Clinical Trial of the Effectiveness of Chlorhexidine Gluconate 0.125 % Compared With Sterile Deionized Water in the Closure of Diabetic Foot Ulcer Syndrome.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Unlike the ultimate determinations for the initial surface of the ulcer obtained in square millimeters.
研究概览
简要总结
At present research has generated controversy regarding the utility of antiseptics in wound management for diabetic foot ulcers syndrome. However, these studies have been done in tissues and animal models. This study involves the best presently antiseptic for residual effect and low toxicity in an approach to eliminate microorganisms promoters formation of biofilm, contributing to the treatment for accelerated closure the diabetic foot ulcers syndrome .
So it is necessary to determine if irrigation ulcer diabetic foot syndrome with chlorhexidine 0.125 % aqueous solution determines the decrease of the surface to a greater extent than the standard treatment using irrigation with sterile deionized water .
详细描述
The present study be made performed at the Hospital General Leon.
Population:
People with Diabetes Mellitus state of Guanajuato.
Universe:
People with diabetes mellitus and diabetic foot syndrome Guanajuato state . sample: Will be evaluated in patients with diabetes mellitus presenting loss of continuity of the skin of the lower limbs and coming to the clinic wound´s of the León General Hospital . This clinic provides services to patients in the state of Guanajuato with diabetic foot syndrome, including them within a multidisciplinary management program .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Indistinct gender
- •Patients over 18 years with Diabetes Mellitus and
- •Submit ulcer from diabetic foot syndrome not involving tendon , capsule or bone.
- •With proper state of vascular perfusion.
排除标准
- •Ulcers in patients with interdigital or difficult to measure the affected surface areas.
- •Patients not be located at follow-up or wish to stop participating in the study.
结局指标
主要结局
Unlike the ultimate determinations for the initial surface of the ulcer obtained in square millimeters.
时间窗: 15 days
Total ulcer area shall be measured by drawing software AUTOCAD LT 2014 , which defines the edges of the ulcer surface area in each of the two photographs , to take an average of the measure and get a value to be analyzed, that value is checked against the reference area of 1 square centimeter to increase measurement accuracy .
次要结局
未报告次要终点
研究者
Alejandro E. Macias
Physician
Universidad de Guanajuato