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IRCT20190212042686N1 IRCT 2019-04-16 Tabriz University of Medical Sciences The effect of boron based gel on the treatment of diabetic foot ulcers and infections The effect of boron based gel on the treatment of diabetic foot ulcers and infections 2018-12-06 anticipated 400 Complete https://irct.ir/trial/37784 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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 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. 0 (exploratory trials) diabetic foot ulcer and infections. Intervention 1: 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. Intervention 2: Control group: Treatment for topical ulcers in a way other than mentioned. Yes - There is a plan to make this available What will be shared: A portion of the data will be shared. When: 2019 To whom: University researchers and professors Conditions: For further studies Where to obtain: by Email How to obtain: 21/5000 Request via email Comments:
public Majid Mobasseri
Endocrine & Metabolism Department, Fourth Floor, Imam Reza Hospital, Golghast St, Tabriz, East Azarbaijan
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 3334 8939 mobasserim@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Majid Mobasseri
Golgasht st
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 3177 2047 mobasserimajid@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 75 years Both E12 Malnutrition-related diabetes mellitus Treatment - Drugs Placebo 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. Control group: Treatment for topical ulcers in a way other than mentioned Wound area. Timepoint: 25 to 30 days. Method of measurement: Clinical evaluation. The size of the wound. Timepoint: 25 to 30 days. Method of measurement: Clinical evaluation. Depth of wound. Timepoint: 25 to 30 days. Method of measurement: Clinical evaluation. Infection in the wound. Timepoint: 25 to 30 days. Method of measurement: Clinical evaluation. Tabriz University of Medical Sciences Approved 2018-12-03 Ethics committee of Tabriz University of Medical Sciences Tabriz - Azadi St. - Golghast St. - Central Office of Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)