound´s of the Hospital General Leon between Abril and November 2014.
After explaining the study information and check which is understandable , they provide the sheet to be signed informed consent.
Subsequently selected patients will be given a vascular ultrasound to measure the ankle brachial index and determine the absence of vascular compromise.
They carry out their medical history with emphasis on analyzing clinical data , including the characteristics of the ulcer (type of exudate , measured surface area affected , type of tissue involved in the ulcer to its depth ) and biochemical parameters .
Be weighed and measured at the first visit and not having biochemical data are requested to collect this information in subsequent follow-up visit .
They were then treated with the principles of the standard treatment, under the following criteria :
Material cleaning the ulcer :
Ingredient 1: Preparation of spray application of chlorhexidine gluconate 0.125% .
Ingredient 2: Preparation of spray application of sterile deionized water .
Method of application of ingredients as described previously .
Method of randomization : is effected by assigning random numbers balanced computer, the code will be assigned to each of the ingredients which have identical presentations , they will balance to the sample size . The code will not be known by the patient, observer and analyst. Only be known by one of the advisors.
Statistical methods :
The description of the data, in the case of non-numerical variables will be performed by reporting proportions and confidence interval of 95 % (95 %) in the case of numerical variables, the description will be made based on averages and standard deviation or medians and Q1- Q3 range , depending on the result of the Kolmogorov-Smirnov test to evaluate the Gaussian distribution of the data.
Comparison of numerical variables were not performed by Chi square test . Comparison of the rates of reduction in the size of ulcers of diabetic foot syndrome for both treatments will be based on the t test for independent samples or by Kruskal- Wallis test , depending on data distribution .
In all cases be considered as the significance level alpha value <0.05 .
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24 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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