Diabetic Foot Ulcer. Effectiveness of Chlorhexidine Gluconate 0.125 % Compared With Sterile Deionized Water
Clinical Trial of the Effectiveness of Chlorhexidine Gluconate 0.125 % Compared With Sterile Deionized Water in the Closure of Diabetic Foot Ulcer Syndrome.
1 other identifier
interventional
24
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
March 27, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 19, 2016
December 1, 2014
5 months
March 24, 2014
August 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Unlike the ultimate determinations for the initial surface of the ulcer obtained in square millimeters.
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 .
15 days
Study Arms (2)
chlorhexidine gluconate
EXPERIMENTALapplication every 24 hours, six weeks
Other: deionized water
OTHERapplication every 24 hours, six weeks
Interventions
chlorhexidine gluconate spray of 0.125% . Application in the area of the ulcer every 24 hours for six weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General Leon
León, Guanajuato, 37320, Mexico
MeSH Terms
Conditions
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Hugo A Manriquez Perez, Physician
Universidad de Guanajuato
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
March 24, 2014
First Posted
March 27, 2014
Study Start
May 1, 2014
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
August 19, 2016
Record last verified: 2014-12