A Multicenter, Randomized, Controlled, Open Label Trial of DermACELL in Subjects With Chronic Wounds of the Lower Extremities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 23
- 主要终点
- Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have healed.
研究概览
简要总结
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
详细描述
This study is designed to demonstrate the effectiveness of DermACELL in the treatment of chronic wounds of the lower extremities. DermACELL will be compared to conventional care in both subjects with diabetic foot ulcers (DFU) and subjects with venous stasis ulcers (VSU). In addition, DermACELL will be compared to an active comparator, GraftJacket, in subjects with diabetic foot ulcers.
DermACELL and GraftJacket are both made from donated human skin (dermis). These products have been processed so that cells are removed and bacteria and viruses are destroyed. This processing provided a supporting structure, an acellular dermal matrix, into which cells can migrate and divide during the wound healing process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female between the ages of 21 and 80 that are able to provide informed consent, are available for weekly clinic visits and are willing to comply with off-loading requirements of treatment;
- •If diabetic, have been on a stable dose of medication to treat diabetes for less than 30 days;
- •Have a DFU that has been present for at least 30 days or have a VSU that has been present for at least 60 days;
排除标准
- •Have a DFU or VSU that is infected;
- •Are pregnant or lactating;
- •Have an allergy or are sensitive to one of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin;
- •Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol;
- •Have had a HbA1c level greater than 12% within the past 90 days;
- •Have liver function tests or kidney function tests that are very elevated;
- •Have a known or suspected disease of the immune system;
- •Have had surgery in the past 30 days to increase blood flow into your leg or foot;
- •Have cancer or a connective tissue disease (i.e. lupus, rheumatoid arthritis);
- •Have undergone wound healing treatment with a living skin equivalent (i.e., Dermagraft®, Apligraf®, TheraSkin®, Oasis®, GraftJacket®, Integra®, Alloderm®) or topical growth factors in the last 4 weeks;
- •Have active Charcot disease, a weakening of the bones in the foot that can occur in people who have significant nerve damage (neuropathy);
研究组 & 干预措施
DermACELL
DermACELL acellular dermal matrix will be used to treat subjects diagnosed with an ulcer of the lower extremity (diabetic foot ulcer or venous stasis ulcer).
干预措施: DermACELL (Other)
Conventional care dressings
Currently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diagnosis of either diabetic foot ulcer or venous stasis ulcer.
干预措施: Conventional Care Dressings (Other)
GraftJacket
GraftJacket acellular dermal matrix will be used in those subjects diagnosed with a diabetic foot ulcer.
干预措施: GraftJacket (Other)
结局指标
主要结局
Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have healed.
时间窗: 12 weeks
The primary outcome is the comparison of the proportion of chronic wounds treated with DermACELL and treated with conventional care that have achieved 100% re-epithelialization without dressing or drainage requirements at 12 weeks. Wound closure is defined as first observation of 100% re-epithelialization without drainage or dressing requirements and complete wound closure is defined as 100% re-epithelialization without dressing or drainage requirements confirmed at two consecutive study visits 2 weeks apart.
次要结局
- Proportion of wounds closed at 12 weeks and weekly thereafter for up to 24 weeks(24 weeks)