NCT07039396招募中不适用
Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Diabetic Foot Ulcers: A Prospective Case Series
NuScience Medical Biologics, LLC4 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26日最近更新:
适应症
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
- 4
- 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 Diabetic Foot 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 Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy with a diabetic foot ulcer
- •Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.
- •Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at 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.
- •Diabetic foot ulcer is being treated with TCC offloading therapy OR Fixed Ankle Walker if approved by Medical Monitor for 7 days prior to treatment visit 1
- •Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement.
- •Record of serum hemoglobin A1c within 90 days prior to the first treatment visit
排除标准
- •Subject is unable to comply with protocol treatment
- •Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.
- •Wagner 3, 4, or 5 involving tendon, bone, or joint.
- •Presence of systemic infection, sepsis, or osteomyelitis at screening.
- •Multiple DFUs on the same foot 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
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: 1-12 weeks
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure by manual measurement utilizing a ruler.
次要结局
- Percentage Wound Area Change(1-12 weeks)
- Follow-Up Closure(2 weeks)
- Time to Closure(1-12 weeks)
- Hemoglobin A1c(1 week)
研究者
研究点 (4)
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