NCT02512159已完成4 期
Effectiveness of Topical Negative Handicraft Device for Versus Traditional Conservative Treatment in Skin Ulcers Management in Lower Limb
Coordinación de Investigación en Salud, Mexico0 个研究点目标入组 144 人开始时间: 2014年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 主要终点
- Presence of granulation tissue in skin ulcers.
研究概览
简要总结
The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.
详细描述
The hypothesis of this trial is that the handicraft topical device of negative pressure is even better for the treatment of skin ulcers located in the lower limbs of patients with diabetes mellitus, venous stasis and arterial insufficiency. We anticipate that in a sample of 144 patients with ulcer, will heal or at least improve with this treatment
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Juárez, Quintana Roo.
- •Patients of both sexes.
- •Patients over 18 years.
- •Patients that have basic laboratory at admission (complete blood count with differential).
- •Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc.
排除标准
- •Hemodynamically unstable patients.
- •Patients with septic shock from any source.
- •Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure.
- •Patients with secondary cutaneous ulcer enteral fistula.
- •Patients with cutaneous ulcer or cancer tumors.
- •Patients with cutaneous ulcer with active bleeding.
- •Patients with cutaneous ulcer necrosis.
- •Patients with cutaneous ulcer leishmania, insect bite.
- •Patients with cutaneous ulcer burns.
- •Patients who do not accept their participation in the study through informed consent.
结局指标
主要结局
Presence of granulation tissue in skin ulcers.
时间窗: 10 days
Presence of granulation tissue in 50% of the wound
次要结局
- Leukocyte less than 11,000 mm3.(10 days)
- Breathing Rate(10 days)
- Temperature(10 days)
- Heart Rate(10 days)
研究者
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