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:

  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

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

Study Locations

      • Istanbul, Turkey, 34093
        • Recruiting
        • Mustafa Hasbahceci
        • Contact:

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:
  • borate as sodium penta boric acid pentahydrate 3%
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.

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

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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