Phase IV Prospective, Multi-Center, Randomized, Single-Blind, Active and Standard Care-Controlled Study of DermaPure™ in Patients With "Hard to Heal" Chronic, Neuropathic Diabetic Foot Ulcers With Crossover Design for Standard Care Arm
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 13
- 主要终点
- Incidence of wound closure
研究概览
简要总结
This study has been designed to help determine how safe and effective DermaPure™ may be in treating hard-to-heal diabetic foot ulcers compared to the current standard of care.
详细描述
DermaPure™ is a decellularized dermal skin substitute using the Tissue Regenix dCELL® patented Technology to remove cells and other components from human and animal tissue while maintaining the native structural and biomechanical properties. The primary objective of the study is to establish the wound healing performance and safety of DermaPure™ over a 12 week period, when administered to "hard to heal" chronic, neuropathic diabetic foot ulcers. This study has been designed to compare the performance of DermaPure™ (in combination with standard care) versus standard care alone.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or Type 2 diabetes with HbA1c ≤12%
- •Adequate perfusion
- •A full thickness chronic, neuropathic diabetic foot plantar ulcer defined by Texas or Wagner classification.
- •Target ulcer decreases in size (surface area) by less than 30% in the 2 week screening period.
排除标准
- •BMI greater than 45kg/m
- •Presence of infection
- •Presence of necrosis, purulence or sinus tracts that cannot be removed by aggressive debridement.
- •A clinical diagnosis of an active/acute Charcot neuroarthropathy. Inactive/chronic Charcot does not exclude the patient.
- •Therapy with any investigational agent or drug within 4 weeks preceding the screening visit.
- •More than 2 weeks treatment with immunosuppressive agents within 3 months of enrollment.
- •Evidence of malnutrition as confirmed by serum pre-albumin level at screening.
- •Evidence of drug or alcohol abuse,
结局指标
主要结局
Incidence of wound closure
时间窗: 12 weeks
The incidence of full wound closure at or before 12 weeks, where full wound closure is defined as "100% re-epithelialization, without drainage, that has been confirmed at two study visits up to 14 days apart".
次要结局
- Rate of wound healing(12 weeks)
- Quality of wound healing(4 weeks)