NCT07041177已完成不适用
Evaluation of the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Chronic Open Wounds: A Prospective Case Series
NuScience Medical Biologics, LLC2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年8月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Complete Wound Closure
研究概览
简要总结
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Open Wounds
详细描述
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will begin SOC plus NeoThelium FT weekly applications. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
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
- •Male or Female, 18 years of age or older
- •Subject has a medical diagnosis of "other" Open wound
- •Subject has a chronic open wound present for 4 weeks or greater (documented in medical record)
- •Ulcer area is a minimum of 1 cm2 and a maximum of 25 cm2 at first treatment visit
- •Index wound has a maximum depth of 1cm at the first treatment visit
- •Subject is able and willing to follow the protocol requirements
- •Subject had signed informed consent
- •Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.
- •The chronic open wound is treated with offloading therapy at the Principal Investigator's discretion, if applicable to location, while standing, sitting, and lying down for 7 days prior to the first treatment visit
- •Wound free of clinical infection or clinically visible exposed bone (no purulent discharge, cellulitis, or osteomyelitis) 7 days prior to treatment visit 1
排除标准
- •Subject is unable to comply with protocol treatment
- •Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
- •Presence of systemic infection, sepsis, or osteomyelitis at screening.
- •Multiple wounds at the same site of the referenced wound with < 2 cm separation from the target ulcer.
- •Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing.
- •Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.
- •Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
- •Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
- •Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
- •Subject is pregnant or breastfeeding
- •Subject with history of immunosuppressant treatment (systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for >2 weeks duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study
- •Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment
- •Index ulcer suspicious of neoplasm in the opinion of the principal investigator
- •Open wound with active infection
- •Wound depth with visible exposed bone
- •Index wound suspicious of neoplasm in the opinion of the principal investigator
研究组 & 干预措施
NeoThelium FT + SOC
Experimental
Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading
干预措施: NeoThelium FT (Other)
结局指标
主要结局
Complete Wound Closure
时间窗: 1-14 weeks
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.
次要结局
- Percentage Wound Area Change(1-12 weeks)
- Follow-Up Closure(2 weeks)
- Time to Closure(1-12 weeks)
研究者
研究点 (2)
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