Effect of Local Application of Boron on Diabetic Foot Ulcers

Overview

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.

Full Title of Study: “Prospective Randomized Study of Local Application of Boron on Diabetic Foot Ulcers: Effect of Healing Process”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: January 2015

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

Interventions

  • 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.
  • Drug: Placebo

Arms, Groups and Cohorts

  • 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).
  • Placebo Comparator: control gel
    • placebo gel containing polymer of carbopol ultrex (1%)

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bezmialem Vakif University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mustafa Hasbahceci, surgeon – Bezmialem Vakif University
  • Overall Official(s)
    • mustafa hasbahceci, md, Principal Investigator, bezmialem vakif university faculty of medicine dept of general surgery
  • Overall Contact(s)
    • mustafa hasbahceci, md, +902124531700, hasbahceci@yahoo.com

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