Evaluation of the effectiveness of sodium phenytoin dressing on wound healing among the patients with Diabetic foot ulcer at Tata Motors Hospital,Jamshedpur
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of complete ulcer healing.
研究概览
简要总结
Diabetic foot ulcer is a common complication of diabetes. The healing of
diabetic foot ulcers depends on multiple factors such as glycemic control,
vascularity, bacterial load, location of the wound, nutritional status of the
patient, etc. The standard wound care of diabetic foot ulcer relies primarily
on pressure relief, debridement and maintenance of a moist wound
environment. Phenytoin’s wound healing promoting effect has been
attributed to many mechanisms including increasing fibroblast proliferation,
inhibiting collagenase activity, promoting collagen deposition, enhancing
granulation tissue formation, decreasing bacterial contamination, reducing
wound exudates formation and up-regulating growth factor receptors.
Biopsies of phenytoin treated wounds show neovascularization,
collagenization and decreased polymorphonuclear and eosinophil cell
infiltration. Topical phenytoin can enhance wound healing in diabetic foot
ulcers but further research is required to establish the role of phenytoin as
healing agent. The present study is a proof-of-concept study being
conducted on a pilot basis to assess the efficacy of topical phenytoin
dressing as compared to conventional wound dressing with normal saline
in the healing process of diabetic ulcers, and to determine its efficacy in
the management of diabetic ulcers
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with diabetic foot ulcer irrespective of gender.
- •Both Inpatients and outpatients with Diabetic foot ulcer.
排除标准
- •Ulcers of other etiology.
- •Other comorbid conditions like renal failure, generalized debility which adversely affect wound healing.
- •Patients allergic to phenytoin .
- •patients who are immunocompromised or under immunosuppression therapy.
结局指标
主要结局
Incidence of complete ulcer healing.
时间窗: 8 weeks
次要结局
- Time to achieve complete wound closure(8 weeks)
- Percentage reduction total ulcer surface area(8 weeks)
研究者
Ponnam Amarnadh
Tata Motors Hospital