NCT07779239尚未招募不适用
A Prospective, Multicenter, Multi-Product, Comparative Effectiveness, Randomized Controlled Clinical Trial Evaluating a Novel Wound Bed Optimization Technology (NWBOT) and Standard of Care (SOC) Versus Clostridial Collagenase Ointment (CCO) Plus SOC in Diabetic Foot Ulcers, With Matched-Control Comparison to Topical Hydrogel and Comparisons to Synthetic Standard-of-Care and Topical Collagen Comparator Cohorts.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Percent area reduction (PAR)
研究概览
简要总结
This study is designed to evaluate topical wound products for DFUs using a hybrid design that combines prospectively randomized treatment arms with external control cohorts.
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
- •Adults aged ≥18 years with Type 1 or Type 2 diabetes mellitus.
- •Presence of at least one diabetic foot ulcer with limited granulation tissue.
- •Target ulcer located on the foot, predominantly below the malleolus and not on the dorsal toes.
- •Adequate perfusion of the affected limb as confirmed by vascular assessment.
- •If multiple eligible ulcers are present, the largest qualifying ulcer will be designated as the target ulcer.
- •Willing to comply with the prescribed offloading method and required weekly study visits.
- •Willing and able to provide informed consent and comply with study procedures.
排除标准
- •Target ulcer is not diabetic in origin or has exposed tendon or bone.
- •Clinically significant ulcer-related complications that, in the investigator's judgment, would interfere with study participation or wound assessment.
- •Use of immunosuppressive, cytotoxic, biologic, or other medications expected to interfere with wound healing.
- •Recent topical steroid use on the target ulcer.
- •Prior partial amputation, foot deformity, or other foot condition that prevents adequate offloading of the target ulcer.
- •Pregnancy, planned pregnancy during the study period, or another significant medical condition requiring ongoing supportive treatment.
- •Participation in another interventional clinical trial involving an investigational product within the previous 30 days.
- •Any medical, psychological, nutritional, or hypersensitivity condition that, in the investigator's judgment, may interfere with study participation, assessments, or treatment, including malnutrition or known/suspected hypersensitivity to collagenase or Bonvadis/NWBOT ingredients.
研究组 & 干预措施
Bonvadis® (NWBOT)
Experimental
Eligible subjects will be assigned to receive Bonvadis® (NWBOT) plus Standard of Care.
干预措施: Bonvadis® (NWBOT) (Device)
Clostridial Collagenase Ointment
Active Comparator
Eligible subjects will be assigned to receive Clostridial Collagenase Ointment plus Standard of Care.
干预措施: Clostridial Collagenase Ointment (Device)
结局指标
主要结局
Percent area reduction (PAR)
时间窗: 4 weeks after initial treatment
次要结局
未报告次要终点
研究者
研究点 (10)
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