A Double Blind, Randomized, Controlled Study, Performed in Subjects With Post Traumatic-post Surgical, Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of Polyheal-2 vs PolyHeal in Once Daily Regimen
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase)
研究概览
简要总结
This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical control. The study will enroll adult subjects with post traumatic/post surgical, venus insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be followed for 12 weeks.
详细描述
Subjects will undergo screenibg period of up to two weeks. Following to eligibilidy confirmation subjects will be randomized into one of the two treatment groups and treated with study device once daily for 4 weeks.
Continuation of study device for additional period is based on wound healing progression and under investigator's discretion.
Subjects will be followed up weekly following to 4 weeks of active treatment for additional 8 weeks untol week 12.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hard to heal/chronic post traumatic post surgical ,venus insufficiency and diabetic wound refractory to healing at least 4 weeks prior to study treatment (one or more target wound/s will be eligible per each subject to be treated by the same agent)
- •Subjects who are able to read, understand, and sign the informed consent form. In case of compromised mental capacity, approval and signature of a legal guardian is required.
排除标准
- •Presence of a systemic infection or significant local infection with copious purulent drainage, fluids drainage, gangrene, or cellulites, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement.
- •Wounds with exposed bones, tendons or ligaments
- •Wounds with exposed orthopedic implants
- •Wounds with exposed breast prostheses
- •Uncontrolled diabetes with HbA1c >11%
- •Subjects with BMI greater than 35kg/m2
- •Woman who are pregnant or nursing, or of childbearing potential and are not using adequate contraception
- •Participation in another clinical drug/device trial within 30 days prior to the Screening visit or during this study
结局指标
主要结局
Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase)
时间窗: 4 weeks
次要结局
未报告次要终点