A Study to Demonstrate the Safety and Performance of the Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- The reduction in wound size of the target wound between baseline and end of study
研究概览
简要总结
This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.
详细描述
This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers. The primary objective of the study is to demonstrate the performance and safety of Avelle Negative Pressure Wound Therapy on wound and wound fluid management when used in accordance with the instructions for use.
Participation in the study is anticipated to be two weeks. The Avelle™ NPWT System will be used for two weeks and participants will be seen for study visits during this time. Study participants will need to visit the doctor's office up to five times and, at a minimum, will be required to see the health care provider three times, dependent on the condition of the wound. Each visit is anticipated to last for approximately 45 to 60 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Venous insufficiency as defined by CEAP Classification of C6 or C6R or Diabetic foot ulcer
- •Stalled wound/failed treatment in the opinion of the investigator. Defined as a wound that has not progressed by more than 30% in the previous 4 weeks
- •1 qualifying wound which is amenable to NPWT
- •Reliable and available for follow-up
- •Low to moderate exudate
- •Able to tolerate negative pressure
- •>18 years old at the time of consent
- •Able and willing to provide informed consent
排除标准
- •Known sensitivities or allergies to components of the Avelle™ Negative Pressure Wound Therapy System
- •Necrotic wounds or wounds with eschar present
- •Wound is too small or too large based on wound dressing (> 1cm2 and < 100cm2)
- •Wound depth >2cm
- •Use of DuoDERM® gel /petroleum gel/ creams/oil-based products
- •Active treatment for cancer or completed within the last 3 months
- •Severe malnutrition in the opinion of the investigator
- •Visible bone/tendon or exposed articular capsule
- •Exposed blood vessels
- •Clotting disorder
- •Malignant wounds
- •Systemic infection
- •Untreated osteomyelitis
- •Patients with HbA1c greater than 9 on Day 0 (Test to be performed within last 3 months)
- •Wounds greater than 12 months old
- •Previous failed NPWT within last 6 weeks on the qualifying wound
- •Active Pregnancy
- •Chronic Kidney Disease score of 5
结局指标
主要结局
The reduction in wound size of the target wound between baseline and end of study
时间窗: 14 days
Area reduction will be assessed by measuring the wound area at Day 0, Day 6 (+/- 1 day), and Day 7 (+/- 1 day)
次要结局
- Wound Healing Status(14 days)
- Assessment of Skin(14 Days)
- Rate of Device Related Adverse Events(14 days)