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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03209466 |
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Date of registration:
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01/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Chlorhexidine Gluconate Solution at 0.125% vs Placebo for the Healing of Grade IIB Ulcers of Diabetic Foot
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Scientific title:
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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 |
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Date of first enrolment:
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May 11, 2017 |
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Target sample size:
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35 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03209466 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Alejandro E Macias, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad de Guanajuato |
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Name:
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Juan M Muñoz, MD |
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Address:
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Telephone:
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Email:
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jmunozb@me.com |
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Affiliation:
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Name:
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Jose A Alvarez, PhD |
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Address:
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Telephone:
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52 477 2674900 |
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Email:
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alvarez_ja@me.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetic Foot
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Intervention(s)
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Drug: Placebo Comparator with physiological saline sterile solution
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Drug: Chlorhexidine gluconate at 0.125%
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Primary Outcome(s)
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Ulcerated area
[Time Frame: Up to 6 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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