A Multi-center Randomized Controlled Clinical Trial Evaluating Two Application Regimens of Amnioband Dehydrated Human Amniotic Membrane and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 8
- 主要终点
- Time to complete ulcer closure
研究概览
简要总结
Lower extremity ulcers pose significant clinical, humanistic and economic burdens on society. Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs).1-5 Under the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care specialists see patients who have suffered for years or faced amputation of the limb as their only option to alleviate the pain.
Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However, roughly half of patients suffering from venous ulcers will require advanced therapy. Human amniotic membrane replaces the damaged extracellular matrix characteristic of chronic ulcers. In addition, it contains cytokines that may accelerate healing. In clinical practice and recent studies, Dehydrated Human Amniotic Membrane has appeared to be as effective as bioengineered skin products. This RCT is designed to evaluate Amnioband Dehydrated Human Amniotic Membrane in venous leg ulcers.
详细描述
This study is a multi-center, randomized, trial designed to evaluate the safety and effectiveness of Amnioband Dehydrated Human Amniotic Membrane plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers.
The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The choice of compression will be at the discretion of the principle investigator.
The Screening Phase (1-14 days) consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria (described in more detail below), At or up to 14 days before the first Screening Period Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure.
Subjects who have not been treated with compression therapy for the target ulcer must receive a minimum of 14 days of compression prior to enrollment.
At the first Screening Period Visit (S1), the Investigator will select the study (target) ulcer. Each subject will have only one VLU selected as the study (target) ulcer. In the situation where a subject has more than one VLU at the S1 visit, the Investigator will select the largest VLU that meets the eligibility criteria of the protocol as the study (target) ulcer.
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
- 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
- •At least 18 years old.
- •Ankle Brachial Pressure Index (ABI) > 0.75 OR SPP > 30 mmHg OR TCOM > 30 mmHg.*
- •Presence of a venous leg ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone.
- •The largest ulcer will be designated the index ulcer and the only one included in the study. If other ulcerations are present on the same leg they have to be more than 2 cm apart from the index ulcer.
- •Study ulcer (i.e. current episode of ulceration) has been present for greater than one month prior to the initial screening visit, and has failed to respond to documented conservative measures for greater than (1) one month duration and is excluded if it has undergone 12 months of continuous high strength compression therapy over its duration.
- •Study ulcer is a minimum of 2 cm2 and a maximum of 20 cm2 at the randomization visit.
- •The target ulcer has been treated with compression therapy for at least 14 days prior to randomization.
- •Ulcer has a clean, granulating base with minimal adherent slough at the randomization visit.
- •Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- •Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
- •Subject has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.
排除标准
- •Study ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency.
- •Study ulcer exhibits clinical signs and symptoms of infection.
- •Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
- •Study ulcer, in the opinion of the investigator, is suspicious for cancer should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- •Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- •Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding Screening.
- •Study ulcer improving greater than 30% during the screening phase if the subject was not in adequate compression 14 days prior to screening.
- •History of drug or alcohol abuse.
- •History of radiation at the ulcer site.
- •Presence of one or more medical conditions, as determined by medical history, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this ulcer healing study.
- •History of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- •Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days
- •Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
- •Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
- •Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
- •Pregnant or breast feeding.
- •Presence of diabetes with poor metabolic control as documented with a HgA1c > 12.0 within last 90 days
- •Patients with renal dysfunction whose serum creatinine levels are 3.0mg/dl or greater within the last 90 days
- •History of usage of tobacco products within the last 30 days
- •History of Liver disease with active Cirrhosis of the liver
研究组 & 干预措施
Biweekly application of Amnioband
Biweekly application of Amnioband plus standard of care.
干预措施: Standard of Care (Other)
Weekly application of Amnioband
Weekly application of Amnioband plus standard of care.
干预措施: Weekly application of Amnioband (Other)
Weekly application of Amnioband
Weekly application of Amnioband plus standard of care.
干预措施: Standard of Care (Other)
Biweekly application of Amnioband
Biweekly application of Amnioband plus standard of care.
干预措施: Biweekly application of Amnioband (Other)
Standard of Care
Subjects randomized to this group will receive standard of care (multi-layer compression therapy).
干预措施: Standard of Care (Other)
结局指标
主要结局
Time to complete ulcer closure
时间窗: 12 weeks
Ulcer closure is based on wound area measurement and absence of wound exudate.
次要结局
- Proportion of ulcers achieving 40% ulcer closure(4 weeks)
- Percentage of ulcers achieving complete closure(12 weeks)
- Incidence of adverse events(12 weeks)
- Cost effectiveness(12 weeks)
- Reduction in pain between treatment groups(12 weeks)
研究者
Thomas Serena
Principal Investigator
SerenaGroup, Inc.