NCT02011724Unknown4 期
An Open Label, Multi Center, Post Marketing Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf®
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percent reduction in maximum VLU-related pain at Week 5
研究概览
简要总结
The objective of the study is to demonstrate that treatment with Apligraf reduces venous leg ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful VLU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Subject is a minimum of 18 years of age.
- •Subject has read, understood, and signed an Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
- •Subject is able and willing to follow study procedures and instructions.
- •Subject reports moderate VLU-related pain (defined as ≥4 based on maximum pain level over preceding 24 hours) on numeric rating scale (NRS) at both Week -2 and Day 0).
- •Subject has a partial or full-thickness VLU between 1-60 cm2 and 1-36 months duration, which, in the opinion of the Investigator, has not adequately responded to conventional ulcer therapy.
- •Female subject of childbearing potential has a documented negative urine pregnancy test.
- •Subject (male or female) agrees to use highly effective methods of contraception for the duration of the study.
排除标准
- •Subject has more than 1 VLU.
- •Female subject who is lactating.
- •Subject with significant or severe non VLU-related chronic pain which, in the Investigator's opinion, would impact subject's ability to evaluate their VLU-related pain. Subject with non-VLU-related chronic pain must be on a stable pain medication regimen and must, in the Investigator's opinion, not be anticipated to require a new pain medication for the chronic pain condition during the course of the study.
- •Subject is not willing to discontinue the use of topical analgesics at the VLU (topical anesthetic is permitted for debridement).
- •Subject who has arterial disease, as determined by an ankle-brachial index (ABI), of <0.
- •Subject who has received an investigational drug, device, or biological/bioactive treatment within 30 days prior to study enrollment.
- •Subject who is scheduled to have a vascular intervention on the study extremity during the study.
- •Subject with a biopsy confirmed active malignancy at the VLU. Also, subject with any active malignancy not at the VLU, with the exception of squamous cell carcinoma or basal cell carcinoma.
- •Subject who is currently receiving, anticipates receiving, or has received, at any time within 30 days prior to Screening visit, topical corticosteroids at the VLU.
- •Subject has vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases.
- •Subject has signs and symptoms of wound infection, cellulitis, or osteomyelitis at the VLU.
- •Subject has a VLU with an avascular wound bed.
- •Subject has a VLU with exposed bone, tendon, or fascia.
- •Subject has other wounds (DFU, surgical, etc.) on the same limb as the VLU.
- •Subject has a known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
- •Subject previously treated with Apligraf, or any other cell or tissue-based product at the VLU within 30 days of the Screening visit.
- •Subject who, in the opinion of the Investigator, has a history of alcohol or substance abuse within the previous year that could interfere with study compliance (eg, inability to attend scheduled study visits).
- •Subject, who in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
研究组 & 干预措施
Apligraf
Experimental
干预措施: Apligraf (Device)
结局指标
主要结局
Percent reduction in maximum VLU-related pain at Week 5
时间窗: Day 0 - Week 5
Based on the maximum pain levels during the preceding 24 hours
次要结局
- Reduction on SF-12v2 - Pain Enhanced Health Survey at Week 5(Day 0 - Week 5)
- Reduction in class and/or dose of VLU-related pain medications at Week 5(Day 0 - Week 5)
- Reduction in maximum VLU-related pain at 48 hours following initial Apligraf application(Day 0 - 48 hours after Apligraf application)
- Reduction on Cardiff Wound Impact Schedule (CWIS) at Week 5(Day 0 - Week 5)
研究者
研究点 (1)
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