A Randomized Controlled Trial Comparing Chlorhexidine Soap Versus Povidone Iodine Wash in the Wound Management of Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Mean reduction in Bates Jensen wound assessment tool (BWAT) score
研究概览
简要总结
Diabetic foot ulcers are a common complication of diabetes and a major cause of hospital admissions and amputations. Effective wound cleansing is critical in their management. Two commonly used antiseptics are chlorhexidine and povidone iodine, but there is limited comparative evidence on their effectiveness in wound healing in diabetic foot ulcers.
This single-centre, randomised controlled trial will compare chlorhexidine-containing soap versus povidone iodine wash for wound cleansing in patients with diabetic foot ulcers. Eligible adult patients with Wagner grade 1–4 ulcers will be randomised into two groups. Wound status will be assessed at baseline and after 3 weeks using the Bates-Jensen Wound Assessment Tool (BWAT) by an independent, blinded observer.
The primary outcome is the mean reduction in BWAT score. Secondary outcomes include time to complete healing and incidence of adverse effects.
A total of 66 patients (33 per group) will be included. Standard diabetic foot care, including debridement, offloading, antibiotics if required, and glycaemic control, will be provided to all participants.
This study aims to provide evidence on which antiseptic wash—chlorhexidine or povidone iodine—is more effective for wound healing in diabetic foot ulcers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Presence of Meggitt Wagner grade 1 to 4 diabetic foot ulcer.
排除标准
- •Use of other topical antiseptics or treatments outside protocol Known allergy to chlorhexidine or povidone iodine.
结局指标
主要结局
Mean reduction in Bates Jensen wound assessment tool (BWAT) score
时间窗: Before intervention and after 3 weeks of intervention
次要结局
- Time to complete healing(1 month)
- Incidence of adverse effects(1 month)
研究者
Dr Dennis P Jose
Lakeshore Hospital, Cochin