Effect of Local Application of Boron on Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcer
Status
Unknown status
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
boron gel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring diabetes mellitus, foot ulcer, boron, wound care
Eligibility Criteria
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
Sites / Locations
- Mustafa HasbahceciRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
boron gel
control gel
Arm Description
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).
placebo gel containing polymer of carbopol ultrex (1%)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02087215
First Posted
January 28, 2014
Last Updated
November 23, 2014
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT02087215
Brief Title
Effect of Local Application of Boron on Diabetic Foot Ulcers
Official Title
Prospective Randomized Study of Local Application of Boron on Diabetic Foot Ulcers: Effect of Healing Process
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
diabetes mellitus, foot ulcer, boron, wound care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
boron gel
Arm Type
Active Comparator
Arm Description
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).
Arm Title
control gel
Arm Type
Placebo Comparator
Arm Description
placebo gel containing polymer of carbopol ultrex (1%)
Intervention Type
Drug
Intervention Name(s)
boron gel
Other Intervention Name(s)
borate as sodium penta boric acid pentahydrate 3%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
number of the participants with complete epithelization of diabetic foot ulcer
Description
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.
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
number of participants in whom local infective complications develop in diabetic foot ulcer patients
Description
development of local infective complications including osteitis, abscess, osteomyelitis and gangrene
Time Frame
up to 4 weeks
Other Pre-specified Outcome Measures:
Title
improvement of inflammatory parameters in diabetic foot ulcers
Description
improvement of inflammatory parameters in diabetic foot ulcers including leukocyte count, c-reactive protein and wound culture
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mustafa hasbahceci, md
Phone
+902124531700
Email
hasbahceci@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mustafa hasbahceci, md
Organizational Affiliation
bezmialem vakif university faculty of medicine dept of general surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mustafa Hasbahceci
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mustafa hasbahceci, md
Phone
+902124531700
Email
hasbahceci@yahoo.com
12. IPD Sharing Statement
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Effect of Local Application of Boron on Diabetic Foot Ulcers
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