Standard Management and Chlorhexidine Gluconate Solution at 0.125% Versus Standard Management and Physiological Saline Sterile Solution for Healing Grade IIB Ulcers in Diabetic Foot Syndrome: Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Ulcerated area
研究概览
简要总结
There is controversy regarding the utility of antiseptics in wound management for diabetic foot ulcer syndrome. The aim of this study is to assess chlorhexidine gluconate at 0.125% vs. saline solution to reduce the ulcerated area in patients with diabetic ulcer syndrome. A clinical trial model to evaluate modifications in size and area is proposed. Patients to be included will be those with diabetic foot ulcers Graded II accordingly to the University of Texas wound classification system.
详细描述
This study will be done in Hospital General de Leon
Population: People with diabetic foot syndrome grade IIb in Guanajuato Mexico
Universe: People with diabetes mellitus and diabetic foot syndrome in Guanajuato
Sample: Patients with diabetes mellitus over age of 18 years old, that present to the wound´s clinic of Hospital General Leon with diabetic foot ulcers classified as Texas IIB. This clinic provides services to patients in Guanajuato with diabetic foot syndrome, including them in a multidisciplinary management program.
Sample size calculation: A minimal sample of 35 patients for each arm of the study was calculated. Each study arm will be balanced considering the size. Potency was calculated at 0.8 and alpha value at 0-5, to detect a difference of 25% on the ulcer size.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory patients of both sex over age of 18 years old with diabetes mellitus that present an ulcer caused by diabetic foot syndrome with an extension from skin to tendon or join capsule and infected, classified as Texas IIB.
排除标准
- •Patients lost to follow up and those that voluntary leave the study.
研究组 & 干预措施
Standard management and Chlorhexidine gluconate at 0.125%
Application every 24 hours, six weeks Intervention: Procedure: chlorhexidine gluconate
干预措施: Chlorhexidine gluconate at 0.125% (Drug)
Standard management and physiological saline sterile solution
Application every 24 hours, six weeks Intervention: Other: physiological saline sterile solution
干预措施: Placebo Comparator with physiological saline sterile solution (Drug)
结局指标
主要结局
Ulcerated area
时间窗: Up to 6 weeks
area of diabetic foot ulcer measured with photographic register using a visual control of dimensions and a dedicated software for measurements.
次要结局
未报告次要终点
研究者
Jose Antonio de Jesus Alvarez Canales
PhD
Universidad de Guanajuato