- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03209466
Chlorhexidine Gluconate Solution at 0.125% vs Placebo for the Healing of Grade IIB Ulcers of Diabetic Foot
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
Study Overview
Status
Conditions
Detailed Description
This study will be done in Hospital General de Leon
Population: People with diabetic foot syndrome grade IIb in Guanajuato Mexico
Universe: People with diabetes mellitus and diabetic foot syndrome in Guanajuato
Sample: Patients with diabetes mellitus over age of 18 years old, that present to the wound´s clinic of Hospital General Leon with diabetic foot ulcers classified as Texas IIB. This clinic provides services to patients in Guanajuato with diabetic foot syndrome, including them in a multidisciplinary management program.
Sample size calculation: A minimal sample of 35 patients for each arm of the study was calculated. Each study arm will be balanced considering the size. Potency was calculated at 0.8 and alpha value at 0-5, to detect a difference of 25% on the ulcer size.
Methodology:
Will be invited to participate in the study consecutive patients with diabetes mellitus presented with diabetic foot ulcers Graded II accordingly to the University of Texas wound classification system, in the area of Clinical wounds of Hospital General Leon between May and December 2017.
After explaining the study information and check it is understandable, the investigators provide the sheet to signed the informed consent.
Subsequently selected patients will be measure the ankle brachial index and determine the absence of vascular compromise.
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 will be made.
Patients will be weighed and measured at the first visit and those who don't have biochemical data will be requested to collect this information in subsequent follow-up visits.
The participants will be then treated with the principles of the standard treatment, under the following criteria:
- Remove the ulcer exudate by spraying one of the two ingredients making mechanical drive for 5 minutes, or until completely negative to the visual evidence of exudate.
- Completely remove hyperkeratosis and devitalized tissue from the periphery of the ulcer with cutting material dissection with sterile dressing and drag, until visually eliminate the exudate.
- The treated area is dried.
- Two photographs at a distance of 20 cm perpendicular to the ulcer will be taken, covering a 1 square centimeter reference for measuring the area affected by diabetic foot ulcer syndrome.
- The solution will be applied in a blinded way to the ulcer and covered with sterile gauze for 24 hours.
- The patient will be instructed to continue treatment every 24 hours as follows:
- Sterile gauze will be removed and continuously irrigate for 5 seconds with the ingredient that was assigned.
- Undiscovered for 24 hours, until the next day irrigation gauze area will be placed. Also need to avoid contact with any surface over the affected area until the next assessment.
- Perform the same strategy for 24 hours, and on day 7 must go to the wound clinic to clinical evaluation.
- Every 7 days until complete 6 views, clinical evaluation is performed, irrigation with the selected ingredient and it will take 2 pictures at a distance of 20 cm perpendicular to the ulcer again, covering a reference of 1 square centimeter to measure the area affected by the diabetic foot ulcer syndrome.
Every week during the following 6 weeks, in the wound clinic consultation, it will be measured and gather information of the following elements:
- Ulcer area in square millimeters.
- Color of the ulcer.
- Type of exudate; turbid, serous.
- Type of tissue involved in the ulcer to its depth. If any patients have increased intensity of the signs and symptoms of diabetic foot syndrome, classified as a major step on the scale of ulcers Classification System of the University of Texas, perform analysis and comprehensive treatment will be redefined according to the suggestions of ulcer classification system of the University of Texas.
Cleaning material for the ulcer:
Ingredient 1: Preparation of spray application of chlorhexidine gluconate 0.125%.
Ingredient 2: Preparation of spray application of physiological saline sterile solution.
Method of application of ingredients as described previously. Method of randomization: will be effected since the fabrication of the ingredient by assigning a code number to each of the bottles that contained. Those bottles will have identical presentations, and will balance for 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Guanajuato
-
Leon, Guanajuato, Mexico, 37320
- Recruiting
- Universidad de Guanajuato
-
Contact:
- Juan M Muñoz, MD
- Email: jmunozb@me.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard management and Chlorhexidine gluconate at 0.125%
Application every 24 hours, six weeks Intervention: Procedure: chlorhexidine gluconate
|
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
|
Standard management and physiological saline sterile solution with application every 24 hours, six weeks Intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alejandro E Macias, MD, Universidad de Guanajuato
Publications and helpful links
General Publications
- Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore JC, Schuberth JM, Wukich DK, Andersen C, Vanore JV; American College of Foot and Ankle Surgeons. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006 Sep-Oct;45(5 Suppl):S1-66. doi: 10.1016/S1067-2516(07)60001-5.
- Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. doi: 10.1016/S0140-6736(05)67698-2.
- Stewart PS, Costerton JW. Antibiotic resistance of bacteria in biofilms. Lancet. 2001 Jul 14;358(9276):135-8. doi: 10.1016/s0140-6736(01)05321-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Ulcer
- Diabetic Foot
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Dermatologic Agents
- Disinfectants
- Chlorhexidine
- Chlorhexidine gluconate
Other Study ID Numbers
- CHXDF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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