NCT01417208撤回不适用
Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- KCI USA, Inc
- 试验地点
- 1
- 主要终点
- Wound Closure
研究概览
简要总结
The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed aetiology leg wounds.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area <100 cm2 and <10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease).
- •Wound present for >30 days.
- •Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings.
- •Patient is able to comply with study protocol requirements.
- •Patient is able to understand and provide written consent.
排除标准
- •Patient has evidence of wound infection in the opinion of the physician.
- •Patient has a thick eschar that persists after wound debridement.
- •Patient has an HbA1C >12%.
- •Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis.
- •Patient has untreated osteomyelitis.
- •Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study.
- •Patient is allergic to the wound care device or occlusive dressing.
- •Patient has exposed blood vessels.
- •Patient is pregnant or pregnancy is suspected.
- •Patient is actively participating in other clinical trials that may interfere with their participation in this study.
结局指标
主要结局
Wound Closure
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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