NCT00660049已完成不适用
Feasibility Study of a Novel Device for Chronic Wounds
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Ease of Use for Patients
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and usability of a new portable and compact wound dressing device for the treatment of small chronic skin wounds.
详细描述
This is an open label study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Venous stasis ulcer or other chronic wound on the lower extremity that is >1.5cm and <10cm at widest point
- •The wound must have at least 2 cm of intact epithelium surrounding it.
- •A wound such as a pressure ulcer or chronic ulcer on a location other than the lower extremity may also be included in the study if it meets the size requirements and a reliable seal can be achieved.
- •Ulcer must not have healed for >14 days under standard treatment.
- •Chronic wound with prior graft placement will be allowed in the study.
- •Patient is >18 years old.
- •Willing and able to sign informed consent.
排除标准
- •Active wound infection.
- •3+ or greater pitting edema of lower extremity
- •History of malignancy at wound site. However, wounds that are closing by secondary intent after surgical clearance of prior tumor will be allowed in the study.
- •Thick eschar at wound base after debridement.
- •Wound location is not amenable to forming an airtight seal and placement of device.
- •Ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosis lipoidica diabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome.
- •Current smoker (must have quit for >3 weeks)
- •Wound with exposed bone, blood vessels, tendon
- •Significant immunosuppression (as determined by the investigator and sponsor) such as high dose prednisone
- •Fasting blood sugar >200 by study personnel administered bedside fingerstick blood glucose
- •Ankle brachial index less than lower limit of normal (<0.60) as performed and determined by licensed physician (necessary only for patients with lower extremity wounds).
- •Pregnancy
- •Incapable of giving informed consent
- •Inability to comply with study procedures including lack of telephone access for week 8 telephone survey
研究组 & 干预措施
SNaP application
Experimental
This is an "open label" pilot study of SNaP Advanced Wound Care System
干预措施: SNaP Advanced Wound Care System (Device)
SNaP application
Experimental
This is an "open label" pilot study of SNaP Advanced Wound Care System
干预措施: SNaP (Other)
结局指标
主要结局
Ease of Use for Patients
时间窗: Baseline up to 31 days
Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented.
次要结局
未报告次要终点
研究者
Anne Chang
Professor
Stanford University
研究点 (2)
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