A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).
研究概览
简要总结
This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.
详细描述
This clinical evaluation with DermACELL AWM will explore its use in the treatment of complex soft tissue defects involving muscle, fascia, tendon, or bone exposure (Wagner Classification 3 and 4).
A total of 50 subjects will be treated with DermACELL AWM in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic for up to 16 weeks.
The specific aim of the study is to assess the ability of the product to sustain an optimal dermal layer. The time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM) and safety data will be collected.
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wagner Grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
- •target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration)
- •target wound that is not amendable to primary closure
- •target wound deemed without any residual infection (as assessed by Investigator) or is being treated upon entry into the clinical trial
- •adequate perfusion to the extremity
- •laboratory assessments which represent a good potential for wound healing (liver and kidney function, nutritionally stable and diabetes control)
排除标准
- •untreated infection of soft tissue or bone
- •untreated autoimmune connective tissue disorders
- •body mass index (BMI) of ≥ 50
- •undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication
- •active liver disease (e.g. hepatitis A-G),
- •have undergone previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment
- •enrolled in any other interventional clinical research trial
- •an increase or decrease of more than 25% in wound area or volume from the Screening to Baseline visit.
结局指标
主要结局
Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).
时间窗: 112 Days
Days required for granular bed formation
次要结局
- Number of applications of study product required to achieve granulation.(16 Weeks)
- Percent wound area reduction and percent complete wound closure at 16 Weeks.(16 Weeks)
- The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation.(16 Weeks)