NCT02087215

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

January 28, 2014

Last Update Submit

November 23, 2014

Conditions

Diabetic Foot Ulcer

Keywords

diabetes mellitusfoot ulcerboronwound care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • number of participants in whom local infective complications develop in diabetic foot ulcer patients

    up to 4 weeks

Other Outcomes (1)

  • improvement of inflammatory parameters in diabetic foot ulcers

    up to 4 weeks

Study Arms (2)

boron gel

ACTIVE COMPARATOR

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).

Drug: boron gel

control gel

PLACEBO COMPARATOR

placebo gel containing polymer of carbopol ultrex (1%)

Drug: Placebo

Interventions

boron gelDRUG

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.

Also known as: borate as sodium penta boric acid pentahydrate 3%
boron gel
PlaceboDRUG
control gel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 1 and 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Hasbahceci

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetic FootDiabetes MellitusFoot Ulcer

Interventions

Borates

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Boric AcidsBoron CompoundsInorganic ChemicalsAnionsIonsElectrolytesOrganic Chemicals

Study Officials

  • mustafa hasbahceci, md

    bezmialem vakif university faculty of medicine dept of general surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mustafa hasbahceci, md

CONTACT

+902124531700hasbahceci@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
surgeon

Study Record Dates

First Submitted

January 28, 2014

First Posted

March 14, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

TU(1)