Prospective Randomized Study of Local Application of Boron on Diabetic Foot Ulcers: Effect of Healing Process
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- number of the participants with complete epithelization of diabetic foot ulcer
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 1 and 2
排除标准
- •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
研究组 & 干预措施
control gel
placebo gel containing polymer of carbopol ultrex (1%)
干预措施: Placebo (Drug)
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).
干预措施: boron gel (Drug)
结局指标
主要结局
number of the participants with complete epithelization of diabetic foot ulcer
时间窗: 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.
次要结局
- number of participants in whom local infective complications develop in diabetic foot ulcer patients(up to 4 weeks)
研究者
Mustafa Hasbahceci
surgeon
Bezmialem Vakif University