Boron as a naturally occurring element has some metabolic and inflammatory actions. The antibacterial activity against gram negative bacteria is also known. Boron deficiency is shown to be related with impaired wound bone healing in rats. Therefore, special wound care formulas containing boron may have some positive effect on wound healing of the patients with diabetic foot ulcers.
Local treatment of diabetic foot ulcers: 1. Classification of International Working Group of the Diabetic Foot (IWGDF) 2. pre-treatment measurements including diameter and area 3. pre-treatment laboratory values including fasting glucose, hemoglobin, hemoglobin A1c, leucocyte count and c-reactive protein 4. pre-treatment wound culture 5. treatment either by placebo gel containing polymer of carbopol ultrex (1%) or by formulation gel: addition of borate as sodium penta boric acid pentahydrate 3% (w/v) and two different copolymer as pluronic block namely F68 2% (w/v) and f127 2% (w/v). 6. post-treatment measurements and values
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Mustafa Hasbahceci
Istanbul, Turkey (Türkiye)
RECRUITINGnumber of the participants with complete epithelization of diabetic foot ulcer
healing and complete epithelization of diabetic foot ulcer with regard to time in weeks; comparison with progression or regression of grades of the wound based on classification sytems of International Working Group of the Diabetic Foot (IWGDF) and area of the wound measured as square centimeter.
Time frame: up to 4 weeks
number of participants in whom local infective complications develop in diabetic foot ulcer patients
development of local infective complications including osteitis, abscess, osteomyelitis and gangrene
Time frame: up to 4 weeks
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