NCT03621592已完成不适用
An Exploratory, Single Center, Observer Masked, Active Control, Randomized Trial to Investigate the Effectiveness of Dialkylcarbomoyl Chloride Dressing (Cutimed Sorbact) in Modifying Bacterial Load in Venous Leg Ulcers (VLU)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Bacterial Load
研究概览
简要总结
The goal of the study is to investigate the effectiveness of Cutimed Sorbact (Study Device) in modifying bacterial load in venous leg ulcers (VLU).
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 (Outcomes Assessor)
盲法说明
Due to the nature of the study and products, investigator blinding is unrealistic and subject blinding is unlikely. Research staff will avoid naming the dressing or suggesting the assignment to the subjects. However, an independent monitor with experience in treating wounds will be blinded to the treatment assignment and will confirm healing outcomes based on images.
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
- •Adults, 18 years old and older (i.e. age ≥ 18 years).
- •Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness but without exposure of deeper tissues (muscle bone or tendon).
- •If more than one ulcer is present, the largest ulcer meeting criteria shall be designated the study ulcer.
- •If more than one ulcer on the study ulcer limb, study ulcer shall be at least one centimeter from other ulcers.
- •Venous Doppler ultrasound exam, within one year from randomization, shall demonstrate reflux of over 0.5 seconds in the affected limb.
- •Ankle-Brachial Pressure Index (ABI) exam with value of ≥0.80 in the affected limb
- •VLU has been treated with silver based therapy for at least 2 weeks within the previous 6 months.
- •VLU present for at least one month prior to screening visit
- •VLU at least 2 cm2 in size but not larger than 100 cm
- •After debridement, study ulcer demonstrates a clean wound bed.
- •If subject is a female of childbearing potential, subject must use at least one method of contraception acceptable by PI such as birth control pills, Intrauterine Device (IUD), condoms, or sexual abstinence. At visit 1 urine pregnancy test must be negative.
- •Subject is able to comprehend all study related procedures and adhere to study schedule.
- •Subject is able to provide written informed consent.
排除标准
- •Based on investigator medical judgment, ulcer is caused by any etiology exclusive of venous insufficiency.
- •Study Ulcer surface area (post-debridement) has increased or decreased by more than 30% in the period between screening visit 1 and treatment visit
- •Study Ulcer exhibits clinical signs and symptoms of infection in the period between screening visit 1 and treatment visit 1 requiring oral antibacterial therapy.
- •Subject has known allergy to any of the materials used in the study.
- •Subject is unable to tolerate multi-layer compression therapy.
- •Based on investigator medical judgment, the Study Ulcer is suspicious for cancer (e.g. basal cell carcinoma or squamous cell carcinoma).
- •In the month prior to screening visit 1 subject was treated with systemic immunosuppressive medications for more than 2 weeks (e.g. chemotherapy, corticosteroids), and/or it is anticipated subject will require such medications during study period.
- •In the month prior to screening visit 1 subject was enrolled in any other research protocol for treatment of Study Ulcer.
- •The Subject has been diagnosed with malignant disease not in remission over the 5 years immediately preceding screening visit
- •(Except: cervical carcinoma in situ, cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma that have been treated and have no evidence of recurrence or metastases).
- •Study ulcer area has been treated with radiation therapy at any time.
- •In the opinion of PI the subject has a medical condition such as autoimmune, renal, hepatic or hematologic disease that makes the subject an inappropriate candidate for participation in study.
- •In the month preceding screening visit 1 Study Ulcer has been treated with advanced tissue engineered devices matrix based devices (e.g., Apligraf, Dermagraft, Oasis).
- •Subject is diagnosed with New York Heart Association Class III and IV congestive heart.
- •Failure: Class III: Symptoms with moderate exertion or, Class IV: Symptoms at rest.
- •Subject is diagnosed with diabetes mellitus that is poorly controlled and shall be defined as hemoglobin A1C >10%.
- •Study Ulcer is completely or more than 50% of the Study Ulcer is located on the foot (i.e. below the malleolus).
- •Subject is a female of childbearing potential, and refusing to use at least one method of contraception acceptable by PI such as birth control pills, IUD, condoms, or sexual abstinence.
- •Positive pregnancy test in screening visit 1 in a female of childbearing potential or active pregnancy or breast-feeding.
- •In the opinion of the PI the subject is unable to understand or comply with study related protocol including but not limited to providing informed consent.
结局指标
主要结局
Change in Bacterial Load
时间窗: Baseline, Up to 8 weeks
Mean change in bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples
次要结局
- Wound Healing Rate(Up 6 weeks)
- Percentage of Subjects With Complete Healing(Up to 8 weeks)
- Pain as Measured by VAS Scores(Up to 8 weeks)
- Wound Quality of Life (WQoL) Scores(Up to 8 weeks)
- EQ-5D-5L Quality of Life Scores(Up to 8 weeks)
- Number of Adverse Events(Up to 8 weeks)
研究者
Hadar Lev-Tov
Assistant professor
University of Miami
研究点 (2)
Loading locations...
相似试验
撤回
不适用
Novel Device for Reducing Catheter-Related InfectionsIntensive CareNCT00878683University of Kansas
已完成
不适用
Effect of a Basic Skin Care Product on the Structural Strength of the SkinHealthy SkinNCT03625167Prof. Dr. Jan Kottner17
已完成
不适用
Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley CatheterUrinary Tract InfectionsNCT00203515Tyco Healthcare Group1,000
撤回
不适用
Short Duration 6Fed Sponge For EoE PatientsEosinophilic EsophagitisNCT03354221Mayo Clinic
终止
不适用
Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 DiabetesType 2 DiabetesNCT02130401Scion NeuroStim6