NCT07209475招募中4 期
A Randomized Controlled Multicenter Trial, Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
Royal Biologics8 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2025年8月14日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 248
- 试验地点
- 8
- 主要终点
- Complete Ulcer Closure
研究概览
简要总结
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.
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 the following criteria for enrollment into the study and subsequent randomization.
- •The potential subject is 18 years of age or older. At least 50% of the enrolled population must be > 65 years of age.
- •The potential subject has a history of Type I or Type II Diabetes Mellitus requiring treatment by a physician with either oral medications and/or insulin replacement therapy.
- •Potential subjects have an ulcer characterized by the following:
- •Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided it is at or below the aspect of the medial malleolus. [NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study. Index ulcer must be more than 5 cm distant apart.]
- •A diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.
- •Objectively, less than 20% healing in the two-week screening period prior to randomization.
- •Study ulcer is a minimum of 1.0cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.
- •Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1
- •The subject is able and willing to follow the protocol requirements.
- •Subject has signed informed consent. Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of >6 within 3 months of the first Screening Visit.
- •10. Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control methods, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.
- •11. The index ulcer has been offloaded with protocol defined offloading device throughout the study run-in period for at least 14 days prior to randomization (Run-in period defined as Screening through TV1/Randomization).
- •12. The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.
排除标准
- •The Subject has a known life expectancy of < 1 year.
- •Index ulcer has been present for >1 year.
- •Patient does not have adequate 2-week historical data demonstrating < 20% area reduction.
- •Subject is unable to comply with offloading device.
- •Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
- •Subject has ulcers that are completely necrotic or fibrotic tissue
- •Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- •Subject currently being treated for an active malignant disease
- •or subjects with history of malignancy within the ulcer.
- •The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.
- •Known contraindications to amniotic tissue membranes or known allergies to any of the Amnio-Maxx components.
- •Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- •Index ulcer has reduced in area by 20% or more after 2 weeks of standard of care from the first screening visit (S1) to the TV1/randomization visit.
- •Subject is pregnant or breastfeeding.
- •Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids
- •>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 30 days prior to randomization visit or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- •Index 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 preceding the first treatment visit.
研究组 & 干预措施
Standard of Care
Experimental
Cleansing, debridement, wound documentation, off-loading
干预措施: Standard of Care (Investigator Choice) (Other)
Amnio-Maxx® Dual Layer Amnion Patch
Experimental
Application of Amnio-Maxx® Dual Layer Amnion Patch
干预措施: Amnio-Maxx® Dual Layer Amnion Patch (Biological)
Amnio-Maxx® Dual Layer Amnion Patch
Experimental
Application of Amnio-Maxx® Dual Layer Amnion Patch
干预措施: Standard of Care (Investigator Choice) (Other)
结局指标
主要结局
Complete Ulcer Closure
时间窗: 12 weeks
Expected percentage area reduction (PAR)
时间窗: 12-weeks
次要结局
- Average percentage change from baseline in pain level related to the ulcer estimated from observed data using Numeric Pain Rating Scale (NPRS) and a Bayesian mixed effect model.(12 weeks)
- Adverse events (AE)(12 weeks)
研究者
研究点 (8)
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