NCT01181453已完成3 期
A Prospective, Multicenter, Randomized, Single-Blind, Phase III, Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Complete wound closure
研究概览
简要总结
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.
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
- Single
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
- •Patient is 18 years of age or older.
- •Patient has type I or II diabetes.
- •Foot ulcer has been present for a minimum of 2 weeks under the current investigator's care.
- •Foot ulcer is on the plantar surface of the forefoot or heel.
- •Ulcer size is >/=1.0 cm2 at Day 0 (day of randomization).
- •Ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule.
- •Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made up of healthy vascularized tissue.
- •Patient's Ankle-Arm Index by Doppler is >/=0.
- •Patient has adequate circulation to the foot as evidenced by a palpable pulse.
- •Female patients of child bearing potential must not be pregnant and must use accepted means of birth control.
- •Patient and caregiver are willing to participate in the clinical study and can comply with the follow-up regimen.
- •Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before treatment.
- •Patient's study ulcer has been present (open) for at least 6 weeks at the time of the Screening visit.
排除标准
- •There is clinical evidence of gangrene on any part of the affected foot.
- •The study ulcer is over a Charcot deformity.
- •The study ulcer is due to a nondiabetic etiology.
- •The ulcer has tunnels or sinus tracts that cannot be completely debrided.
- •The ulcer is >20 cm2 (longest dimension cannot be greater than 5 cm).
- •The ulcer has increased or decreased in size by 50% or more during the screening period.
- •Presence of medical condition(s) that in the Investigator's opinion makes the patient an inappropriate candidate for this study.
- •Presence of a malignant disease not in remission for 5 years or more.
- •Evidence of severe malnutrition, based on a serum albumin level <2.
- •Presence of patient having known alcohol or drug abuse.
- •A random blood sugar reading >/=450 mg/dL.
- •Presence of urine ketones that are noted to be "Small, Moderate, or Large".
- •Presence of a nonstudy ulcer on the study foot within 7.0 cm of the study ulcer at Day
- •Use of oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, Coumadin or heparin during the study.
- •A history of bleeding disorder.
- •Presence of Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV).
- •Participation in another study involving treatment with an investigational product within the previous 30 days.
- •Elective osseous procedures to the study foot within 30 days prior to the Screening visit.
- •Previous treatment with Dermagraft®.
- •Presence in study ulcer of cellulitis, osteomyelitis or other clinical evidence of infection.
- •Presence of condition(s) that seriously compromise the patient's ability to complete this study.
研究组 & 干预措施
Dermagraft(R)
Experimental
Weekly application of Dermagraft(R) with standard care
干预措施: Dermagraft (Device)
Standard care only
Other
Weekly application of standard care
干预措施: Comparator (Other)
结局指标
主要结局
Complete wound closure
时间窗: 12 weeks
次要结局
- Time to reach complete wound closure(12 weeks)
- Percent of wound closure by study end(12 weeks)
研究者
研究点 (2)
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