The effect of boron based gel on the treatment of diabetic foot ulcers and infections
Design
0.2% Chlorhexidine Dggluconate + 3% Pentahydrate Phenytoinate Gel will be used at least 20 and maximum 30 days. Control group: Treatment of topical ulcers in a method other than the procedure. With 95% confidence, the test power was 95% and using G-Power software, the minimum sample size required was 167. With an estimated 20 percent drop in sample size, the number increased to 400 total. The type of study is a type of interventional study and clinical trial.
Settings and conduct
A clinical, controlled, randomized, and blind clinical trial will be conducted. Classification of the wound and infection of the diabetic foot of the patient are based on the University of Texas system.. In the group treated with 0.2% chlorhexidine digluconate + 3% sodium pentahydrate Pentahydrate twice daily with or without systemic antibiotics is used depending on the patient's condition. In the control group, local ulcers are treated in a way other than the method. Total duration of use is 0.2% chlorhexidine digluconate + 3% sodium pentahydrate Pentahydrate at least 20 days but less than 30 days.
Participants/Inclusion and exclusion criteria
Patients who agree to enroll in the study
Patients with diabetic foot ulcer/ or infection
Patients older than 18 years of age and below 75 years
Patients with or without type 1 diabetes mellitus or infection
Intervention groups
0.2% Chlorhexidine digluconate + 3% sodium glycol Phenytoinate Phenytoinate at least 20 and maximum 30 days with systemic antibiotics.
Treatment of topical ulcers in a way other than mentioned
Main outcome variables
The aim of this clinical trial is to evaluate the effectiveness of 0.2% chlorhexidine digluconate + 3% sodium pentahydrate pentahydrate sodium on wound healing and diabetic foot infections.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190212042686N1
Registration date:2019-04-16, 1398/01/27
Registration timing:registered_while_recruiting
Last update:2019-04-16, 1398/01/27
Update count:0
Registration date
2019-04-16, 1398/01/27
Registrant information
Name
majid Mobasseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 8939
Email address
mobasserim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of boron based gel on the treatment of diabetic foot ulcers and infections
Public title
The effect of boron based gel on the treatment of diabetic foot ulcers and infections
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic foot ulcer/ or infection
Patients who agree to enroll in the study.
Patients older than 18 years of age and below 75 years
Patients with or without type 1 diabetes mellitus or infection
Patients who can be treated at outpatient clinics.
Patients who are admitted to treatment.
Exclusion criteria:
Age
From 18 years old to 75 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Given the fact that the sample size is the same in both groups, we use the Excel software and the formula = Rand () to randomize and to increase the precision and balance of the samples in the randomization (for any reason Patient will withdraw from the plan) We use several blocks per group. It will also be provided to the physician to cover the allocation of matte envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
A gel that has an active ingredient in boron with a gel that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the gels themselves do not differ in terms of odor and color, and are completely indistinguishable. (This action was taken by the pharmaceutical company). The important point is that the patient is told that the gel used for the patient may be medication or medication. Clinicians and blind patients will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz - Azadi St. - Golghast St. - Central Office of Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.TBZMED.REC.1397.727
Health conditions studied
1
Description of health condition studied
diabetic foot ulcer and infections
ICD-10 code
E12
ICD-10 code description
Malnutrition-related diabetes mellitus
Primary outcomes
1
Description
Wound area
Timepoint
25 to 30 days
Method of measurement
Clinical evaluation
2
Description
The size of the wound
Timepoint
25 to 30 days
Method of measurement
Clinical evaluation
3
Description
Depth of wound
Timepoint
25 to 30 days
Method of measurement
Clinical evaluation
4
Description
Infection in the wound
Timepoint
25 to 30 days
Method of measurement
Clinical evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 0.2% Chlorhexidine Dggluconate + 3% Pentahydrate Phenytoinate Sodium Gel will be used at least 20 and maximum 30 days with or without systemic antibiotics.
Category
Treatment - Drugs
2
Description
Control group: Treatment for topical ulcers in a way other than mentioned
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital and clinic of Salamat
Full name of responsible person
Majid Mobasseri
Street address
Golestan
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 3901
Email
mobasserimajid@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
A. Ghasem Jouyban
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 9680
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?