Effect of Local Application of Boron on Diabetic Foot Ulcers

Bezmialem Vakif University

Status and phase: Unknown; Phase 1

Conditions: Diabetic Foot Ulcer

Treatments: Drug: Placebo; Drug: boron gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02087215

BRDIAFOOTULCER

Details and patient eligibility

About

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 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

boron gel

Active Comparator group

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).

Treatment:

Drug: boron gel

control gel

Placebo Comparator group

Description:

placebo gel containing polymer of carbopol ultrex (1%)

Treatment:

Drug: Placebo