NCT01320605Unknown2 期
TRIAL OF COMPASSIONATE USE OF HP802-247 TO TREAT VENOUS LEG ULCERS IN SUBJECTS WHO HAVE FAILED MULTIPLE OTHER HEALING TECHNOLOGIES
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Incidence of complete wound closure during the treatment period
研究概览
简要总结
Compound HP802-247 comprises two topical sprays, administered sequentially right after another; these deliver a suspension of fibroblasts and keratinocytes to the wound surface. HP802-247 is the subject of a larger Phase 2 multi-center trial for treating venous leg ulcers. The present study will enroll up to five patients who are suffering venous leg ulcers, have failed a prolonged course of standard wound therapy and one or more advanced technologies, but who would not qualify for the Phase 2 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic (duration greater than six months) open wound that has been diagnosed as a venous leg ulcer on the basis of consultation with a vascular surgeon and/or venous ultrasound evaluation
- •Patient has been under continuous care at the Overlook Hospital Wound Healing Program for at least four months for treatment of the study lesion(s)
- •Total study wound surface area greater than or equal to 12 cm2, but less than 48 cm2
- •Wounds must have failed to heal despite the patient's compliance with elevation, compression and regular debridement, as well as at least one advanced wound therapy (for example, bioengineered dressing such as Oasis® or MatriStem®, low-frequency ultrasound, or cultured skin substitute (Apligraf®, Dermagraft®)
- •Patient has no reasonable likelihood of healing with additional attempts to treat with FDA-approved products and treatments
排除标准
- •Patients eligible to participate in a Healthpoint sponsored clinical study of HP802-247 trial (IND 13,900)
- •Patients who have been previously treated with HP802-247
- •Women of child-bearing potential
- •Patients who are allergic to any of the components of HP802-247
结局指标
主要结局
Incidence of complete wound closure during the treatment period
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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