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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02087215
Other study ID # BRDIAFOOTULCER
Secondary ID
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


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
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