A Randomized, Open-Label, Multi-Center Study to Compare the Safety and Efficacy of Apligraf Versus Standard Therapy (i.e., Saline Moistened Dressing Regimen) in the Treatment of Diabetic (Primarily Neuropathic) Foot Ulcers
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 82
- 主要终点
- Time to complete wound healing (full epithelialization with no drainage)
研究概览
简要总结
The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.
详细描述
Ulceration of the diabetic foot is a result of multiple problems including repetitive stress on a neuropathic or insensate area that is often associated with an underlying bony prominence. By healing diabetic foot ulcers quickly the risks of infection, osteomyelitis (infeciton of the bone) and limb loss can be reduced.
This study will evaluate the ability of Apligraf to heal diabetic foot ulcers that have been present for at least 2 weeks and are between 1 - 16 cm2 in area. Patients will be randomized to either (50:50 chance) treatment with Apligraf or a saline moistened dressing regimen (standard therapy). All patients will receive standard cares for the ulcers which includes debridement, orthotics and off-loading throughout the treatment period.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot
- •ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure
- •ulcer present for at least 2 weeks and measuring 1- 16 cm2
- •diminished sensesation on target extremity/foot
- •ulcer is not infected
- •Type 1 or 2 diabetes with adequate glycemic control
- •Adequate vascular supply to the target extremity
排除标准
- •Charcot foot
- •Non-neuropathic ulcers
- •Skin cancer within or adjacent to the target ulcer
- •Osteomyelitis or an infected ulcer
- •Clinically significant medical condition that would impair wound healing
- •Females who are pregnant
- •Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy
结局指标
主要结局
Time to complete wound healing (full epithelialization with no drainage)
时间窗: through 12 weeks
次要结局
- Incidence of complete healing(at 12 weeks)