NCT00235209已完成4 期
A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Clinical effectiveness of CAM in VLU by comparing the reduction in wound area during a 12-week treatment period.
研究概览
简要总结
This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on 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
- Diagnostic
- 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
- •Be 18 years of age or older.
- •Have evidence of venous insufficiency documented by venous duplex scanning or impedance plethysmography within the past 6 months. The study report must contain the actual terms "venous incompetence" or it must be repeated.
- •Have a venous ulcer of >3 but <25 cm2 in area, by planimetry.
- •Have a venous ulcer that has been open continuously for >1 but <18 months prior to treatment.
- •Have been in the prescribed compression for at least 7 days immediately prior to randomization, but no more than 14 days (consecutive or non-consecutive).
- •If female, the subject must: be postmenopausal without menses for at least 1 year, or have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy, or have a negative serum Human Chorionic Gonadotropin (HCG) and be willing to practice an approved form of birth control for the duration of the trial.
- •Subject agrees to participate in the study, including all study related procedures and evaluations and documents this agreement by signing the IRB-approved informed consent.
排除标准
- •Have the designated study wound below the malleolus or above the popliteal fossa.
- •Have been treated with becaplermin (PDGF-BB) or any other topical recombinant therapy to the study wound within the 30 days prior to randomization.
- •Have had the study wound treated, at any time, with a skin substitute or an autologous growth factor.
- •Have had a surgical procedure to treat venous or arterial disease of the affected limb within the past 90 days.
- •Have evidence of significant arterial insufficiency (i.e. an ankle brachial index of < 0.8). Subjects with an ABI >1.0 must have a toe brachial index (TBI) of > 0.6 or a supine transcutaneous oxygen measurement on the affected leg and distal to the wound of >30mmHg.
- •Have clinical evidence of active infection at the wound site.
- •Have evidence of active vasculitis, cellulitis or collagen vascular disease.
- •Have participated in a clinical trial of an investigational agent within the last 30 days.
- •Have significant acute or chronic diseases (i.e., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or infectious diseases) that are not adequately controlled by medical treatment as determined by the Investigator's judgment.
- •Have diabetes mellitus with a hemoglobin A1c > 10%.
- •Have an active skin disease, such as psoriasis, which could impair the ability to assess the study wound.
- •Have an allergy to the components of the dressings used in this study.
- •Require concomitant use of pentoxifylline or clopidogrel bisulfate during the study.
- •Have undergone enzymatic debridement of the study wound at any time during the 7 days prior to the first application of study treatment.
- •Have any requirement for the use of systemic steroids or immunosuppressive or cytotoxic compounds during the period of the study or received low-dose steroid therapy for more than 5 days within the past year.
- •Expect to undergo hyperbaric oxygen therapy at any time during the study.
结局指标
主要结局
Clinical effectiveness of CAM in VLU by comparing the reduction in wound area during a 12-week treatment period.
次要结局
- Effect of the 2 dressing regimens on rate of wound closure, ease of use, pain and adverse events, impact of the dressing regimen
研究者
研究点 (4)
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