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Diabetic Foot Ulcer. Effectiveness of Chlorhexidine Gluconate 0.125 % Compared With Sterile Deionized Water

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02097615
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : August 19, 2016
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Alejandro E. Macias, Universidad de Guanajuato

Brief Summary:

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 .


Condition or disease Intervention/treatment Phase
Soft Tissue Infections Procedure: chlorhexidine gluconate Other: deionized water Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of the Effectiveness of Chlorhexidine Gluconate 0.125 % Compared With Sterile Deionized Water in the Closure of Diabetic Foot Ulcer Syndrome.
Study Start Date : May 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: chlorhexidine gluconate
application every 24 hours, six weeks
Procedure: chlorhexidine gluconate
chlorhexidine gluconate spray of 0.125% . Application in the area of the ulcer every 24 hours for six weeks

Other: deionized water
application every 24 hours, six weeks
Other: deionized water
application every 24 hours six weeks




Primary Outcome Measures :
  1. Unlike the ultimate determinations for the initial surface of the ulcer obtained in square millimeters. [ Time Frame: 15 days ]
    Total ulcer area shall be measured by drawing software AUTOCAD LT 2014 , which defines the edges of the ulcer surface area in each of the two photographs , to take an average of the measure and get a value to be analyzed, that value is checked against the reference area of 1 square centimeter to increase measurement accuracy .



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097615


Locations
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Mexico
Hospital General Leon
Leon, Guanajuato, Mexico, 37320
Sponsors and Collaborators
Universidad de Guanajuato
National Council of Science and Technology, Mexico
Investigators
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Principal Investigator: Hugo A Manriquez Perez, Physician Universidad de Guanajuato
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Responsible Party: Alejandro E. Macias, Physician, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT02097615    
Other Study ID Numbers: GTSSA02101-298
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: December 2014
Keywords provided by Alejandro E. Macias, Universidad de Guanajuato:
soft
tissue
infections
Additional relevant MeSH terms:
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Soft Tissue Infections
Diabetic Foot
Foot Ulcer
Infection
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents