NCT06618612招募中不适用
A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Determine the efficacy of multiple Polyhexamethylene Biguanide Antimicrobial (PCMPs) plus SOC versus SOC alone in achieving complete closure
研究概览
简要总结
This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus Standard of Care Alone in subjects with chronic DFUs.
详细描述
At least 170 subjects with a chronic DFU will be randomized 1.4:1:1 to the SOC group, PuraPly AM + SOC, or PuraPly XT + SOC.
Following screening and randomization, subjects shall be seen weekly for up to 12 weeks. For subjects that heal, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure.
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
- •At least 18 years of age or older.
- •Diagnosis of type 1 or 2 Diabetes mellitus.
- •At enrollment, target ulcer with a minimum surface area of 1.0 cm2
- •The target ulcer must have been present for a minimum of 4 weeks
- •The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- •The target ulcer must be Wagner 1 or 2 grade
- •The affected limb must have adequate perfusion confirmed by vascular assessment.
- •If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
- •Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
- •The potential subject must consent to using the prescribed offloading method for the duration of the study.
- •The potential subject must agree to attend the weekly study visits required by the protocol.
- •The potential subject must be willing and able to participate in the informed consent process.
排除标准
- •The potential subject is known to have a life expectancy of < 6 months.
- •The potential subject's target ulcer is not secondary to diabetes.
- •The target ulcer is infected or there is cellulitis in the surrounding skin.
- •The target ulcer exposes tendon or bone.
- •There is evidence of osteomyelitis
- •There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- •The potential subject is receiving immunosuppressants or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing.
- •The potential subject is taking hydroxyurea.
- •The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- •The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
- •The potential subject has a controlled glycated hemoglobin (HbA1c) within 3 months of the initial screening visit.
- •The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
- •Women who are pregnant or considering becoming pregnant within the next 6 months.
- •The potential subject has end stage renal disease requiring dialysis.
- •Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
- •A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- •The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
- •The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
结局指标
主要结局
Determine the efficacy of multiple Polyhexamethylene Biguanide Antimicrobial (PCMPs) plus SOC versus SOC alone in achieving complete closure
时间窗: 12 weeks
The percentage of target ulcers achieving complete wound closure in 12 weeks
次要结局
- Time to closure for the target ulcer.(12 weeks)
- Percentage wound area reduction from Treatment Visit-1 to Treatment Visit-13(12 weeks)
- The number of adverse events.(12 weeks)
研究者
研究点 (2)
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