NCT02936128终止4 期
A Multicenter, Randomized, Single-Blind Study Comparing the Clinical Outcomes of TruSkin® and an Active Comparator for the Treatment of Chronic Venous Leg Ulcers
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 7
- 主要终点
- Proportion of patients that achieve a 50% or greater reduction in wound size by 8 weeks
研究概览
简要总结
The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic venous leg ulcers.
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 (Participant)
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
- •Between 18 years and 80 years of age inclusive, as of the date of screening
- •An Index Ulcer that is chronic (defined as present for > 4 weeks, but not present for more than 52 weeks at the Screening Visit)
- •Index Ulcer is located on the leg, below the knee
- •The Index Ulcer is a Venous Leg Ulcer (VLU) greater than 10 cm2, inclusive, at the Screening Visit
- •The longest length and longest width measurements for the Index Ulcer are no less than 1 cm each at the Screening Visit
- •The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
- •Wound is free of necrotic debris
- •Patient has adequate circulation to the foot as documented by Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)
- •Confirmed diagnosis of venous insufficiency with duplex ultrasonography to demonstrate reflux of ≥ 0.5 seconds in the superficial lower extremity venous system.
排除标准
- •Index Ulcer is of non-venous pathophysiology
- •Gangrene is present on any part of the affected limb
- •Patient is currently receiving dialysis or planning to go on dialysis
- •Patient has a glycated hemoglobin A1c (HbA1c) level of >12%
- •Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening
- •Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
- •Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
- •Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
- •Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
- •Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site
- •Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
- •Patient has active malignancy other than non-melanoma skin cancer
- •Patient's Index Ulcer has decreased by ≥ 20% during 1-week screening period
- •Patient's random blood sugar is > 450 mg/dl at screening
- •Patient is unable to receive compression therapy as a part of standard of care
- •Patient has untreated alcohol or substance abuse at the time of screening
- •Pregnant women and women who are breastfeeding
- •Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
- •Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies
- •Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
- •Patients who have already been randomized in Protocol 352 at any center may not be considered for screening or for re-entry into the trial at any center, even after the End of Study Visit
- •Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol
研究组 & 干预措施
TruSkin®
Experimental
Cryopreserved skin allograft
干预措施: TruSkin (Other)
Wound Cover
Active Comparator
Active Comparator for Venous Leg Ulcers
干预措施: Wound Cover (Other)
结局指标
主要结局
Proportion of patients that achieve a 50% or greater reduction in wound size by 8 weeks
时间窗: 8 weeks
次要结局
- Number of patients with worsening of index wound defined by ≥ 50% increase in wound size(Up to 84 days)
- Number of product applications(Up to 84 days)
- Proportion of patients that achieve a 50% or greater reduction in wound size by 4 weeks(4 weeks)
- Proportion of patients that achieve complete closure of the index wound by 12 weeks(12 weeks)
- Time to initial wound closure(Up to 84 days)
- Number of AEs(Up to 84 days)
研究者
研究点 (7)
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