Safety and Efficacy of the Noxsano Wound Care Bandage: A First in Human Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- OhioHealth
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Adverse Events - Healthy Volunteers
研究概览
简要总结
This study is a prospective, interventional, non-randomized study designed to assess the safety and efficacy of the Noxsano Bandage (study device) in healthy subjects and wound care subjects with a diabetic lower extremity ulceration and/or arterial insufficiency lower extremity ulceration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: Subjects must meet all of the following criteria to be eligible for enrollment:
- •Subject is ≥ 18 and < 80 years of age.
- •Subject is white, black or African American
- •Subject has provided written informed consent.
- •Subject is willing to comply with study follow-up requirements.
- •Subject has intact skin on lower extremities.
- •Group 2: Subjects must meet all of the following criteria to be eligible for enrollment:
- •Subject is ≥ 18 and < 80 years of age.
- •Subject has a baseline wound surface area of < 25 cm
- •Subject has provided written informed consent.
- •Subject is willing to comply with study follow-up requirements.
- •Subject with at least one of the following:
- •Diabetic lower extremity ulceration with a hemoglobin A1c (HgbA1c) value ≤ 9.0, drawn within 3 months prior to study participation , and/or
- •Arterial insufficiency lower extremity ulceration with a post-revascularization ankle-brachial index (ABI) value of ≥ 0.40 and ≤ 0.80 on the involved extremity, performed within 3 months prior to study participation1, and/or
- •Diabetic and/or arterial insufficiency lower extremity ulceration deemed in-eligible for revascularization with 3 months prior to study participation
排除标准
- •Group 1: Subjects will be excluded from the trial if any of the following criteria are met:
- •Subject is < 18 or ≥ 80 years of age.
- •Subject has a history of diabetes, arterial insufficiency, or osteomyelitis.
- •Subject has a known hypersensitivity to adhesives.
- •Subject is on any prescription medications, including contraceptives. Due to the short duration of the procedure period (3 days), subjects who initiate prescription medications during study participation will continue in the study.
- •Subject is pregnant, plans to become pregnant during the study period, or is breastfeeding.
- •Subject is non-English speaking or reading.
- •Subject is unable to give informed consent. -
- •Group 2: Subjects will be excluded from the trial if any of the following criteria are met:
- •Subject is < 18 or ≥ 80 years of age.
- •Subject has a baseline wound surface area of ≥ 25 cm
- •Subject has a plantar wound.
- •Subject with diabetes with an HgbA1c value of > 9.0, drawn within 3 months prior to study participation . Subject with arterial insufficiency with an ABI value of < 0.40 or > 0.80, performed within 3 months prior to study participation .
- •Subject with osteomyelitis contiguous with the ulceration treatment site.
- •Subject with peripherally-inserted central catheter (PICC) line antibiotic treatment within the previous 6 months.
- •Subject requiring any type of amputation on the treatment limb within 3 months prior to study participation.
- •Subject with a known hypersensitivity to adhesives.
- •Subject is on active steroid therapy (does not include inhaled steroids).
- •Subject is pregnant, plans to become pregnant during the study period, or is breastfeeding.
- •Subject is non-English speaking or reading.
- •Subject is unable to give informed consent.
- •Subject is currently enrolled in another interventional study.
研究组 & 干预措施
Healthy Volunteers
The initial phase of the study is designed to determine the safety of the study device, the Noxsano Bandage, in healthy volunteers without wounds.
干预措施: Noxsano Bandage (Healthy Volunteers) (Device)
Wound care
The second phase of the study is designed to determine the effectiveness of the study device in wound healing in subjects with active wounds.
干预措施: Noxsano Bandage (Wound Care) (Device)
结局指标
主要结局
Adverse Events - Healthy Volunteers
时间窗: 4 weeks post-bandage removal
Adverse events related to the Noxsano bandage will be assessed using a safety and adverse reactions questionnaire that includes questions for the subject regarding tolerance, side effects, and adverse events.
Wound Surface Area
时间窗: change in baseline wound area at 2 months
Wound surface area will be measured using a horizontal and vertical measurement taken in centimeters (cm) using a standard ruler. These measurements are used to calculate wound area in centimeters squared (cm2).
次要结局
- Adverse Events - Wound Care Subjects(12 months post-treatment)