An Open-Label, Prospective, Multicenter Study to Assess the Safety and Efficacy of HO/03/03 10-40 Micro Gram (Wound Size Dependence) Applied Topically for up to 24 Weeks in Subjects With Various Etiologies of Hard-to-Heal Wounds
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to Heal
研究概览
简要总结
This multicenter, prospective, open-label, outpatient study will assess the safety and efficacy of HO/03/03 10µg applied topically once daily for up to 24 weeks in up to 100 subjects with Hard to Heal documented chronic wounds of various etiologies (pressure ulcers, diabetic ulcers, post operational wounds surgical incisions ulcers of rheumatoid arthritis and trauma wounds) of at least 4 weeks documentation.
详细描述
All subjects with a wound size of up to 56.25 cm2 (inclusive) will be administered 1 vial of 10 ml HO/03/03 10μg per administration. For each increase in wound size of up to 56.25 cm2 an additional vial of HO/03/03 10 μg will be added up to a maximal wound size area of 225 cm2 (will be measured by HealOr central reviewer) utilizing 40µg (4 vials) per administration. 15 min post treatment wounds will be dressed according to standard of care.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years old and above.
- •Chronic wounds that have < 30% change in area from Screening
- •Have single / multiple wounds;
- •Have a Hard-to-Heal wound(s) of various etiologies
排除标准
- •Have a documented medical history of a significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), hepatic or per the physician's discretion.
研究组 & 干预措施
HO/03/03 10-40 micro gram
Topically treatment with HO/03/03 10-40µg once daily for up to 24 weeks. Subjects will receive treatment with HO/03/03 10µg at a dose of 1-4 vials (i.e. 10-40 µg/administration) daily depending on their wound size.
干预措施: HO/03/03 10-40 µg (Drug)
结局指标
主要结局
Time to Heal
时间窗: up to 24 weeks
1. 75% wound closure by or on study week 24 (Time to Event Analysis of incidence and time to 75% wound closure).
次要结局
- Wound closure(up to 24 weeks)