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Chlorhexidine Gluconate Solution at 0.125% vs Placebo for the Healing of Grade IIB Ulcers of Diabetic Foot

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209466
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jose Antonio de Jesus Alvarez Canales, Universidad de Guanajuato

Brief Summary:
There is controversy regarding the utility of antiseptics in wound management for diabetic foot ulcer syndrome. The aim of this study is to assess chlorhexidine gluconate at 0.125% vs. saline solution to reduce the ulcerated area in patients with diabetic ulcer syndrome. A clinical trial model to evaluate modifications in size and area is proposed. Patients to be included will be those with diabetic foot ulcers Graded II accordingly to the University of Texas wound classification system.

Condition or disease Intervention/treatment Phase
Diabetic Foot Drug: Chlorhexidine gluconate at 0.125% Drug: Placebo Comparator with physiological saline sterile solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Standard Management and Chlorhexidine Gluconate Solution at 0.125% Versus Standard Management and Physiological Saline Sterile Solution for Healing Grade IIB Ulcers in Diabetic Foot Syndrome: Clinical Trial
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 30, 2020


Arm Intervention/treatment
Experimental: Standard management and Chlorhexidine gluconate at 0.125%
Application every 24 hours, six weeks Intervention: Procedure: chlorhexidine gluconate
Drug: Chlorhexidine gluconate at 0.125%
Application every 24 hours, six weeks Intervention: Procedure: chlorhexidine gluconate

Placebo Comparator: Standard management and physiological saline sterile solution
Application every 24 hours, six weeks Intervention: Other: physiological saline sterile solution
Drug: Placebo Comparator with physiological saline sterile solution
Standard management and physiological saline sterile solution with application every 24 hours, six weeks Intervention.




Primary Outcome Measures :
  1. Ulcerated area [ Time Frame: Up to 6 weeks ]
    area of diabetic foot ulcer measured with photographic register using a visual control of dimensions and a dedicated software for measurements.



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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:

  • Ambulatory patients of both sex over age of 18 years old with diabetes mellitus that present an ulcer caused by diabetic foot syndrome with an extension from skin to tendon or join capsule and infected, classified as Texas IIB.

Exclusion Criteria:

  • Patients lost to follow up and those that voluntary leave 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): NCT03209466


Contacts
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Contact: Jose A Alvarez, PhD 52 477 2674900 ext 4643 alvarez_ja@me.com

Locations
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Mexico
Universidad de Guanajuato Recruiting
Leon, Guanajuato, Mexico, 37320
Contact: Juan M Muñoz, MD       jmunozb@me.com   
Sponsors and Collaborators
Universidad de Guanajuato
Investigators
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Study Director: Alejandro E Macias, MD Universidad de Guanajuato

Publications of Results:
Other Publications:
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Responsible Party: Jose Antonio de Jesus Alvarez Canales, PhD, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT03209466    
Other Study ID Numbers: CHXDF
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: None IPD will be share; only group data analyzed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jose Antonio de Jesus Alvarez Canales, Universidad de Guanajuato:
Chlorhexidine gluconate
Diabetic foot ulcer syndrome
Wound healing
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Chlorhexidine
Chlorhexidine gluconate
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents