NCT01060670已完成不适用
A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate The Safety and Effectiveness of Integra® Dermal Regeneration Template for the Treatment of Neuropathic Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 545
- 试验地点
- 63
- 主要终点
- Incidence of Complete Wound Closure
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus, neuropathy, and without significantly compromised arterial circulation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type I or Type II diabetes mellitus
- •Glycosylated hemoglobin, HbA1c, ≤ 12%
- •Negative serum pregnancy test at screening for female participants of child-bearing potential
- •Willing and able to maintain the required off-loading (as applicable for the location for the ulcer) and applicable dressing changes
- •At least one DFU that met the following criteria:
- •Ulcer was diagnosed as a full-thickness neuropathic DFU that was located distal to the malleolus (excluding ulcers between the toes but including those of the heel),
- •Minimum 2-cm margin between the qualifying study ulcer and any other ulcers on the specified foot (post debridement),
- •Area greater than or equal to 1 square centimeter and less than or equal to 12 square centimeters (post debridement at the time of randomization),
- •Wagner grade 1 or 2,
- •Depth less than or equal to 5 millimeters with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts,
- •Duration of the study ulcer was at least 30 days at the time of the screening visit
- •Adequate vascular perfusion of the affected limb
排除标准
- •Suspected or confirmed signs/symptoms of gangrene or wound infection on any part of the limb
- •History of hypersensitivity to bovine collagen and/or chondroitin.
- •Pregnancy
- •Previous treatment under this clinical protocol
- •Participation in another clinical trial involving a device or systematically administered investigational study drug or treatment within 30 days of the randomization visit.
- •Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
- •Any unstable condition or circumstance that could interfere with treatment regimen compliance
- •Excessive lymphedema that could interfere with wound healing
- •Unstable Charcot foot or Charcot with boney prominence
- •Ulcers secondary to a disease other than diabetes
- •Osteomyelitis with necrotic soft bone
- •Chopart amputation
- •History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or chemotherapy within the 12 months prior to randomization
- •Treatment with wound dressings that include growth factors, engineered tissues, or skin substitutes within 30 days of randomization or scheduled to receive such treatment during the study
- •Non-study ulcer requiring treatment that could not be treated during the study with moist wound therapy
- •History of or intercurrent illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process
- •Employees or relatives of any member of the investigational site or sponsor
- •Size of the study ulcer following debridement decreased by more than 30% during the run in period
结局指标
主要结局
Incidence of Complete Wound Closure
时间窗: 16 weeks
100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.
次要结局
- Incidence of Ulcer Recurrence(12 weeks)
- Change in Short Form Health Survey (SF-36) Quality of Life Metrics(Baseline and 16 weeks)
- Rate of Wound Closure(16 weeks)
- Incidence of Complete Wound Closure(16 weeks)
- Time to Complete Wound Closure(16 weeks)
研究者
研究点 (63)
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