NCT06681428招募中不适用
A Multi-Center, Randomized Controlled Clinical Investigation Evaluating an Amnion/Chorion/Amnion Allograft, Amnion/Chorion Allograft, And/or an Amnion/Amnion Allograft Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 17
- 主要终点
- Percentage of DFUs healed at 12 weeks
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
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
- •Potential subjects are required to meet all of the following criteria for enrollment into the study.
- •At least 18 years old, inclusive.
- •Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus.
- •The index ulcer (ulcer to be evaluated in the study) will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
- •Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
- •Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV
- •Within 3 months of SV1, adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of > 0.6 is acceptable.
- •The target ulcer has been offloaded for at least 14 days, prior to TV
- •Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
- •Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
- •Subjects must have read and signed the IRB approved ICF before screening procedures are performed.
排除标准
- •Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent treatment.
- •Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
- •Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
- •Index ulcer is infected
- •Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, 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), Investigational products, or therapeutic device(s) within 30 days preceding SV1
- •History of radiation at the ulcer site (regardless of time since last radiation treatment)
- •Index ulcer has been previously treated or will need to be treated with any prohibited therapies
- •Subjects with a previous diagnosis of HIV or Hepatitis C
- •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
- •Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision)
- •Subject is pregnant or breast-feeding
- •Presence of diabetes with poor metabolic control as documented with an HbA1c >12.0 within last 90 days
- •Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment
- •Presence of acute Charcot Neuroarthropathy to the affected limb
- •Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit
结局指标
主要结局
Percentage of DFUs healed at 12 weeks
时间窗: 12 Weeks
Percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks
次要结局
- Total time to DFU wound closure(12 Weeks)
- Percentage of Wound Area Reduction over time of study(12 Weeks)
- Change in perceived patient wound pain levels over time.(12 weeks)
研究者
研究点 (17)
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