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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| boron gel | Active Comparator | diabetic foot ulcer care with 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). |
|
| control gel | Placebo Comparator | placebo gel containing polymer of carbopol ultrex (1%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| boron gel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| number 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. | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| improvement of inflammatory parameters in diabetic foot ulcers | improvement of inflammatory parameters in diabetic foot ulcers including leukocyte count, c-reactive protein and wound culture | up to 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mustafa hasbahceci, md | Contact | +902124531700 | hasbahceci@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| mustafa hasbahceci, md | bezmialem vakif university faculty of medicine dept of general surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mustafa Hasbahceci | Recruiting | Istanbul | 34093 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| ID | Term |
|---|---|
| D001881 | Borates |
| ID | Term |
|---|---|
| D001888 | Boric Acids |
| D001896 | Boron Compounds |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
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|
| Placebo | Drug |
|
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005534 | Foot Diseases |
| D007477 |
| Ions |
| D004573 | Electrolytes |
| D009930 | Organic Chemicals |