Effect of Local Application of Boron on Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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Local treatment of diabetic foot ulcers: Classification of International Working Group of the Diabetic Foot (IWGDF) pre-treatment measurements including diameter and area pre-treatment laboratory values including fasting glucose, hemoglobin, hemoglobin A1c, leucocyte count and c-reactive protein pre-treatment wound culture 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). post-treatment measurements and values

Official Title
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Prospective Randomized Study of Local Application of Boron on Diabetic Foot Ulcers: Effect of Healing Process

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Drug: boron gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: boron gel<br>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). | Drug: boron gel<br>* 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.<br>* Other names: borate as sodium penta boric acid pentahydrate 3%;|
| Placebo Comparator: control gel<br>placebo gel containing polymer of carbopol ultrex (1%) | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, foot ulcer, boron, wound care