A Randomized, Prospective, Multi-Center Feasibility Study of APT001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- Wound Closure rate
研究概览
简要总结
The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot ulcer wound and the surrounding wound area as it related to wound healing.
The objective of the study is to assess the Nitric Oxide Therapy treatment time (the number of minutes to deliver the treatment) and frequency (number of days per week to treat) to determine the most optimal treatment time and frequency to develop a rationale for safety and efficacy for the final APT001 clinical study.
详细描述
APT001 is a medical device that generates nitric oxide (NO) from ambient room air within a defined plasma stream. This study is a randomized, prospective, multi-center feasibility study that will assess the effect of Nitric Oxide treatment time (minutes) and frequency (days/week) on wound healing in adults with diabetic foot ulcers (DFUs) and to provide information that will be used to develop final safety and effectiveness hypotheses for a pivotal trial of the APT001 device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Device Feasibility
- 盲法
- Single (Investigator)
盲法说明
Investigator will be blinded to photgraphs and punch biopsy results
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Type 1 or Type 2
- •Wound size greater than or equal to 1 cm2 and less than or equal to 16 cm2
- •HbA1c less than or equal to 12 %
- •Single full thickness DFU on the plantar aspect of toes or foot
- •Ankle Brachial Index greater than or equal to 0.7
排除标准
- •Infection of the ulcer
- •Active Charcot's disease
- •wound involves deeper tissues including bone or tendon
- •Negative pressure therapy on affected foot or Hyperbaric Oxygen Therapy
结局指标
主要结局
Wound Closure rate
时间窗: 12 weeks of treatment
cm2 of epithelium coverage per week
次要结局
未报告次要终点