Effect of Local Application of Boron on Diabetic Foot Ulcers

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02087215
Study type	Interventional
Source	Bezmialem Vakif University
Contact	mustafa hasbahceci, md
Phone	+902124531700
Email	hasbahceci@yahoo.com
Status	Recruiting
Phase	Phase 1
Start date	January 2014
Completion date	March 2015

View Details

See also
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