NCT07158658招募中不适用
Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Pressure Ulcers: A Prospective Case Series
NuScience Medical Biologics, LLC3 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年12月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 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 Chronic Pressure Ulcers
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 Pressure Injury/Ulcer located on the pelvis or lower extremity
- •Subject has a Pressure Injury/Ulcer Stage 2 or 3 without infection
- •Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit
- •Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion
- •Index ulcer has a depth of > 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg
- •Pressure Injury/Ulcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 7 days prior to the first treatment visit
- •Adequate circulation of ulcer, if located on the lower extremity, demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to the first treatment visit
- •Index ulcer is free of infection prior to the first treatment visit and during screening phase.
- •Index ulcer is free of necrotic debris prior to NeoThelium FT application
- •Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit
- •Subject is able and willing to follow the protocol requirements
- •Subject had signed informed consent
- •If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm
排除标准
- •Subject has a known life expectancy of <1 year
- •Subject is unable to comply with protocol treatment
- •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 in the opinion of the investigator
- •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 to tissue-engineered allograft
- •Concurrent participation in alternative clinical trial that involves investigational drug or product 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 >14 days 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 the first treatment visit
- •Pressure Injury/Ulcer of Stage 4 or active osteomyelitis
- •Wound depth with visible exposed bone
- •HBOT within 14 days prior to the first treatment visit
- •Revascularization surgery on the index ulcer leg within 30 days of screening phase
- •Index ulcer suspicious of neoplasm in the opinion of the 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 (HCT/P 361) (Other)
结局指标
主要结局
Complete Wound Closure
时间窗: 1-16 weeks
Complete wound closure (100% epithelialization without drainage)
次要结局
- Percent Area Reduction(1-16 weeks)
- Percent Area Reduction(1-16 weeks)
- Wound Closure(2 weeks)
- Number of Grafts(1-12 weeks)
研究者
研究点 (3)
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