Diabetic Foot Ulcer
Conditions
Keywords
diabetes mellitus, foot ulcer, boron, wound care
Brief summary
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.
Detailed description
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
Interventions
DRUGboron gel
application of a 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) to diabetic foot ulcers.
DRUGPlacebo
Sponsors
Bezmialem Vakif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 1 and 2
Exclusion criteria
* previous vascular surgery on the side that the ulcer is present * uncontrolled diabetes mellitus * presence of osteitis, abscess, osteomyelitis, gangrene on the side that the ulcer is present * diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of the participants with complete epithelization of diabetic foot ulcer | up to 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of participants in whom local infective complications develop in diabetic foot ulcer patients | up to 4 weeks | development of local infective complications including osteitis, abscess, osteomyelitis and gangrene |
Other
| Measure | Time frame | Description |
|---|---|---|
| improvement of inflammatory parameters in diabetic foot ulcers | up to 4 weeks | improvement of inflammatory parameters in diabetic foot ulcers including leukocyte count, c-reactive protein and wound culture |
Countries
Turkey (Türkiye)
Contacts
Primary Contactmustafa hasbahceci, md
Outcome results
None listed