A Prospective, Randomized, Controlled, Single-Site Post Marketing Study to Identify & Characterize the Molecular Mechanisms of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Determine changes in gene expression in subjects receiving Apligraf (includes Apligraf & Control NPTH) compared to 1 week post treatment
研究概览
简要总结
The overall study objective is to use microarray technology to identify and characterize the gene expression of multiple relevant genes in biopsies of non-healing venous ulcers.
详细描述
Subjects with a ≥5 cm2, non-infected target ulcer that has not reduced in area by ≥ 40% since the Screening visit will be randomized at Day 0 to either Apligraf or Control. After enrollment of 25 subjects, randomization will be discontinued and all remaining subjects will receive Apligraf.
Once the target ulcer is assessed by the Investigator as healed at a study visit, the subject's participation in the study is completed (eg, assessed as healed at Week 3, subject would not be required to complete any subsequent study visits).
Apligraf Group (Day 0 to Week 4) Prior to all applications, Apligraf will be fenestrated (perforated) in a standardized manner using a #11 blade with 6 fenestrations per 44 cm2.
For those subjects randomized to the Apligraf group, after Apligraf application, the dressing regimen will include a foam dressing (eg. Mepilex) and a 4 layered compression bandage system (eg. Profore) which will be changed weekly by the Investigator.
After the initial Apligraf application at study Day 0, Apligraf may be applied weekly thereafter for an additional 4 weeks at study Weeks 1, 2, 3, and 4, if, upon visual inspection, adherent Apligraf wound coverage is < 100%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 has at least 1 clinically non-infected full-thickness venous leg ulcer (VLU) at least 5 cm2 in size.
- •Subject is at least 18 years of age or older.
- •Subject must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.
- •Subject must be able and willing to follow study procedures and instructions.
排除标准
- •Subjects who require VAC® (Vacuum Assisted Closure™) therapy on or after Day 0 Study visit.
- •Subject has arterial disease as determined by an Ankle Brachial Index (ABI) measurement of <0.
- •Subject with any systemic or congenital condition like uncontrolled diabetes mellitus, positive HIV test, or any disorder(s) that may compromise wound healing.
- •Subjects with carcinomas located at the target ulcer with biopsy confirmed active malignancy. (Subjects with other carcinoma locations would not be excluded from entry into the study.)
- •Subjects who are currently receiving, or have received at any time within 30 days prior to Screening visit, non-inhaled corticosteroids except topical steroids not at the target ulcer (Inhaled steroid therapy is acceptable on study.), immunosuppressive agents, radiation therapy, hemodialysis, peritoneal dialysis or chemotherapy. (Anticipated use of the above agents or therapies would exclude subject from entry into the study.)
- •Clinical vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases.
- •Signs and symptoms of cellulitis or osteomyelitis at the target ulcer.
- •Avascular target ulcer beds. (Ulcers of mixed etiology such as arterial disease with VLU will be excluded.)
- •Target ulcer with exposed bone, tendon or fascia.
- •Known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
- •Subject enrolled in any wound or investigational study (drug, biologic or device) for any disease within 30 days of the Screening visit.
- •Subject previously treated with Apligraf, Dermagraft® or any other cell therapy at the target ulcer site within 30 days of the Screening visit.
- •Subject with a history of alcohol or substance abuse within the previous year, which could interfere with study compliance such as inability to attend scheduled study visits.
- •Subject who is a current smoker or has not ceased smoking 6 months prior to the Screening visit, or in the opinion of the Investigator, has a smoking history that may compromise wound healing.
- •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.
- •Target ulcer has not decreased in size by > 40% from Screening to Day
- •Confirmed gene expression overlap between the subject's cells (buccal swab) and the cells contained in Apligraf.
结局指标
主要结局
Determine changes in gene expression in subjects receiving Apligraf (includes Apligraf & Control NPTH) compared to 1 week post treatment
时间窗: Apligraf group - Day 0 & Week 1; Control NPTH group-Weeks 4 & 5
Not Predicted to Heal (NPTH) defined as \<40% reduction in ulcer surface area from Day 0 to Week 4
次要结局
- Determine changes in gene expression in subjects receiving Apligraf (includes Apligraf & Control NPTH)compared to subjects not receiving Apligraf at time of initial treatment and at 1 week post treatment(Apligraf group-Day 0 & Week 1; Control NPTH group-Weeks 4 & 5)
- Determine differences in gene expression in following groups (see description section)(Apligraf group-Day 0 & Week 1; Control NPTH group-Weeks 4 & 5)