Effect of Local Application of Boron on Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02087215
• Other study ID #: BRDIAFOOTULCER
• Status: Recruiting
• Phase: Phase 1
• First received: January 28, 2014
• Last updated: November 23, 2014
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: November 2014
• Source: Bezmialem Vakif University
• Contact: mustafa hasbahceci, md
• Phone: +902124531700
• Email: hasbahceci[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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.
• Placebo

Locations

Country	Name	City	State
Turkey	Mustafa Hasbahceci	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes