Effect of Local Application of Boron on Diabetic Foot Ulcers

Phase 1

• Conditions: Diabetic Foot Ulcer
• Interventions: Drug: Placebo; Drug: boron gel

• Registration Number: NCT02087215
• Lead Sponsor: Bezmialem Vakif University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-23
• Last Update Posted: 2014-11-25
• Primary Completion: 2015-01
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 1 and 2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control gel	Placebo	placebo gel containing polymer of carbopol ultrex (1%)
boron gel	boron gel	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mustafa Hasbahceci; 🇹🇷 Istanbul, Turkey