NCT01181440已完成3 期
A Prospective, Multicenter, Randomized, Single-Blind 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
- 281
- 试验地点
- 2
- 主要终点
- Proportion of patients with complete wound closure
研究概览
简要总结
This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh. Patients are evaluated weekly until Week 12, then every four weeks until Week 32.
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 old or older.
- •Patient has a current diagnosis of NIDDM or IDDM.
- •Patient's ulcer is present for a minimum of two weeks under the current Investigator's care
- •The study ulcer has healed <50% in size during the two weeks leading up to randomization
- •The study ulcer is on the plantar surface of the forefoot
- •The ulcer is >/= 1.0 cm2 at Day 0 (the day of randomization).
- •The ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule.
- •The ulcer is free of necrotic debris and clinical infection and is comprised of healthy, vascular tissue and is suitable for skin grafting.
- •The patient's Ankle-Arn Index by Doppler is >0.1
- •There is adequate circulation to the foot to allow for healing.
- •The patient's diabetes is under control as determined by the Investigator.
- •Female patients capable of bearing children must test negative for pregnancy and must use an acceptable 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.
排除标准
- •Patient has clinical evidence of gangrene on any part of the affected foot.
- •The ulcer is over a Charcot deformity.
- •The ulcer has a nondiabetic etiology.
- •The ulcer has tunnels or sinus tracts that cannot be completely debrided.
- •The patient's diabetes is uncontrolled and could interfere with the completion of the study.
- •There is a medical condition(s) that in the Investigator's opinion make the patient an inappropriate candidate for this study.
- •Patient has/had a malignant disease not in remission for 5 years or more.
- •Patient has acute or chronic hepatitis, cirrhosis, has a serum albumin of <2.0 gms/dL, or has alkaline phosphatase or LDH at twice the upper limit of the normal range.
- •Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study.
- •Patient has Acquired Immunodeficiency Syndrome (AIDS) or is infected with Human Immunodeficiency Virus (HIV).
- •Patient has participated in another study utilizing an investigational drug or device within the previous 30 days.
- •The ulcer has cellulitis, osteomyelitis, or other clinical evidence of infection.
- •Patient has any condition(s) which seriously compromises their ability to complete this study.
研究组 & 干预措施
Dermagraft(R) and conventional care
Experimental
干预措施: Dermagraft(R) (Device)
Conventional care only
Other
干预措施: Conventional care (Other)
结局指标
主要结局
Proportion of patients with complete wound closure
时间窗: 12 weeks
次要结局
- Time to reach 25%,50%,75%, and 100% of wound closure(32 weeks)
- Percent of wound healed(12 and 32 weeks)
- Wound characterization(32 weeks)
- Recurrence of the ulcer(32 weeks)
- Proportion of patients with complete wound closure(32 weeks)
研究者
研究点 (2)
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