NCT00951080已完成不适用
Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 3M
- 入组人数
- 132
- 试验地点
- 34
- 主要终点
- Percent Change in Wound Area
研究概览
简要总结
The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds.
详细描述
This is a prospective, randomized, two-arm, non-inferiority, multi-center study comparing negative pressure therapy wound healing outcomes between the SNaP Wound Care System and traditional NPWT systems.
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
- None
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
- •Subject has Venous Ulcer or Diabetic Ulcer with a surface area < 100 sq. cm and < 10 cm in widest diameter on lower extremity, but larger than 1 sq. cm
- •Subject has wound present for >30 days despite appropriate wound care
- •Subject has adequate blood perfusion (Defined as either transcutaneous oxygen measurements of the dorsum of the foot >30 mmHg or 0.7 < ABI <1.2)
- •Subject has wound in location amendable to creation of airtight seal around wound using NPWT dressings
- •Subject is able to understand and provide written consent
- •Subject able to understand and provide written consent
- •Male or non-pregnant female willing to have urine pregnancy test
排除标准
- •Subject has Active Infection (Redness, Swelling, Pain, Purulent Exudate)
- •Subject has Untreated Osteomyelitis
- •Subject has Allergy to Wound Care Products used in the study
- •Subject has Malignancy, Burn, Collagen Vascular Disease, Sickle Cell, Vasculopathy, or Pyoderma Gangrenosum Origin of Wound
- •Subject has Active Charcot Arthropathy of the Foot
- •Subject has study wound location on toes or plantar surface of foot
- •Subject has uncontrolled hyperglycemia (HbA1C >12%)
- •Subject has end stage renal disease requiring dialysis
- •Subject is undergoing active chemotherapy treatment that inhibits wound healing
- •Subject has had previous treatment with NPWT device, growth factors, hyperbaric oxygen, or bioengineered tissue product within 30 days of enrollment
- •Subject has a >30% wound surface area reduction in size at 1 week after screening visit
- •Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
- •Subject is unwilling or unable to comply with protocol requirements
- •Subject is pregnant
结局指标
主要结局
Percent Change in Wound Area
时间窗: Baseline and 16 weeks
The percent change in wound area as measured from Visitrak tracings (Value at 16 weeks minus value at baseline / value at baseline)
次要结局
未报告次要终点
研究者
研究点 (34)
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