- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02087215
Effect of Local Application of Boron on Diabetic Foot Ulcers
November 23, 2014 updated by: Mustafa Hasbahceci, Bezmialem Vakif University
Prospective Randomized Study of Local Application of Boron on Diabetic Foot Ulcers: Effect of Healing Process
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Local treatment of diabetic foot ulcers:
- Classification of International Working Group of the Diabetic Foot (IWGDF)
- pre-treatment measurements including diameter and area
- pre-treatment laboratory values including fasting glucose, hemoglobin, hemoglobin A1c, leucocyte count and c-reactive protein
- pre-treatment wound culture
- 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).
- post-treatment measurements and values
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: mustafa hasbahceci, md
- Phone Number: +902124531700
- Email: hasbahceci@yahoo.com
Study Locations
-
-
-
Istanbul, Turkey, 34093
- Recruiting
- Mustafa Hasbahceci
-
Contact:
- mustafa hasbahceci, md
- Phone Number: +902124531700
- Email: hasbahceci@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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).
|
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.
Other Names:
|
Placebo Comparator: control gel
placebo gel containing polymer of carbopol ultrex (1%)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of the participants with complete epithelization of diabetic foot ulcer
Time Frame: 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.
|
up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of participants in whom local infective complications develop in diabetic foot ulcer patients
Time Frame: up to 4 weeks
|
development of local infective complications including osteitis, abscess, osteomyelitis and gangrene
|
up to 4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improvement of inflammatory parameters in diabetic foot ulcers
Time Frame: up to 4 weeks
|
improvement of inflammatory parameters in diabetic foot ulcers including leukocyte count, c-reactive protein and wound culture
|
up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: mustafa hasbahceci, md, bezmialem vakif university faculty of medicine dept of general surgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Anticipated)
January 1, 2015
Study Completion (Anticipated)
March 1, 2015
Study Registration Dates
First Submitted
January 28, 2014
First Submitted That Met QC Criteria
March 13, 2014
First Posted (Estimate)
March 14, 2014
Study Record Updates
Last Update Posted (Estimate)
November 25, 2014
Last Update Submitted That Met QC Criteria
November 23, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Diseases
- Diabetic Foot
- Foot Ulcer
- Ulcer
- Physiological Effects of Drugs
- Trace Elements
- Micronutrients
- Boron
Other Study ID Numbers
- BRDIAFOOTULCER
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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