A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 537
- 试验地点
- 138
- 主要终点
- Complete Healing of the Study Ulcer by Week 16.
研究概览
简要总结
This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression 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 16-week treatment period is complete. Follow-up visits are conducted monthly for three months in order to assess patients for longer term safety.
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
- •>18 years of age
- •ABI > 0.80
- •Three or fewer venous leg ulcers, if multiple must be separated by 2 cm
- •Ultrasound demonstrates venous reflux >0.5 seconds
- •Study wound present for 1-24 months
- •Study wound 2-15 sq cm surface area
- •Clean, granulating wound
- •Patient able and willing to sign informed consent and comply with study procedures.
- •Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test.
排除标准
- •Wound etiology uncertain or not from venous hypertension.
- •Acute or chronic infectious skin disease
- •Allergy or intolerance to Profore(R)
- •Wound infection, cellulitis, osteomyelitis
- •>2 weeks' treatment with immunosuppressive agents in recent past
- •Investigational drug use within 30 days
- •Severe malnutrition, drug and/or alcohol abuse
- •Malignant disease unless in remission for 5 years
- •History of radiation at the study site
- •Other conditions that could impede wound healing
- •Known history of HIV or AIDS
- •Prior participation in any Dermagraft study
- •Treatment with other bioengineered tissue products within 30 days
- •Unable to understand the aims and objectives of the trial
- •Inability to comply with study protocol
- •NYHA Class III or IV CHF
- •Uncontrolled diabetes mellitus
- •Dorsal foot ulcer
研究组 & 干预措施
1
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
干预措施: Dermagraft(R) (Device)
2
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
干预措施: Profore (Device)
结局指标
主要结局
Complete Healing of the Study Ulcer by Week 16.
时间窗: 16 weeks
次要结局
- Time-to-Complete Healing(From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the "time until CH" was censored at 112 days.)