NCT07219004已完成不适用
A Prospective Multi-ceter Clinical Trail. Evaluating the Efficacy of Tri-layer Amnion/Chorion/Amnion (Artacent-AC) and Standard of Care in the Treatment of Chronic Lower Extremity Diabetic Ulcers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Rate of wound closure by percent of complete epithelialization
研究概览
简要总结
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.
详细描述
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period. During this trial the patient will undergo a screening period where SOC is used to see if the patient will respond and heal > 20% of the surface area in 2 weeks. if the patient can not heal more than 20% in two week the patient then will receive a trial-layered human amnion/chorion/amnion composite graft weekly for 12 week and precent wound area reduction and complete wound healing will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subjects will be eligible to participate in the study if all the following conditions exist:
- •Potential subjects are required to meet all the following criteria for enrollment into the study.
- •Subjects must be at least 18 years of age or older,
- •Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
- •At entry subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the MolecuLight Imaging HCT/P 361 .
- •The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
- •The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- •The target ulcer must be full thickness without exposed bone.
- •The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
- •ABI between 0.7 and ≤ 1.3;
- •TCOM ≥ 40 mmHg;
- •PVR: biphasic.
- •If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
排除标准
- •will be designated as the target ulcer.
- •Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
- •The subject must consent to using the prescribed off-loading method for the duration of the study.
- •The subject must agree to attend the weekly study visits required by the protocol.
- •The subject must be willing and able to participate in the informed consent process.
- •Exclusion Criteria:
- •Subjects will be excluded from participation in the study if any of the following conditions exist:
- •A subject known to have a life expectancy of < 6 months is excluded.
- •The subject is excluded if the target ulcer is not secondary to diabetes.
- •If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
- •If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
- •A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- •A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
- •The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
- •A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
- •If a subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit he/she is excluded.
- •The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the subject received SOC.
- •A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
- •Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
- •A potential subject with end stage renal disease requiring dialysis is excluded.
- •A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days is excluded.
- •A subject who in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
- •A Subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.
结局指标
主要结局
Rate of wound closure by percent of complete epithelialization
时间窗: 12 weeks
complete wound closure measured by 100% epithelialization
次要结局
- Percent area reduction(12 weeks)
研究者
研究点 (10)
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