NCT02087215

Effect of Local Application of Boron on Diabetic Foot Ulcers

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	boron 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.
DRUG	Placebo

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-01-01
• Completion: 2015-03-01
• First posted: 2014-03-14
• Last updated: 2014-11-25

Locations

1 site across 1 country: Turkey (Türkiye)