NCT01429519终止1 期
A PRELIMINARY OPEN CLINICAL STUDY, TO ASSESS THE SAFETY AND EFFICACY OF RPh201 APPLIED TOPICALLY FOR THE TREATMENT OF HARD TO HEAL CHRONIC ULCERATED WOUNDS
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- To determine the safety use of RPh201 administered topically three times a week during an overall treatment period of up to 4 weeks, with 52 days follow-up
研究概览
简要总结
The study objectives are to evaluate safety and efficacy of topical administration of RPh201 oil solution (botanical extract) for treatment of patients with hard to heal chronic ulcerated wounds.
详细描述
The study objectives are to evaluate safety and efficacy, of topical administration of RPh201 for treatment of patients with hard to heal wounds.
This is to include:
- Safety evaluation of RPh201 (botanical extract) formulated as an oil solution administered topically three times per week during an overall treatment period of up to 4 weeks in patients with hard to heal wounds.
- Efficacy assessment of wound improvement following the use of RPh201 oil solution (botanical extract) administered topically three times per week during an overall treatment period of up to 4 weeks and at the follow-up visit at 3 months after end of treatment in patients with hard to heal wounds
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants, either men or women are ≥ 18 years of age.
- •Patients must have at least one hard to heal wound of different etiologies (venous insufficiency, lymphatic insufficiency, neuropathic wounds or diabetic ulcers, post- operative and post-traumatic chronic wounds) located on the leg shin or foot.
- •The wound is refractive to healing at least 4 weeks prior to treatment, although treated by routine practice.
- •Wound area size is in the range of: 3 - 36 square centimeters.
- •Patients defined as grade C or above on the granulometer scale (see section 6.5.1).
- •Participants understand the nature of the procedure and provide written informed consent prior to any study procedure.
- •Women of child bearing potential must use adequate birth-control precautions.
排除标准
- •Clinically significant arterial vascular disease with ABI index <0.45 if the peripheral pulse is not palpable, or flatted PVR in case of non palpable arteries.
- •Clinical evidence for presence of infection in the soft tissue, joint and/or bone (osteomyelitis).
- •Wound has Non-viable tissue which covers more than 50% of the wound area.
- •Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound.
- •The wound penetrates into deep organs and involves bone, tendon or joint
- •Wound with sinus tracts
- •Patients are receiving, or have received within one month prior to enrollment any treatment known to impair wound healing, including but not limited to: immuno-suppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
- •Treatment with a dressing containing growth factors or other biological dressings within 15 days, prior to the screening visit.
- •Patients that have a history of alcohol or drug abuse within the last two years.
- •Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
- •Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
- •Clinically significant and/or uncontrolled condition or other significant medical disease
研究组 & 干预措施
Treatment
Experimental
干预措施: RPh201, botanical drug product (Drug)
结局指标
主要结局
To determine the safety use of RPh201 administered topically three times a week during an overall treatment period of up to 4 weeks, with 52 days follow-up
时间窗: 90 days
* Safety evaluation - To demonstrate safety using the RPh201 oil solution in terms of skin irritation score to be less than 2 for erythema /edema individual subject's results or less then 1.9 for Primary Irritation Index (PII) category (see section 6.5.2 and APPENDIX 2) . * Safety evaluation - To demonstrate safety of using RPh201 oil solution in terms of type and severity of adverse events.
次要结局
- To obtain preliminary data on the efficacy of RPh201 on improving wound status in patients with hard to heal chronic ulcerated wounds(90 days)
研究者
研究点 (1)
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